Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)
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|ClinicalTrials.gov Identifier: NCT00424008|
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : November 1, 2010
Last Update Posted : April 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Mometasone furoate/formoterol (MF/F) MDI Drug: Fluticasone propionate/salmeterol (F/SC) DPI||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||722 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids|
|Study Start Date :||April 2007|
|Primary Completion Date :||November 2008|
|Study Completion Date :||November 2008|
Resource links provided by the National Library of Medicine
Drug Information available for: Formoterol fumarate Formoterol Fluticasone propionate Mometasone furoate Salmeterol Fluticasone Salmeterol xinafoate Mometasone furoate monohydrate Fluticasone furoateU.S. FDA Resources
Experimental: MF/F MDI 200/10 mcg BID
Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily.
Drug: Mometasone furoate/formoterol (MF/F) MDI
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks.
Other Name: SCH 418131
Active Comparator: F/SC DPI 250/50 mcg BID
Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID
Drug: Fluticasone propionate/salmeterol (F/SC) DPI
Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.
Other Name: Advair Diskus in the US/Seretide Diskus outside the US
Primary Outcome Measures :
- The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Baseline to Week 12 ]
Secondary Outcome Measures :
- Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1 [ Time Frame: Baseline to 5 minutes post-dose on Day 1 ]PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval.
- Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint [ Time Frame: Baseline to Week 12 ]The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period.
- The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period. [ Time Frame: Baseline to Week 12 ]For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods.
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