A Multicenter, Randomized, Parallel-group, Placebo-controlled, 4-week Clinical Endpoint Bioequivalence Study Comparing Fluticasone Propionate/Salmeterol 100/50 µg Inhalation Powder With Advair® Diskus 100/50 µg in Asthma Patients
Overview
- Phase
- Phase 3
- Intervention
- Fluticasone propionate/salmeterol 100/50 µg
- Conditions
- Bronchial Asthma
- Sponsor
- Cipla Ltd.
- Enrollment
- 1366
- Locations
- 1
- Primary Endpoint
- Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in adult patients with asthma.
Detailed Description
This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points in adult patients with asthma.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Test
Fluticasone propionate/salmeterol 100/50 µg
Intervention: Fluticasone propionate/salmeterol 100/50 µg
Comparator
Fluticasone propionate/salmeterol 100/50 µg
Intervention: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT
Placebo
Test Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours)
Time Frame: one day
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment