Efficacy & safety of Symbicort® TURBUHALER® 160/4.5 µg twice daily & Pulmicort® TURBUHALER® 200 µg twice daily + Theolong® tablet 200 mg twice daily in Japanese asthmatic patients

Study identifier:D5890C00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An 8-week, randomised, double blind, parallel-group, multi-centre, phase III study comparing the efficacy and safety of Symbicort® Turbuhaler® 160/4.5 µg twice daily and Pulmicort® Turbuhaler® 200 µg twice daily + Theolong® tablet 200 mg twice daily in Japanese patients with asthma

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

No

Study drug

Budesonide/Formoterol, Budesonide, Theophylline

Sex

All

Actual Enrollment

340

Study type

Interventional

Age

16 Years +

Date

Study Start Date: 01 Oct 2005
Primary Completion Date: -
Study Completion Date: 01 Nov 2006

Study design

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

Verification:

Verified 01 Jan 2011 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria