NCT03394989

BE Study of Fluticasone Propionate/Salmeterol Inhalation Powder in Asthma Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,366 (actual)
• Sponsor: Cipla Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone propionate/salmeterol 100/50 µg	Test Arm: Dry powder inhaler
OTHER	Placebo	Placebo
DRUG	Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT	Comparator Arm: Dry powder inhaler

Timeline

• Start date: 2018-10-17
• Primary completion: 2019-12-03
• Completion: 2020-03-31
• First posted: 2018-01-09
• Last updated: 2020-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study