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)

Mundipharma Research Limited0 sites923 target enrollmentSeptember 2014

ConditionsChronic Obstructive Pulmonary Disease

InterventionsFlutiform 500/20 µg BID Flutiform 250/10 µg BID Seretide Accuhaler 50/500 µg BID

DrugsFlutiform 500/20 µg BID Flutiform 250/10 µg BID Seretide Accuhaler 50/500 µg BID

Overview

Phase: Phase 2
Intervention: Flutiform 500/20 µg BID
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Mundipharma Research Limited
Enrollment: 923
Primary Endpoint: Average pre-dose FEV1
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel