A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476)
| Status: | Archived |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | March 2012 |
A Randomized, Evaluator-Blind, Crossover, Single Dose Study of the Bronchodilator Effect of Formoterol Fumarate in Combination With Mometasone Furoate Metered Dose Inhaler Delivered With and Without a Spacer Versus Placebo and Foradil® Aerolizer® in Children With Persistent Asthma (P06476)
A study to compare the bronchodilatory effect of a single dose of Mometasone
Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and
without a AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus
Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder
inhaler (DPI). Participants will be randomly assigned to 1 of 6 treatment sequences and each
participant will receive a single dose of each of 4 treatments in each period. Each
treatment period is separated by a 5 to 7 day washout period. It assumed that a single dose,
MF/F MDI 100/10 mcg delivered with a spacer will produce bronchodilation, defined as a
significant increase in FEV1 AUC(0-12 hr) when compared to placebo.
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