Study identifier:M/34273/29
ClinicalTrials.gov identifier:NCT01120093
EudraCT identifier:N/A
CTIS identifier:N/A
Efficacy and safety of three doses of aclidinium bromide compared to placebo and to an active comparator all administered twice daily by inhalation in patients with stable moderate and severe chronic obstructive pulmonary disease (COPD).
Chronic obstructive pulmonary disease (COPD)
Phase 2
No
Aclidinium bromide 100 μg bid, Aclidinium bromide 200 μg bid, Aclidininum bromide 400 μg bid, Placebo, Formoterol 12 μg bid
All
79
Interventional
40 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Aclidinium bromide 100 μg bid Aclidininum bromide 100 μg twice daily by inhalation | Drug: Aclidinium bromide 100 μg bid Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
Experimental: Aclidininum bromide 200 μg bid Aclidininum bromide 200 μg twice daily by inhalation | Drug: Aclidinium bromide 200 μg bid Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
Experimental: Aclidininum bromide 400 μg bid Aclidininum bromide 400 μg twice daily by inhalation | Drug: Aclidininum bromide 400 μg bid Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days |
Placebo Comparator: Placebo Placebo twice-daily by inhalation | Drug: Placebo Placebo via inhalation in the morning and evening for 7 days |
Active Comparator: Formoterol 12 μg bid Formoterol 12 μg twice daily by inhalation | Drug: Formoterol 12 μg bid Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days |