Evaluation of efficacy and safety of formoterol in patients with COPD compared with placebo in patients in Japan, EU - OCEAN

Study identifier:D5122C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 12-week, randomised, double-blind, placebo-controlled, parallel-group, multi-national, phase III, efficacy and safety study of inhaled formoterol 4.5 μg and 9 μg twice daily in Japanese and European patients with chronic obstructive pulmonary disease (COPD)

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Formoterol Turbuhaler® 4.5mg, Formoterol Turbuhaler® 9 mg, Turbuhaler® placebo

Sex

All

Actual Enrollment

613

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Dec 2007
Primary Completion Date: 01 Apr 2009
Study Completion Date: 01 Apr 2009

Study design

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

Verification:

Verified 01 Sept 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria