NCT02195375

Flutiform® Compared With Seretide® in the Treatment of COPD

A Randomised Double-blind, Double-dummy Parallel Group Study to Compare the Efficacy and Safety of Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 500/20 µg BID and 250/10 µg BID Versus Salmeterol / Fluticasone (Seretide®) 50/500 µg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 923 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).

Detailed description

A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of COPD. Subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Flutiform 500/20 µg BID
DRUG	Flutiform 250/10 µg BID
DRUG	Seretide Accuhaler 50/500 µg BID

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-07-21
• Last updated: 2017-03-28

Locations

5 sites across 5 countries: Australia, China, New Zealand, South Korea, Taiwan