This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks.
Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.
Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.
FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated.
Time frame: Baseline and Week 12
Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.
The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated.
Time frame: Baseline and Week 12
Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.
The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated.
Time frame: Baseline and Week 12
Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.
The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated.
Time frame: Baseline and Week 12
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