NCT01946620

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

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,767 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Flutiform
DRUG	Formoterol

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2013-09-19
• Last updated: 2018-10-24

Locations

15 sites across 15 countries: Bulgaria, Germany, Hungary, Latvia, Lithuania, North Macedonia, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Ukraine, United Kingdom