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Clinical trial

Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

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Last updated:1st Oct 2011
Identifier: NCT01462942

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
Allocation: Randomized
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.
Enrollment: 2443
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Arms:
- 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


Related journal:
- Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol.

Category Value
Date last updated at source 2017-02-15
Study type(s) Interventional
Expected enrolment 2443
Study start date 2011-10-01
Estimated primary completion date 2013-01-01

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