A comparison of Symbicort® pMDI 2 x 160/4.5 μg bid and Symbicort® pMDI 2 x 80/4.5 μg bid with formoterol Turbuhaler®, budesonide pMDI, the combination of formoterol Turbuhaler® and budesonide pMDI, and placebo in COPD Patients

Study identifier:D5899C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 6-Month Double-blind, Double-dummy, Randomized, Parallel group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg bid Compared to Formoterol TBH, Budesonide pMDI (& the combination) & Placebo in COPD Patients

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 3

Healthy volunteers

No

Study drug

-

Sex

All

Actual Enrollment

1500

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Apr 2005
Primary Completion Date: -
Study Completion Date: 01 Dec 2006

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria