Clinical Trial Results:
A Randomized, Evaluator-Blind, Crossover, Single Dose Study of the Bronchodilator Effect of Formoterol Fumarate in Combination With Mometasone Furoate Metered Dose Inhaler Delivered With and Without a Spacer Versus Placebo and Foradil® Aerolizer® in Children With Persistent Asthma (Protocol No. P06476)
Summary
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EudraCT number |
2014-004582-24 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
15 Oct 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Feb 2016
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First version publication date |
30 Jul 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
P06476
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01258803 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Merck protocol number: MK-0887A-178 | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Oct 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Oct 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Oct 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant was to receive a single dose of each of 4 treatments in each period. Each treatment period was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10 mcg delivered with a spacer would produce bronchodilation, defined as a significant increase in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Dec 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 92
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Worldwide total number of subjects |
92
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
92
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited from 28 study sites in the United States. Primary Therapy Period: December 2010 to October 2011. | ||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
The study included a 4-week Run-In Period during which participants were treated with Mometasone Furoate (MF) Dry Powdered Inhaler (DPI) 100 mcg. | ||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Treatment Period 1 (1 dose)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator [1] | ||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Treatment Sequence 1 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI) | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
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Investigational medicinal product code |
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Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Placebo MDI with spacer
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Arm title
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Treatment Sequence 2 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
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Investigational medicinal product code |
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Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Placebo MDI with spacer
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Arm title
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Treatment Sequence 3 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Placebo MDI with spacer
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Arm title
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Treatment Sequence 4 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
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Investigational medicinal product code |
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Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
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||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Placebo MDI without spacer
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Arm title
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Treatment Sequence 5 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
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||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
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||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
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||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
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||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
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||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
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||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
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||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
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||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
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||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
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||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
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||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 6 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: This was an evaluator-blind study. The investigator, clinical study staff and personnel performing the assessments and data analysis were to remain blinded to the identity of the study medication and treatment sequence. The Third-Party Dispenser was the only one at the site who knew the treatment assignment of each subject. |
|||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
Period 2
|
|||||||||||||||||||||||||||||||||||||||||||
Period 2 title |
Treatment Period 2 (1 dose)
|
||||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||||||||
Blinding used |
Single blind | ||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator [2] | ||||||||||||||||||||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 1 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo MDI with spacer, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F DPI | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 2 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 3 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Treatment Sequence | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 4 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 5 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 6 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Treatment Sequence | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Notes [2] - The roles blinded appear inconsistent with a simple blinded trial. Justification: This was an evaluator-blind study. The investigator, clinical study staff and personnel performing the assessments and data analysis were to remain blinded to the identity of the study medication and treatment sequence. The Third-Party Dispenser was the only one at the site who knew the treatment assignment of each subject. |
|||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
Period 3
|
|||||||||||||||||||||||||||||||||||||||||||
Period 3 title |
Treatment Period 3 (1 dose)
|
||||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||||||||
Blinding used |
Single blind | ||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator [3] | ||||||||||||||||||||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 1 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI) | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 2 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 3 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 4 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 5 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 6 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
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Investigational medicinal product code |
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Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
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Pharmaceutical forms |
Inhalation solution
|
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Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
|
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Pharmaceutical forms |
Inhalation solution
|
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Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Investigational medicinal product name |
Placebo MDI without spacer
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
|
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Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
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Notes [3] - The roles blinded appear inconsistent with a simple blinded trial. Justification: This was an evaluator-blind study. The investigator, clinical study staff and personnel performing the assessments and data analysis were to remain blinded to the identity of the study medication and treatment sequence. The Third-Party Dispenser was the only one at the site who knew the treatment assignment of each subject. |
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Period 4
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Period 4 title |
Treatment Period 4 (1 dose)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator [4] | ||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
|
Treatment Sequence 1 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo MDI with spacer, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F DPI | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
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Pharmaceutical forms |
Inhalation powder
|
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Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
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Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Investigational medicinal product name |
Placebo MDI with spacer
|
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Arm title
|
Treatment Sequence 2 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Treatment Sequence | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Arm title
|
Treatment Sequence 3 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Arm title
|
Treatment Sequence 4 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Treatment Sequence | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Arm title
|
Treatment Sequence 5 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Treatment Sequence | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 418131, MK-0877A
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo MDI without spacer
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation solution
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
||||||||||||||||||||||||||||||||||||||||||
Arm title
|
Treatment Sequence 6 | ||||||||||||||||||||||||||||||||||||||||||
Arm description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Formoterol Fumarate DPI
|
||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||||
Other name |
SCH 045571, MK-5571, Foradil® Aerolizer®
|
||||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Inhalation powder
|
||||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
|
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer
|
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
|
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Pharmaceutical forms |
Inhalation solution
|
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Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Investigational medicinal product name |
Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer
|
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Investigational medicinal product code |
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Other name |
SCH 418131, MK-0877A
|
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Pharmaceutical forms |
Inhalation solution
|
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Routes of administration |
Inhalation use
|
||||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Investigational medicinal product name |
Placebo MDI without spacer
|
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
|
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Routes of administration |
Inhalation use
|
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Dosage and administration details |
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
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Notes [4] - The roles blinded appear inconsistent with a simple blinded trial. Justification: This was an evaluator-blind study. The investigator, clinical study staff and personnel performing the assessments and data analysis were to remain blinded to the identity of the study medication and treatment sequence. The Third-Party Dispenser was the only one at the site who knew the treatment assignment of each subject. |
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Baseline characteristics reporting groups
|
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Reporting group title |
Treatment Period 1 (1 dose)
|
|||||||||||||||||||||||||||||||||||||||
Reporting group description |
All Randomized Participants | |||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Treatment Sequence 1
|
||
Reporting group description |
Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI) | ||
Reporting group title |
Treatment Sequence 2
|
||
Reporting group description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||
Reporting group title |
Treatment Sequence 3
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||
Reporting group title |
Treatment Sequence 4
|
||
Reporting group description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||
Reporting group title |
Treatment Sequence 5
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||
Reporting group title |
Treatment Sequence 6
|
||
Reporting group description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||
Reporting group title |
Treatment Sequence 1
|
||
Reporting group description |
Treatment Period 1: Placebo MDI with spacer, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F DPI | ||
Reporting group title |
Treatment Sequence 2
|
||
Reporting group description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||
Reporting group title |
Treatment Sequence 3
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||
Reporting group title |
Treatment Sequence 4
|
||
Reporting group description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||
Reporting group title |
Treatment Sequence 5
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||
Reporting group title |
Treatment Sequence 6
|
||
Reporting group description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||
Reporting group title |
Treatment Sequence 1
|
||
Reporting group description |
Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI) | ||
Reporting group title |
Treatment Sequence 2
|
||
Reporting group description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||
Reporting group title |
Treatment Sequence 3
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||
Reporting group title |
Treatment Sequence 4
|
||
Reporting group description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||
Reporting group title |
Treatment Sequence 5
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||
Reporting group title |
Treatment Sequence 6
|
||
Reporting group description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||
Reporting group title |
Treatment Sequence 1
|
||
Reporting group description |
Treatment Period 1: Placebo MDI with spacer, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F DPI | ||
Reporting group title |
Treatment Sequence 2
|
||
Reporting group description |
Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer | ||
Reporting group title |
Treatment Sequence 3
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer | ||
Reporting group title |
Treatment Sequence 4
|
||
Reporting group description |
Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer | ||
Reporting group title |
Treatment Sequence 5
|
||
Reporting group description |
Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer | ||
Reporting group title |
Treatment Sequence 6
|
||
Reporting group description |
Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI | ||
Subject analysis set title |
MF/F MDI with spacer
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
|
||
Subject analysis set title |
MF/F MDI without spacer
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
|
||
Subject analysis set title |
F DPI
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants receiving a single dose of F DPI 20 mcg
|
||
Subject analysis set title |
Placebo MDI with or without spacer
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants receiving a single dose of Placebo MDI with or without a spacer
|
|
|||||||||||||
End point title |
Area Under the Curve From 0-12 hours (AUC[0-12h]) of the Change From baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer | ||||||||||||
End point description |
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Up to 12 hours postdose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
AUC(0-12h) chg from BL in FEV1 after single dose | ||||||||||||
Statistical analysis description |
Pairwise Treatment Comparison of MF/F MDI with spacer and Placebo MDI combined with or without spacer. Analysis was performed using an analysis of covariance (ANCOVA) model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate.
|
||||||||||||
Comparison groups |
MF/F MDI with spacer v Placebo MDI with or without spacer
|
||||||||||||
Number of subjects included in analysis |
158
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.124
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.094 | ||||||||||||
upper limit |
0.154 |
|
|||||||||||||
End point title |
AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer | ||||||||||||
End point description |
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 12 hours postdose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
AUC(0-12h) chg from BL in FEV1 after single dose | ||||||||||||
Statistical analysis description |
Pairwise Treatment Comparison of MF/F MDI without spacer and Placebo MDI combined with or without spacer. Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate.
|
||||||||||||
Comparison groups |
MF/F MDI without spacer v Placebo MDI with or without spacer
|
||||||||||||
Number of subjects included in analysis |
158
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.102
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.073 | ||||||||||||
upper limit |
0.131 |
|
|||||||||||||
End point title |
AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer | ||||||||||||
End point description |
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 12 hours postdose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
AUC(0-12h) chg from BL in FEV1 after single dose | ||||||||||||
Statistical analysis description |
Pairwise Treatment Comparison of MF/F MDI with spacer and MF/F MDI without spacer. Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate.
|
||||||||||||
Comparison groups |
MF/F MDI with spacer v MF/F MDI without spacer
|
||||||||||||
Number of subjects included in analysis |
158
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.144 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.022
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.008 | ||||||||||||
upper limit |
0.052 |
|
|||||||||||||
End point title |
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI | ||||||||||||
End point description |
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 12 hours postdose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
AUC(0-12h) chg from BL in FEV1 after single dose | ||||||||||||
Statistical analysis description |
Pairwise Treatment Comparison of MF/F MDI with spacer and F DPI.
Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate.
|
||||||||||||
Comparison groups |
MF/F MDI with spacer v F DPI
|
||||||||||||
Number of subjects included in analysis |
158
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.229 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.018
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.012 | ||||||||||||
upper limit |
0.048 |
|
|||||||||||||
End point title |
AUC (0-12h) of the Change from Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI | ||||||||||||
End point description |
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 12 hours postdose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
AUC(0-12h) chg from BL in FEV1 after single dose | ||||||||||||
Statistical analysis description |
Pairwise Treatment Comparison of MF/F MDI without spacer and F DPI.
Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate.
|
||||||||||||
Comparison groups |
MF/F MDI without spacer v F DPI
|
||||||||||||
Number of subjects included in analysis |
158
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.79 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.004
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-0.033 | ||||||||||||
upper limit |
0.025 |
|
|||||||||||||
End point title |
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer | ||||||||||||
End point description |
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, space and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 12 hours postdose
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
AUC(0-12h) chg from BL in FEV1 after single dose | ||||||||||||
Statistical analysis description |
Pairwise Treatment Comparison of F DPI and Placebo MDI combined with or without spacer. Analysis was performed using an ANCOVA model extracting the effects due to treatment, sequence, subject (random effect nested within sequence), period, age groups (5 to 7 years and 8 to 11 years) and Baseline FEV1 as a covariate.
|
||||||||||||
Comparison groups |
F DPI v Placebo MDI with or without spacer
|
||||||||||||
Number of subjects included in analysis |
158
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.106
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.077 | ||||||||||||
upper limit |
0.135 |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Baseline was defined as the average of 2 predose FVC measurements (taken 30 minutes and immediately before dosing). The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry
maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Change from Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Baseline was defined as the average of 2 predose measurements (taken 30 minutes and immediately before dosing). The analysis population for this endpoint included all participants who received each assigned single-dose treatment, performed at least the 0- and 2-hour spirometry evaluations and met the following criteria: did not use any prohibited concomitant medications; demonstrated satisfactory use of inhaler, spacer and spirometry maneuvers; and used >80% of prescribed MF DPI across the entire study treatment.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose
|
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 90 days)
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Adverse event reporting additional description |
The Safety Population consisted of all randomized participants who received at least one dose of the study drug.
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Assessment type |
Systematic | |||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
MF/F MDI with spacer
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Reporting group description |
Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer | |||||||||||||||||||||||||
Reporting group title |
F DPI
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Reporting group description |
Participants receiving a single dose of F DPI 20 mcg | |||||||||||||||||||||||||
Reporting group title |
Placebo MDI with or without spacer
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Reporting group description |
Participants receiving a single dose of Placebo MDI with or without a spacer | |||||||||||||||||||||||||
Reporting group title |
MF/F MDI without spacer
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Reporting group description |
Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer | |||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: In this study, no non-serious adverse events reached the 5% frequency threshold for reporting. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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26 Oct 2010 |
Amendment 1:
Changes to Inclusion Criterion 14: text added to be consistent with other references in protocol: Subject must be able to demonstrate his/her ability to perform reproducible expiratory maneuvers (including PEF), following the principles of the ATS/ERS guidelines. Text also modified in following procedures: 7.Review of prior medications, including washout times, with subject. Record of prior medication taken by subject within 30 days, or longer, if applicable as per washout requirements, before starting trial to be obtained; 14.Venous blood and urine samples specified in Table 8 (protocol) to be analyzed and reported by central laboratory using standard procedures. Urine pregnancy test for female subjects of childbearing potential to be taken at Screening Visit and Visit 5 or Discontinuation Visit; must be negative for subject to be considered for eligibility. If subject is menstruating at time of urine collection, it should be noted in the source and eCRF comment module. Female subjects who begin menses after Screening Visit will have urine pregnancy test at next scheduled visit. Subjects with positive test will be discontinued; 16.Subjects to refrain from using SABA for 6 hours prior to start of spirometry unless FEV1 falls below stability limit. Spirometry to be performed following principles of ATS/ERS guidelines; should be performed with subject sitting, using a chair with arms and without wheels; if necessary, undertake testing with subject standing or in another position and note on spirometry report; position should be consistent throughout study. Use of nose clips required; 17.Reversibility should be demonstrated within 30 minutes of bronchodilator administration. If subject does not meet reversibility at Visit 1, three repeat assessments can be performed during Run-in Period, prior to Baseline Visit; 18.e-Diary/PEF meter will collect and save relevant expiratory flow-volume parameters, use of rescue medication, and dosing information. |
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17 Dec 2010 |
Amendment 2: The only change the protocol was reinserting missing pages in Appendix 8.
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |