A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
Status:
Completed
Trial end date:
2015-01-29
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to demonstrate the dose-related efficacy, by
evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent
predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of
three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler
(MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive,
with persistent asthma. The primary hypothesis of this study is that at least one dose of MF
MDI BID increases lung function, defined as a significant increase in percent predicted FEV1,
when compared to Placebo.