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, in adult and adolescent patients with mild to moderate asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
357
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 100 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) from morning predose at Baseline (Week 0) to predose at Week 12
Time frame: Week 0 and 12
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 include adverse events, ECGs, clinical laboratory tests and vital signs.
Time frame: Whole duration of study
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Research Site
Birmingham, Alabama, United States
Research Site
Mission Viejo, California, United States
Research Site
Orange, California, United States
Research Site
San Jose, California, United States
Research Site
Vista, California, United States
Research Site
Denver, Colorado, United States
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Lilburn, Georgia, United States
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Savannah, Georgia, United States
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Park City, Kansas, United States
Research Site
Bethesda, Maryland, United States
...and 31 more locations