Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12 Endpoint
in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.
|Asthma||Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID Drug: Mometasone furoate MDI (MF MDI) 200 mcg Drug: formoterol fumarate 10 mcg Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Medium-Dose Inhaled Glucocorticosteroids|
- Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF [ Time Frame: Baseline to Endpoint (12 weeks) ]
- Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F [ Time Frame: 26-week Treatment Period ]This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation)
- Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score [ Time Frame: Baseline to Week 26 ]AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled.
- Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline to week 26 ]ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case).
- Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) [ Time Frame: Baseline to Endpoint ]Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled.
- Number of Participants With at Least One Severe Asthma Exacerbation [ Time Frame: Baseline to Week 26 ]
A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period:
- A decrease in FEV1 below the Treatment Period stability limit at any visit,
- A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days,
- An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication.
|Study Start Date:||September 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Experimental: MF/F MDI 200/10 mcg BID||
Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
Other Name: SCH 418131
|Experimental: MF MDI 200 mcg BID||
Drug: Mometasone furoate MDI (MF MDI) 200 mcg
MF 200 mcg via metered dose inhaler twice daily for 26 weeks
Other Name: SCH 32088
|Experimental: F MDI 10 mcg BID||
Drug: formoterol fumarate 10 mcg
F via metered dose inhaler 10 mcg twice a day for 26 weeks
Other Name: Foradil
|Placebo Comparator: Placebo BID||
Placebo metered dose inhaler twice a day for 26 weeks