Efficacy and safety of two fixed dose combinations of aclidinium bromide with formoterol fumarate - ALIGHT-COPD

Study identifier:M/40464/26

ClinicalTrials.gov identifier:NCT01078623

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Efficacy, safety and tolerability of two Fixed-Dose Combinations of Aclidinium bromide with two doses of Formoterol fumarate compared with Aclidinium bromide, Formoterol fumarate and placebo all administered twice daily in stable, moderate to severe Chronic Obstructive Pulmonary Disease patients.

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 2

Healthy volunteers

No

Study drug

Aclidinium 200 μg / formoterol 12 μg, Placebo, Formoterol 12 μg, Aclidinium 200 μg, Aclidinium 200 μg / Formoterol 6 μg

Sex

All

Actual Enrollment

176

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Feb 2010
Primary Completion Date: 01 Sept 2010
Study Completion Date: 01 Sept 2010

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Dec 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria