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

January 21, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Research Site
      • Ålborg, Denmark
        • Research Site
      • Århus C, Denmark
        • Research Site
  • France
      • Montpellier, France
        • Research Site
      • Pessac, France
        • Research Site
  • Germany
      • Hannover, Germany
        • Research Site
      • Mainz, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
  • Spain
      • Baraclado, Spain
        • Research Site
      • Barcelona No. 40, Spain
        • Research Site
      • Barcelona, No. 42, Spain
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Umeå, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Research Site
      • Leicester, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Newcastle-Upon-Tyne, United Kingdom
        • Research Site
      • Southampton, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (Estimate)

October 27, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890C00003
  • EudraCT no. 2004-004042-41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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