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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)
The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).
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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Fitzroy, Australia
Beijing, China
Wellington, New Zealand
Seoul, South Korea
Taipei, Taiwan
Start Date
September 1, 2014
Primary Completion Date
May 1, 2016
Completion Date
May 1, 2016
Last Updated
March 28, 2017
923
ACTUAL participants
Flutiform 500/20 µg BID
DRUG
Flutiform 250/10 µg BID
DRUG
Seretide Accuhaler 50/500 µg BID
DRUG
Lead Sponsor
Mundipharma Research Limited
NCT07477600
NCT05878769
NCT06717659
Data Source & Attribution
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