Aclidinium/Formoterol Fixed Combination Dose finding Study

Study identifier:M/273FO/23

ClinicalTrials.gov identifier:NCT00626522

EudraCT identifier:2007-004435-30

CTIS identifier:N/A

Study Complete

Official Title

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.

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

No

Study drug

Aclidinium bromide and formoterol, Aclidinium bromide and formoterol, Aclidinium bromide and formoterol, Aclidinium bromide and formoterol placebo, Aclidinium bromide and formoterol placebo, Aclidinium bromide and formoterol placebo

Sex

All

Actual enrollment

808

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Feb 2008
Primary Completion Date: 01 Nov 2008
Study Completion Date: 01 Nov 2008

Study design

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

Verification:

Verified 01 Sept 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria