Trials / Unknown
UnknownNCT05363202
To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma
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.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 790 (estimated)
- Sponsor
- Glenmark Pharmaceuticals Ltd. India · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluticasone propionate Inhalation Aerosol 44 mcg | 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 |
| DRUG | FLOVENT HFA 44 mcg | 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 |
| DRUG | Matching Placebo inhaler | 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 |
Timeline
- Start date
- 2022-04-15
- Primary completion
- 2024-05-30
- Completion
- 2024-08-30
- First posted
- 2022-05-05
- Last updated
- 2022-05-27
Locations
11 sites across 1 country: India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05363202. Inclusion in this directory is not an endorsement.