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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Flutiform; Drug: Formoterol

• Registration Number: NCT01946620
• Lead Sponsor: Mundipharma Research Limited

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Study Start: 2013-10
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1767

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flutiform 125/5 micrograms	Flutiform	Flutiform 125/5 µg (2 puffs twice daily)
Flutiform 250/10 micrograms	Flutiform	Flutiform 250/10 µg (2 puffs twice daily)
Formoterol 12 micrograms	Formoterol	Formoterol 12 µg 1 puff twice daily

Primary Outcome Measures

Name	Time	Method
Annual rate of moderate and severe COPD exacerbations	52 weeks	To show superiority in the efficacy of flutiform 250/10 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations

Secondary Outcome Measures

Name	Time	Method
Annual rate of moderate and severe COPD exacerbations	52 Weeks	To show superiority in the efficacy of flutiform 125/5 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations. (Different dose to Primary Outcome)
Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study.	52 Weeks	To compare flutiform (at each dose) with formoterol 12 µg (1 puff BID) for the secondary efficacy, and safety endpoints.