909
Participants
Start Date
January 31, 2012
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2013
Fp MDPI
"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.~During the treatment period, participants were randomized to 12.5, 25, 50 or 100 mcg of Fp one inhalation twice a day for a total daily dose of 25, 50, 100 or 200 mcg. Study drug was administered in the morning and in the evening"
Flovent Diskus
Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 100 mcg was used twice a day, once in the morning and evening, for a total daily dose of 200 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.
albuterol/salbutamol
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Placebo MDPI
Placebo multidose dry powder inhaler in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.
Teva Investigational Site 10165, Homewood
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Collaborators (1)
PPD Development, LP
INDUSTRY
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY