SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults

January 21, 2011 updated by: AstraZeneca

A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, Parallel Group Multicentre Study

The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1000

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

  • France
      • Abbeville, France
        • Research Site
      • Agen, France
        • Research Site
      • Ajaccio, France
        • Research Site
      • Albi, France
        • Research Site
      • Ales, France
        • Research Site
      • Amberieu En Bugey, France
        • Research Site
      • Amiens, France
        • Research Site
      • Angers, France
        • Research Site
      • Angouleme, France
        • Research Site
      • Apt, France
        • Research Site
      • Arles, France
        • Research Site
      • Aubagne, France
        • Research Site
      • Avignon, France
        • Research Site
      • Avrille, France
        • Research Site
      • Bastia, France
        • Research Site
      • Bayonne, France
        • Research Site
      • Bethune, France
        • Research Site
      • Beziers, France
        • Research Site
      • Biarritz, France
        • Research Site
      • Blois, France
        • Research Site
      • Bois Guillaume, France
        • Research Site
      • Bordeaux, France
        • Research Site
      • Boulogne Billancourt, France
        • Research Site
      • Bourgoin Jallieu, France
        • Research Site
      • Brest, France
        • Research Site
      • Briey, France
        • Research Site
      • Bron, France
        • Research Site
      • Cabestany, France
        • Research Site
      • Cachan, France
        • Research Site
      • Caen, France
        • Research Site
      • Cagnes Sur Mer, France
        • Research Site
      • Cambrai, France
        • Research Site
      • Carcassonne, France
        • Research Site
      • Castelnau Le Lez, France
        • Research Site
      • Challans, France
        • Research Site
      • Chalons En Champagne, France
        • Research Site
      • Champs Sur Marne, France
        • Research Site
      • Charleville Mezieres, France
        • Research Site
      • Chelles, France
        • Research Site
      • Cherbourg Octeville, France
        • Research Site
      • Chevilly Larue, France
        • Research Site
      • Choisy Le Roi, France
        • Research Site
      • Cholet, France
        • Research Site
      • Colmar, France
        • Research Site
      • Cornebarrieu, France
        • Research Site
      • Courbevoie, France
        • Research Site
      • Creteil, France
        • Research Sites
      • Denain, France
        • Research Site
      • Dieppe, France
        • Research Site
      • Dijon, France
        • Research Site
      • Dole, France
        • Research Site
      • Epernay, France
        • Research Site
      • Epinal, France
        • Research Site
      • Ermont, France
        • Research Site
      • Etampes, France
        • Research Site
      • Fecamp, France
        • Research Site
      • Forbach, France
        • Research Site
      • Gournay Sur Marne, France
        • Research Site
      • Grenoble, France
        • Research Site
      • Hagondange, France
        • Research Site
      • Hazebrouck, France
        • Research Site
      • Henin Beaumont, France
        • Research Site
      • Herblay, France
        • Research Site
      • Hyeres, France
        • Research Site
      • Issy Les Moulineaux, France
        • Research Site
      • Joigny, France
        • Research Site
      • Juan Les Pins, France
        • Research Site
      • La Roche Sur Yon, France
        • Research Site
      • La Rochelle, France
        • Research Site
      • La Teste De Buch, France
        • Research Site
      • Lagardelle Sur Leze, France
        • Research Site
      • Le Havre, France
        • Research Site
      • Le Puy En Velay, France
        • Research Site
      • Lens, France
        • Research Site
      • Les Mureaux, France
        • Research Site
      • Libourne, France
        • Research Site
      • Lille, France
        • Research Site
      • Limoges, France
        • Research Site
      • Loudeac, France
        • Research Site
      • Luneville, France
        • Research Site
      • Lyon, France
        • Research Site
      • Marcq En Baroeul, France
        • 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.

Exclusion Criteria:

  • Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to first severe asthma exacerbation

Secondary Outcome Measures

Outcome Measure
Number of asthma exacerbations, Mean use of as-needed medication, Prescribed asthma medication, Asthma Control Questionnaire, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events

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

September 1, 2004

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

November 29, 2005

First Submitted That Met QC Criteria

November 29, 2005

First Posted (Estimate)

December 1, 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

  • D5890L00005
  • SYMPHONIE

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.

Clinical Trials on Asthma

Clinical Trials on Budesonide/formoterol Turbuhaler

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe