The purpose of this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with mild to moderate asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
475
FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks.
Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks.
Change in Forced Expiratory Volume in 1 s (FEV-1) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy
Time frame: Week 0 and 12 visits
Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR).
Time frame: Whole duration of study
Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR).
Time frame: Whole duration of study
Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs.
Time frame: Whole duration of study
Serial 12-hour FEV-1 area under the curve (AUC).
Time frame: Week 0, 2 and 12 visits
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Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks.
Research Site
Pell City, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Cypress, California, United States
Research Site
Encinitas, California, United States
Research Site
Fountain Valley, California, United States
Research Center
Los Angeles, California, United States
Research Site
Mission Hills, California, United States
Research Site
Centennial, Colorado, United States
Research Site
Colorado Springs, Colorado, United States
Research Site
Englewood, Colorado, United States
...and 47 more locations