A Study to Determine the Efficacy and Safety of Two Mometasone Dry Powder Inhalers in the Treatment of Asthma (Study P02524)
|ClinicalTrials.gov Identifier: NCT00817817|
Recruitment Status : Completed
First Posted : January 7, 2009
Last Update Posted : March 28, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is an open-label, comparative, randomized, parallel, multicenter study in asthmatics to determine whether the administration of dry powder inhaled mometasone furoate (MF) 400 μg in a monodose capsule device would be comparable to administration of powder inhaled MF 400 μg in a multidose device.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: MF||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Comparative, Randomized, Parallel, Multicenter Study to Determine the Efficacy and Safety of Two Dry Powder Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma|
|Actual Study Start Date :||October 1, 2002|
|Actual Primary Completion Date :||May 1, 2003|
|Actual Study Completion Date :||May 1, 2003|
|Experimental: Group 1||
One evening dose of dry powder inhaled MF 400 μg (Multidose device).
|Experimental: Group 2||
One evening dose of dry powder inhaled 400 μg (400 μg capsules - Monodose).
Primary Outcome Measures :
- The assessment of efficacy will be done by spirometry, determining the difference in FEV1 and PEFR measured by spirometry on baseline, 7, 14, 28, 42 and 56 days after initiation of MF dry powder inhaler (DPI) therapy. [ Time Frame: Baseline, 7, 14, 28, 42, and 56 days after initiation of MF DPI therapy. ]
- To determine the number of puffs/day of rescue medication (Salbutamol). [ Time Frame: Daily ]
Secondary Outcome Measures :
- To compare the PEFR daily measurements obtained by Peak flow Meter used by subjects at home. [ Time Frame: Daily ]
- To compare the daily scores for asthma symptoms and sleep quality. [ Time Frame: Every morning ]
- To compare the evaluation of response to therapy made by the investigator at each visit compared to the Baseline visit. [ Time Frame: Visits 2 to 6. ]
- To determine and compare the safety (HPA axis evaluation) of both treatments using 400 μg MF DPI once daily in adult subjects with asthma. [ Time Frame: Visits 2 to 6 ]
- To determine and compare the safety (clinical laboratory measurements) of both treatments using 400 μg MF DPI once daily in adult subjects with asthma. [ Time Frame: Visit 6 ]
- To determine and compare the tolerability (adverse events) of both treatments using 400 μg MF DPI once daily in adult subjects with asthma. [ Time Frame: Visits 2 to 6. ]
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