Study identifier:M/273FO/23
ClinicalTrials.gov identifier:NCT00626522
EudraCT identifier:2007-004435-30
CTIS identifier:N/A
A randomised, 4-week, placebo-controlled, double-blind, 6 arm parallel group, dose-finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three different doses of formoterol combined with the inhaled anticholinergic aclidinium bromide, aclidinium bromide monotherapy and formoterol monotherapy all administrated once daily by inhalation via almirall inhaler in patients with stable moderate to severe chronic obstructive pulmonary disease.
Chronic obstructive pulmonary disease (COPD)
Phase 2
No
Aclidinium bromide and formoterol, Aclidinium bromide and formoterol placebo
All
808
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 | Drug: Aclidinium bromide and formoterol once daily |
Experimental: 2 | Drug: Aclidinium bromide and formoterol once daily |
Experimental: 3 | Drug: Aclidinium bromide and formoterol once daily |
Placebo Comparator: 4 | Drug: Aclidinium bromide and formoterol placebo once daily |
Placebo Comparator: 5 | Drug: Aclidinium bromide and formoterol placebo once daily |
Placebo Comparator: 6 | Drug: Aclidinium bromide and formoterol placebo once daily |