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

Phase 3

Completed

• Conditions: Bronchial Asthma
• Interventions: Drug: Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT; Other: Placebo; Drug: Fluticasone propionate/salmeterol 100/50 µg

• Registration Number: NCT03394989
• Lead Sponsor: Cipla Ltd.

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.

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Study Start: 2018-10-17
• Status Verified: 2019-11
• Primary Completion: 2019-12-03
• Study Completion: 2020-03-31
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1366

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator	Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT	Fluticasone propionate/salmeterol 100/50 µg
Placebo	Placebo	Test Placebo
Test	Fluticasone propionate/salmeterol 100/50 µg	Fluticasone propionate/salmeterol 100/50 µg

Primary Outcome Measures

Name	Time	Method
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours)	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

Trial Locations

Locations (1)

Combined Research Orlando; 🇺🇸 Orlando, Florida, United States