The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 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
79
Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
Placebo via inhalation in the morning and evening for 7 days
Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days
Almirall Investigational Sites#1
Ghent, Belgium
Almirall Investigational Sites#3
Berlin, Germany
Almirall Investigational Sites#4
Berlin, Germany
Almirall Investigational Sites#9
Berlin, Germany
Almirall Investigational Sites#8
Frankfurt, Germany
Almirall Investigational Sites#1
Groβhansdorf, Germany
Almirall Investigational Sites#5
Hamburg, Germany
Almirall Investigational Sites#7
Hanover, Germany
Almirall Investigational Sites#2
Hanover, Germany
Almirall Investigational Sites#6
Schwerin, Germany
...and 1 more locations
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment
Time frame: Day 7
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 12-24h at Day 7 on Treatment
Time frame: Day 7
Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-24h at Day 7 on Treatment
Time frame: Day 7
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in First Second (FEV1) at Day 7 on Treatment
Time frame: Day 7
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