The purpose of the study is to compare the efficacy, safety and tolerability of aclidinium bromide/formoterol fumarate and salmeterol/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
933
Peak Forced Expiratory Volume in One Second (FEV1) at Week 24
Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration
Time frame: At Week 24
Transition Dyspnoea Index (TDI) Focal Score at Week 24
The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 ("major deterioration") to zero ("no change") to +3 ("major improvement"). Category scores are added to compute the Focal Score (from -9 to 9)
Time frame: At Week 24
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Almirall Investigational Site
Feldbach, Austria
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Feldkirch, Austria
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Grieskirchen, Austria
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Linz, Austria
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Salzburg, Austria
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Dimitrovgrad, Bulgaria
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Gabrovo, Bulgaria
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Kozloduy, Bulgaria
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Petrich, Bulgaria
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Plovdiv, Bulgaria
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