The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there is a 7-days wash-out period in between them. The trial starts with a run in phase of 10 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
176
Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
Placebo control twice daily
Formoterol fumarate 12 μg twice daily
Research Site
Bucuresti, Czechia
Research Site
Constanta, Czechia
Research Site
Iasi, Czechia
Research Site
Tg Mures, Czechia
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over 12 Hours (AUC0-12h) After Morning Study Drug Administration at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
Time frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
Change From Baseline in Morning Pre-dose FEV1 at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes
Time frame: Day 14
Change From Baseline in Morning Peak FEV1 at Day 14
FEV1 was measured via spirometry: 2 sets of tests prior to morning dose separated by 30 minutes, and then 1 set at 30 minutes, 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose
Time frame: 0 and 30 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post-morning dose at Day 14
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Aclidinium bromide 200 μg twice daily
Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Deva, Romania
Research Site
Iași, Romania
Research Site
Oradea, Romania
Research Site
Timișoara, Romania