Phase4/Symbicort® versus Pulmicort Flexhaler® in African Americans - Titan

Study identifier:D589BL00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A 12-wk, rand., double-blind, double dummy, multi-ctr., phase IV study comparing efficacy and safety of SYMBICORT® pMDI 160/4.5 ug x 2 actuations twice daily versus Pulmicort® (budesonide inhalation powder DPI) 180 ug x 2 inhalations twice daily, in adult and adolescent African American subjects with asthma

Medical condition

asthma

Phase

Phase 4

Healthy volunteers

No

Study drug

Budesonide / formoterol fumarate (SYMBICORT), Budesonide

Sex

All

Actual enrollment

311

Study type

Interventional

Age

12 Years +

Date

Study Start Date: 01 Jun 2008
Primary Completion Date: 01 Sept 2009
Study Completion Date: 01 Sept 2009

Study design

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

Verification:

Verified 01 Oct 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria