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

Tracking Information

First Received Date ^ICMJE

October 25, 2005

Last Updated Date

March 10, 2009

Start Date ^ICMJE

May 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00244608 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Immunopathology and remodeling in biopsies
Immunopathology and mediators in induced sputum
Severe asthma exacerbations (number of and time to first)
FEV1
As-needed use
Safety variables, including adverse events and vital signs
- all variables assessed over the 12 months treatment period

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Budesonide/Formoterol Turbuhaler (Symbicort)
Drug: Budesonide Turbuhaler (Pulmicort)
Drug: Terbutaline Turbuhaler

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark, France, Germany, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00244608

Responsible Party

Study ID Numbers ^ICMJE

D5890C00003, EudraCT no. 2004-004042-41

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP