Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)
Completed
Merck Sharp & Dohme Corp.
Phase 4
2006-09-01
This is a randomized, multi-center, parallel-group, active-controlled, double-blind study
evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral
density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the
averaged baseline value (the average of the two scan results prior to treatment) to the
endpoint of treatment time point (the average of the last two valid post-baseline scan
results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus
montelukast (ML) 10 mg daily in the evening.
A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Budesonide DPI in Asthmatics (Study P04880)
Completed
Merck Sharp & Dohme Corp.
Phase 3
2007-06-01
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.
Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)
Terminated
Merck Sharp & Dohme Corp.
Phase 4
2006-09-01
This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study
evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with
"Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced
expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or
end of the study).
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