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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00259792
First received: November 29, 2005
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Budesonide/formoterol Turbuhaler
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to first severe asthma exacerbation

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1000
Study Start Date: September 2004
Study Completion Date: January 2006
Intervention Details:
    Drug: Budesonide/formoterol Turbuhaler
    Other Name: Symbicort
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259792

  Hide Study Locations
Locations
France
Research Site
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 Sites
Creteil, France
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00259792     History of Changes
Other Study ID Numbers: D5890L00005, SYMPHONIE
Study First Received: November 29, 2005
Last Updated: January 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014