Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,767
Unnamed facility
Sofia, Bulgaria
Unnamed facility
Hamburg, Germany
Unnamed facility
Budapest, Hungary
Unnamed facility
Riga, Latvia
Annual rate of moderate and severe COPD exacerbations
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
Time frame: 52 weeks
Annual rate of moderate and severe COPD exacerbations
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)
Time frame: 52 Weeks
Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study.
To compare flutiform (at each dose) with formoterol 12 µg (1 puff BID) for the secondary efficacy, and safety endpoints.
Time frame: 52 Weeks
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Unnamed facility
Vilnius, Lithuania
Unnamed facility
Skopje, North Macedonia
Unnamed facility
Trzemeszno Lubuskie, Poland
Unnamed facility
Bacau, Romania
Unnamed facility
Moscow, Russia
Unnamed facility
Prešov, Slovakia
...and 5 more locations