Efficacy and safety of three doses of aclidinium bromide compared to placebo and to an active comparator in Chronic Obstructive Pulmonary Disease (COPD) patients.

Study identifier:M/34273/29

ClinicalTrials.gov identifier:NCT01120093

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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).

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

No

Study drug

Aclidinium bromide 100 μg bid, Aclidinium bromide 200 μg bid, Aclidininum bromide 400 μg bid, Placebo, Formoterol 12 μg bid

Sex

All

Actual Enrollment

79

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 May 2010
Primary Completion Date: 01 Aug 2010
Study Completion Date: 01 Aug 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria