The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
Study Type: Interventional
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
- Experimental: Aclidinium/Formoterol 400/6 μg
- Experimental: Aclidinium/Formoterol 400/12 μg
- Experimental: Aclidinium monotherapy 400 μg
- Active Comparator: Formoterol monotherapy 12 μg
- Placebo Comparator: Placebo
- Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol.
|Date last updated at source||2017-02-15|
|Study start date||2011-10-01|
|Estimated primary completion date||2013-01-01|