A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00244608

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Budesonide/Formoterol Turbuhaler Drug: Budesonide Turbuhaler (Pulmicort) Drug: Terbutaline Turbuhaler	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS

Study Start Date :

May 1, 2005

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period) []

Secondary Outcome Measures

Immunopathology and remodeling in biopsies []
Immunopathology and mediators in induced sputum []
Severe asthma exacerbations (number of and time to first) []
Forced expiratory volume in 1 second (FEV1) []
As-needed use []
Safety variables, including adverse events and vital signs []
All variables assessed over the 12-month treatment period []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of asthma for at least 6 months
Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one

Exclusion Criteria:

Respiratory infection affecting asthma within 30 days prior to study
Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
Any significant disease or disorder that may jeopardize the safety of the patient

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Copenhagen	Denmark
2	Research Site	Ålborg	Denmark
3	Research Site	Århus C	Denmark
4	Research Site	Montpellier	France
5	Research Site	Pessac	France
6	Research Site	Hannover	Germany
7	Research Site	Mainz	Germany
8	Research Site	Marburg	Germany
9	Research Site	Baraclado	Spain
10	Research Site	Barcelona No. 40	Spain
11	Research Site	Barcelona, No. 42	Spain
12	Research Site	Göteborg	Sweden
13	Research Site	Lund	Sweden
14	Research Site	Stockholm	Sweden
15	Research Site	Umeå	Sweden
16	Research Site	Uppsala	Sweden
17	Research Site	Glasgow	United Kingdom
18	Research Site	Leicester	United Kingdom
19	Research Site	London	United Kingdom
20	Research Site	Manchester	United Kingdom
21	Research Site	Newcastle-Upon-Tyne	United Kingdom
22	Research Site	Southampton	United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: AstraZeneca Symbicort Medical Science Director, MD, AstraZeneca

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00244608

Other Study ID Numbers:

D5890C00003
EudraCT no. 2004-004042-41

First Posted:

Oct 27, 2005

Last Update Posted:

Jan 24, 2011

Last Verified:

Jan 1, 2011

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2011