Clinical Trial Results:
A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK-0476 in Patients with Chronic Asthma
Summary
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EudraCT number |
2014-004776-27 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
29 Dec 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Feb 2016
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First version publication date |
19 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 |
0476-388
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00739297 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
MK-0476-388: Merck protocol number | ||
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 |
29 Dec 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Dec 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Dec 2008
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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 |
This study tested the safety and effectiveness of a range of doses of MK-0476 (montelukast) compared to placebo on improved lung function based on forced expiratory volume in 1 second (FEV1) in participants aged 15 to 65 years with chronic asthma. This study was a 4-period crossover study during which participants were randomized to receive 3 out of the 5 possible dose strengths of montelukast and 1 dose strength of placebo over the 4 treatment periods using adaptive randomization.
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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 |
26 Jun 2008
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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: 68
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Worldwide total number of subjects |
68
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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) |
0
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Adolescents (12-17 years) |
2
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Adults (18-64 years) |
65
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited from 6 centers in the United States between July and December 2008. | ||||||||||
Pre-assignment
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Screening details |
117 participants were screened; 49 were excluded. Randomized participants met the following criteria during the prestudy period: FEV1 50-85% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction >12% following SABA at Visits 1 and 2. | ||||||||||
Period 1
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Period 1 title |
First Intervention (Visit 3 to Visit 4)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||
Arms
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Arm title
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Total Population | ||||||||||
Arm description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||
Arm type |
Total Population | ||||||||||
Investigational medicinal product name |
Placebo for montelukast
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Investigational medicinal product code |
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Other name |
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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 |
Placebo to montelukast 25 mcg or 250 mcg inhalation powder via dry powder inhaler (DPI), administered as a single dose
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Investigational medicinal product name |
Albuterol sulfate
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Investigational medicinal product code |
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Other name |
ProAir® HFA
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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 |
Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)
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Investigational medicinal product name |
Montelukast
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Investigational medicinal product code |
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Other name |
MK-0476
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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 |
Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose
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Investigational medicinal product name |
Placebo for albuterol sulfate
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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 |
Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI
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Period 2
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Period 2 title |
First Washout Period of 4-7 Days
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
No treatment was administered during the washout period.
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Arms
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Arm title
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Total Population | ||||||||||
Arm description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||
Arm type |
No intervention | ||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 3
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Period 3 title |
Second Intervention (Visit 5 to Visit 6)
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||
Arms
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Arm title
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Total Population | ||||||||||
Arm description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||
Arm type |
Total Population | ||||||||||
Investigational medicinal product name |
Placebo for montelukast
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Investigational medicinal product code |
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Other name |
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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 |
Placebo to montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered as a single dose
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Investigational medicinal product name |
Albuterol sulfate
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Investigational medicinal product code |
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Other name |
ProAir® HFA
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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 |
Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)
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Investigational medicinal product name |
Montelukast
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Investigational medicinal product code |
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Other name |
MK-0476
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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 |
Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose
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Investigational medicinal product name |
Placebo for albuterol sulfate
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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 |
Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI
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Period 4
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Period 4 title |
Second Washout Period of 4-7 Days
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
No treatment was administered during the washout period.
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Arms
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Arm title
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Total Population | ||||||||||
Arm description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||
Arm type |
No intervention | ||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 5
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Period 5 title |
Third Intervention (Visit 7 to Visit 8)
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||
Arms
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Arm title
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Total Population | ||||||||||
Arm description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||
Arm type |
Total Population | ||||||||||
Investigational medicinal product name |
Placebo for montelukast
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Investigational medicinal product code |
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Other name |
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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 |
Placebo to montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered as a single dose
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Investigational medicinal product name |
Albuterol sulfate
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Investigational medicinal product code |
|||||||||||
Other name |
ProAir® HFA
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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 |
Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)
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Investigational medicinal product name |
Montelukast
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Investigational medicinal product code |
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Other name |
MK-0476
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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 |
Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose
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Investigational medicinal product name |
Placebo for albuterol sulfate
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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 |
Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI
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Period 6
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Period 6 title |
Third Washout Period of 4-7 Days
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
No treatment was administered during the washout period.
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Arms
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Arm title
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Total Population | ||||||||||
Arm description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||
Arm type |
No intervention | ||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 7
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Period 7 title |
Fourth Intervention(Visit 9 to Visit 10)
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||
Arms
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Arm title
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Total Population | ||||||||||
Arm description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||
Arm type |
Total Population | ||||||||||
Investigational medicinal product name |
Placebo for montelukast
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Investigational medicinal product code |
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Other name |
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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 |
Placebo to montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered as a single dose
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Investigational medicinal product name |
Albuterol sulfate
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Investigational medicinal product code |
|||||||||||
Other name |
ProAir® HFA
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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 |
Albuterol sulfate 90 mcg/actuation, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded short-acting beta-agonist (SABA), administered as 2 puffs from a metered dose inhaler (MDI)
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Investigational medicinal product name |
Montelukast
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Investigational medicinal product code |
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Other name |
MK-0476
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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 |
Montelukast 25 mcg or 250 mcg inhalation powder via DPI, administered to provide 25 mcg, 100 mcg, 250 mcg, 500 mcg or 1000 mcg montelukast as a single dose
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Investigational medicinal product name |
Placebo for albuterol sulfate
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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 |
Placebo to albuterol sulfate, 4 hours after receiving blinded study medication (montelukast or placebo), participants received a single witnessed dose of blinded placebo to albuterol, administered as 2 puffs from a MDI
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Baseline characteristics reporting groups
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Reporting group title |
First Intervention (Visit 3 to Visit 4)
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Total Population
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||
Reporting group title |
Total Population
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||
Reporting group title |
Total Population
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||
Reporting group title |
Total Population
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||
Reporting group title |
Total Population
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||
Reporting group title |
Total Population
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||
Reporting group title |
Total Population
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Reporting group description |
Participants were randomized to receive 1 of 3 dose strengths of montelukast or 1 dose strength of placebo at either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after the intervention. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||
Subject analysis set title |
Montelukast+Albuterol
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Montelukast (data for each participant are pooled across all 3 of the active doses received by that participant) + Albuterol (data for each participant are pooled across all 3 administrations of active albuterol, as added to active montelukast)
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Subject analysis set title |
Montelukast+Placebo
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Montelukast (data for each participant are pooled across all 3 of the active doses received by that participant) + Placebo for albuterol (data for each participant are pooled across all 3 administrations of placebo for albuterol, as added to active montelukast)
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Subject analysis set title |
Placebo
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants were randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
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Subject analysis set title |
25 mcg Montelukast
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants were randomized to receive montelukast 25 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
|
||
Subject analysis set title |
100 mcg Montelukast
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants were randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
|
||
Subject analysis set title |
250 mcg Montelukast
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants were randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
|
||
Subject analysis set title |
500 mcg Montelukast
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants were randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
|
||
Subject analysis set title |
1000 mcg Montelukast
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Participants were randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment).
|
|
|||||||||||||||||||||||||||||
End point title |
Change from baseline in FEV1 over 4 hours | ||||||||||||||||||||||||||||
End point description |
FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
|
||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
0 (=baseline) to 4 hours after treatment with montelukast
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
Notes [1] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [2] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [3] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [4] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [5] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [6] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. |
|||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 25 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in least squares (LS) means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 25 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
25 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
109
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.096 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.04
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
-0.01 | ||||||||||||||||||||||||||||
upper limit |
0.08 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 100 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 100 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
100 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
97
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
≤ 0.001 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.1
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
0.04 | ||||||||||||||||||||||||||||
upper limit |
0.15 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 250 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 250 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
250 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
133
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.002 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.06
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
0.02 | ||||||||||||||||||||||||||||
upper limit |
0.11 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 500 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 500 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
500 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
92
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.081 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.05
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
-0.01 | ||||||||||||||||||||||||||||
upper limit |
0.11 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 1000 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means of time-weighted average change from baseline in FEV1 over 4 hours - Montelukast 1000 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
1000 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
103
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
≤ 0.001 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.08
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
0.04 | ||||||||||||||||||||||||||||
upper limit |
0.13 |
|
|||||||||||||
End point title |
Change from baseline in FEV1 over 90 minutes after albuterol/placebo administration | ||||||||||||
End point description |
FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast
|
||||||||||||
|
|||||||||||||
Notes [7] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [8] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. |
|||||||||||||
Statistical analysis title |
Difference in LS means | ||||||||||||
Statistical analysis description |
Difference in LS means of time-weighted average change from baseline in FEV1 over 90 minutes after anbuterol/placebo administration - Montelukast+Albuterol vs. Montelukast+Placebo. Based on a repeated measures model with terms for treatment (albuterol/placebo), dose, treatment-by-dose interaction and baseline FEV1.
|
||||||||||||
Comparison groups |
Montelukast+Placebo v Montelukast+Albuterol
|
||||||||||||
Number of subjects included in analysis |
67
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.015 | ||||||||||||
Method |
Repeated measures model | ||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||
Point estimate |
0.19
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
0.04 | ||||||||||||
upper limit |
0.34 |
|
|||||||||||||||||||||||||||||
End point title |
Change from baseline in FEV1 at 8 hours after treatment with montelukast | ||||||||||||||||||||||||||||
End point description |
Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.
|
||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||
End point timeframe |
0 (baseline) and 8 hours after treatment with montelukast
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
Notes [9] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [10] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [11] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [12] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [13] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [14] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. |
|||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 25 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 25 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
25 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
109
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.099 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.06
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
-0.01 | ||||||||||||||||||||||||||||
upper limit |
0.12 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 100 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 100 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
100 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
97
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.055 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.07
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
0 | ||||||||||||||||||||||||||||
upper limit |
0.15 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 250 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 250 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
250 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
133
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.097 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.05
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
-0.01 | ||||||||||||||||||||||||||||
upper limit |
0.11 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 500 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 500 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
500 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
91
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.175 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.06
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
-0.03 | ||||||||||||||||||||||||||||
upper limit |
0.14 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 1000 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means for change from baseline in FEV1 at 8 hours after montelukast administration - Montelukast 1000 mcg vs. Placebo. Based on a mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
1000 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
102
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.025 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.08
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
0.01 | ||||||||||||||||||||||||||||
upper limit |
0.15 |
|
|||||||||||||||||||||||||||||
End point title |
Change from baseline in FEV1 at 24 hours after treatment with montelukast | ||||||||||||||||||||||||||||
End point description |
Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.
|
||||||||||||||||||||||||||||
End point type |
Other pre-specified
|
||||||||||||||||||||||||||||
End point timeframe |
0 (baseline) and 24 hours after treatment with montelukast
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
Notes [15] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [16] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [17] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [18] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [19] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. [20] - All randomized participants who received ≥1 study drug dose & had baseline & post-treatment data. |
|||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 25 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 25 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
25 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
109
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.25 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.04
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
-0.03 | ||||||||||||||||||||||||||||
upper limit |
0.1 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 100 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 100 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
||||||||||||||||||||||||||||
Comparison groups |
100 mcg Montelukast v Placebo
|
||||||||||||||||||||||||||||
Number of subjects included in analysis |
96
|
||||||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.027 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.09
|
||||||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||||||
lower limit |
0.01 | ||||||||||||||||||||||||||||
upper limit |
0.17 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 250 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 250 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
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Comparison groups |
250 mcg Montelukast v Placebo
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Number of subjects included in analysis |
133
|
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.117 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.05
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-0.01 | ||||||||||||||||||||||||||||
upper limit |
0.1 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 500 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 500 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
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Comparison groups |
500 mcg Montelukast v Placebo
|
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Number of subjects included in analysis |
92
|
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Analysis specification |
Pre-specified
|
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Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.111 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.07
|
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
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lower limit |
-0.02 | ||||||||||||||||||||||||||||
upper limit |
0.15 | ||||||||||||||||||||||||||||
Statistical analysis title |
Montelukast 1000 mcg vs. Placebo | ||||||||||||||||||||||||||||
Statistical analysis description |
Difference in LS means in change from baseline in FEV1 at 24 hours after montelukast administration - Montelukast 1000 mcg vs. Placebo. Based on mixed-effects model with terms for treatment (including dose of montelukast), period and baseline FEV1.
|
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Comparison groups |
1000 mcg Montelukast v Placebo
|
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Number of subjects included in analysis |
103
|
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Analysis specification |
Pre-specified
|
||||||||||||||||||||||||||||
Analysis type |
superiority | ||||||||||||||||||||||||||||
P-value |
= 0.026 | ||||||||||||||||||||||||||||
Method |
Mixed models analysis | ||||||||||||||||||||||||||||
Parameter type |
Mean difference in least squares | ||||||||||||||||||||||||||||
Point estimate |
0.08
|
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||
sides |
2-sided
|
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lower limit |
0.01 | ||||||||||||||||||||||||||||
upper limit |
0.15 |
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Adverse events information
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Timeframe for reporting adverse events |
Up to 4 weeks (Up to 1 day after last dose of study drug)
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Adverse event reporting additional description |
The safety population consisted of all randomized participants who received at least one dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.0
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Participants were randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol was administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
25 mcg Montelukast
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Reporting group description |
Participants were randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
100 mcg Montelukast
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Reporting group description |
Participants were randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
250 mcg Montelukast
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Reporting group description |
Participants were randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
500 mcg Montelukast
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Reporting group description |
Participants were randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
1000 mcg Montelukast
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Reporting group description |
Participants were randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol was administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, participants received no study treatment (i.e., participants did not receive montelukast or placebo treatment). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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 |