To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
761
Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
QVAR® 40 mcg (Beclomethasone Dipropionate HFA)
Placebo Product
Beach Clinical Research, Inc.
Huntington Beach, California, United States
Downtown La Research Center
Los Angeles, California, United States
Moonshine Research Center
Doral, Florida, United States
Baseline-adjusted, pre-dose FEV1 on the last day of the 4-week treatment period
FEV1 measured in the morning prior dosing of inhaled medications on the last day of the 4-week treatment. The primary endpoint should be baseline adjusted (change from baseline).
Time frame: 4 weeks
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Hope Clinical Trials, Inc.
Miami, Florida, United States
San Marcus Research Clinic, Inc.
Miami Lakes, Florida, United States
Advanced Research for Health Improvement
Naples, Florida, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Innovation Research Center
Palmetto Bay, Florida, United States
Florida Premier Research Institute
Winter Park, Florida, United States
Monroe BioMedical Research
Monroe, North Carolina, United States
...and 2 more locations