Efficacy and safety study of Symbicort® Turbuhaler® versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) patients - SUMIRE

Study identifier:D589DC00007

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase III, 12-week, double-blind, randomised, parallel-group, active-controlled, multinational, efficacy and safety study of Symbicort® Turbuhaler® 160/4.5 μg 2 inhalations twice daily (bid) compared to Oxis® Turbuhaler® 4.5 μg 2 inhalations twice daily (bid) in patients with chronic obstructive pulmonary disease

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

Budesonide/formoterol (Symbicort Turbuhaler), Formoterol (Oxis Turbuhaler)

Sex

All

Actual Enrollment

1293

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Jan 2010
Primary Completion Date: 01 Mar 2011
Study Completion Date: 01 Mar 2011

Study design

Allocation: Randomized
Endpoint Classification: 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