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A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
A Randomised, Double-blind, Double Dummy, Parallel Group Study Comparing Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 250/10 µg (2 Puffs BID) and Flutiform® 125/5 µg (2 Puffs BID) Versus Formoterol Fumarate Dihydrate (Atimos®) 12 µg (1 Puff BID) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Summary

Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.

Clinical Trial Description

This study is a multi-centre, randomised, double-blind, active-controlled, parallel-group study, in male and female subjects who will be assigned into 1 of 3 treatment groups based on 1:1:1 ratio. Following a 2 week run-in phase all subjects will receive treatment for 1 year (52 weeks) followed by a final follow up 2 weeks after their last visit, during this time subjects will be required to attend 10 clinic visits while the final follow up can be completed by telephone. Throughout the study subjects will be assessed on a mixture of symptom based measurements as well as lung function tests to monitor their progress in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01946620
Study type Interventional
Source Mundipharma Research Limited
Contact
Status Completed
Phase Phase 3
Start date October 2013
Completion date May 2016
View Details
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