Clinical Trial Results:
Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and Quality of Life impact of Mometasone Furoate dry powder 400 mcg Once-daily in persistent mild-moderate asthmatic patients at least 12 years old.
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Summary
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EudraCT number |
2014-004926-17 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
01 Sep 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Apr 2016
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First version publication date |
19 Jul 2015
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Other versions |
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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 |
P04879
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00687531 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Merck Registration Number: MK-0887-125 | ||
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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 |
01 Sep 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Sep 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Sep 2009
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Open label, 12-week clinical trial to assess efficacy, safety, treatment adherence and Quality of Life impact of Mometasone Furoate dry powder 400 mcg once-daily in persistent mild-moderate asthmatic patients at least 12 years old.
The primary endpoint was the mean change from Baseline to the study endpoint in the FEV1 (percentage change from baseline).
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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.
The following additional measure(s) defined for this individual study was (were) in place for the protection of trial subjects: Participants could use salbutamol as rescue medication and were to record daily usage in a diary. Participants were to withhold salbutamol for at least 6 hours prior to spirometry.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Nov 2006
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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 |
Mexico: 385
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Worldwide total number of subjects |
385
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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) |
68
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Adults (18-64 years) |
299
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From 65 to 84 years |
18
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||
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Pre-assignment
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Screening details |
385 participants enrolled and were screened for eligibility for treatment assignment. A total of 281 participants received at least one dose of study medication and were included in the Intention-To-Treat (ITT) Population. 104 participants did not receive treatment due to lack of compliance of Inhaled corticosteroid (ICS) Dose Reduction. | ||||||||||||||
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Pre-assignment period milestones
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Number of subjects started |
385 | ||||||||||||||
Number of subjects completed |
281 | ||||||||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Lack of compliance of ICS Dose Reduction: 104 | ||||||||||||||
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Period 1
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Period 1 title |
Treatment Period-ITT (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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Mometasone Furoate | ||||||||||||||
Arm description |
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Mometasone Furoate Dry Powder Inhaler
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Investigational medicinal product code |
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Other name |
SCH 032088, MK-0887, ELOVENT® TWISTHALER®, Asmanex ®
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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 |
Mometasone Furoate 400 mcg once daily, in the evening through 12 weeks.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The worldwide number reflects the total number of participants enrolled in the study and screened for eligibility (n=385). The number of participants in the Baseline Period reflects the number of participants who received at least one dose of study medication (ITT Population) and was the primary analysis population for this study. |
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Baseline characteristics reporting groups
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Reporting group title |
Mometasone Furoate
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Reporting group description |
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Mometasone Furoate
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Reporting group description |
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. | ||
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End point title |
Forced Expiratory Volume in 1 second (FEV1) [1] | ||||||||||||
End point description |
Spirometry was performed to measure FEV1, which is the amount of air the participant is able to exhale in 1 second. Normal values for FEV1 in healthy people depend on age and gender, but values between 80% and 120% of the normal value is considered good. Increased FEV1 indicates improvement in asthma control.
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End point type |
Primary
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End point timeframe |
Day 1 and Week 12
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No between-group statistical analyses were performed for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR) | ||||||||||||||||
End point description |
Participants were to record their daily AM and PM PEFR values in a diary. PEFR can be measured using a peak flow meter that was given to the participant. Normal readings are based on a person's gender, age, and height. A reading of 80 to 100% of the usual or normal peak flow readings indicate that the asthma is under good control. Increased PEFR indicates improvement in asthma control.
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End point type |
Secondary
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End point timeframe |
Day 1 and Week 12
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Number of items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire that had a significant (positive) change from Baseline to endpoint | ||||||||
End point description |
Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...
The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question.
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End point type |
Secondary
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End point timeframe |
Day 1 and Week 12
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| No statistical analyses for this end point | |||||||||
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End point title |
Morning and evening asthma symptoms based on a 3 point scale (4 individual symptoms) and 24 points (summed) | ||||||||
End point description |
The symptoms of cough, chest tightness, wheezing, and shortness of breath were each to be graded on a scale of 0 to 3 with 0 being no symptoms present and 3 being very marked symptoms which was disturbing most of the time. Scores were to have been recorded at 12AM and 12PM for a total of 24 points summed.
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End point type |
Secondary
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End point timeframe |
Day 1 and Week 12
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| Notes [2] - This analysis was not performed due to missing data at the sites. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Nocturnal Awakenings | ||||||||
End point description |
Participants were to record the number of Nocturnal Awakenings with/without the use of rescue medication in each episode in the diary card since the screening visit.
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End point type |
Secondary
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End point timeframe |
Day 1 and Week 12
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| Notes [3] - This analysis was not performed due to missing data at the sites. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of puffs of salbutamol used daily | ||||||||
End point description |
Participants recorded daily rescue medication (salbutamol) use in their daily diaries.
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End point type |
Secondary
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End point timeframe |
Day 1 and Week 12
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| Notes [4] - This analysis was not performed due to missing data at the sites. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of participants with one or more mild, moderate or severe asthma exacerbations | ||||||||
End point description |
Exacerbation severity was to be characterized based on exacerbation classification from the Global Initiative for Asthma (GINA) workshop 2005 and the National Heart Lung and Blood Institute (NHLBI) asthma guidelines.
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End point type |
Secondary
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End point timeframe |
Day 1 and Week 12
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| Notes [5] - This analysis was not performed due to missing data at the sites. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Investigator’s assessment of Response to Therapy based on a 5-point scale | ||||||||
End point description |
The investigator will assess the subject's response to therapy by interviewing the subject and comparing their current level of symptoms with those noted at Baseline. A scale of 1 to 5 was to be used: 1 = much improved (AM and PM symptom severity and frequency improve >75% from baseline), 2= Improved (AM and PM symptom severity and frequency improve between 50-75% , 3 = No change (AM and PM asthma symptoms persists at the same severity and frequency from baseline), 4 = Worse (AM and PM asthma symptoms severity and frequency got worse between 50-75% from baseline), or 5 = Much worse (AM and PM asthma symptoms severity and frequency got worse more than 75% from baseline).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 12
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| Notes [6] - This analysis was not performed due to missing data at the sites. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Patient’s assessment of Response to Therapy based on a 5-point scale | ||||||||
End point description |
Participants were to assess their response to therapy at the Final Visit (week 12) by comparing their current level of symptoms with those noted at Baseline.
A scale of 1 to 5 was to be used: 1 = much improved (AM and PM symptom severity and frequency improve >75% from baseline), 2= Improved (AM and PM symptom severity and frequency improve between 50-75% , 3 = No change (AM and PM asthma symptoms persists at the same severity and frequency from baseline), 4 = Worse (AM and PM asthma symptoms severity and frequency got worse between 50-75% from baseline), or 5 = Much worse (AM and PM asthma symptoms severity and frequency got worse more than 75% from baseline).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 12
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| Notes [7] - This analysis was not performed due to missing data at the sites. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of participants who adhered to treatment | ||||||||||||||
End point description |
The compliance was measured via medication consumption. In the end of the last week of study (Week 12), a review of the remaining study drug in the initial prescribed Twisthaler device was done. A Twisthaler reading of 0 indicates no study drug left and full compliance.
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End point type |
Secondary
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End point timeframe |
Day 1 to Week 12
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Participants with Use of Rescue Medication in each episode | ||||||||
End point description |
Participants were to record the use of rescue medication in each episode in the diary card since the screening visit.
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End point type |
Secondary
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End point timeframe |
Day 1 and Week 12
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| Notes [8] - This analysis was not performed due to missing data at the sites. |
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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 |
From Screening visit up to 30 days post study completion/discontinuation (up to 16 weeks)
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Assessment type |
Systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
12
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Reporting groups
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Reporting group title |
Mometasone Furoate
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Reporting group description |
Mometasone Furoate 400 mcg once daily in the evening through 12 weeks. | ||||||||||
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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: There were no treatment-emergent adverse events reported on study. |
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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? Yes | |||||||
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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. | |||||||
| Protocol deviations may have occurred that resulted in quality issues associated with reporting of the data. | |||||||
