This is a randomized, assessor-blind, placebo controlled, multicenter, clinical endpoint bioequivalence study to compare the efficacy and safety of generic fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd) to Flovent HFA (fluticasone propionate inhalation aerosol) 44 mcg (GSK group of companies) in treatment of patients with bronchial asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
790
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation
Investigational Site 9
Ahmedabad, Gujarat, India
RECRUITINGInvestigational Site 2
Aurangabad, Maharashtra, India
RECRUITING- Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period
Time frame: From Baseline to last day of 4-week treatment period
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Investigational Site 6
Nagpur, Maharashtra, India
RECRUITINGInvestigational Site 16
Nashik, Maharashtra, India
ACTIVE_NOT_RECRUITINGInvestigational Site 11
Nashik, Maharashtra, India
ACTIVE_NOT_RECRUITINGInvestigational Site 10
Nashik, Maharashtra, India
ACTIVE_NOT_RECRUITINGInvestigational Site 3
Pune, Maharashtra, India
RECRUITINGInvestigational Site 1
Pune, Maharashtra, India
RECRUITINGInvestigational Site 4
Jaipur, Rajasthan, India
RECRUITINGInvestigational Site 13
Hyderabad, Telangana, India
RECRUITING...and 1 more locations