SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults
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
2 other identifiers
interventional
1,000
1 country
82
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Sep 2004
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 29, 2005
CompletedFirst Posted
Study publicly available on registry
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedJanuary 24, 2011
January 1, 2011
November 29, 2005
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first severe asthma exacerbation
Secondary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (82)
Research Site
Abbeville, France
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Agen, France
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Ajaccio, France
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Albi, France
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Alès, France
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Ambérieu-en-Bugey, France
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Amiens, France
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Angers, France
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Angoulême, France
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Apt, France
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Arles, France
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Aubagne, France
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Avignon, France
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Avrillé, France
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Bastia, France
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Bayonne, France
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Béthune, France
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Béziers, France
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Biarritz, France
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Blois, France
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Bois-Guillaume, France
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Bordeaux, France
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Boulogne-Billancourt, France
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Bourgoin, France
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Brest, France
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Briey, France
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Bron, France
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Cabestany, France
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Cachan, France
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Caen, France
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Cagnes-sur-Mer, France
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Cambrai, France
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Carcassonne, France
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Castelnau-le-Lez, France
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Challans, France
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Champs-sur-Marne, France
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Charleville-Mézières, France
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Châlons-en-Champagne, France
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Chelles, France
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Cherbourg Octeville, France
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Chevilly-Larue, France
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Choisy-le-Roi, France
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Cholet, France
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Colmar, France
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Cornebarrieu, France
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Courbevoie, France
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Créteil, France
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Denain, France
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Dieppe, France
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Dijon, France
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Dole, France
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Ermont, France
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Épernay, France
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Épinal, France
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Étampes, France
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Fécamp, France
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Forbach, France
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Gournay-sur-Marne, France
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Grenoble, France
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Hagondange, France
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Hazebrouck, France
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Herblay-sur-Seine, France
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Hénin-Beaumont, France
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Hyères, France
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Issy-les-Moulineaux, France
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Joigny, France
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Juan-les-Pins, France
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La Roche-sur-Yon, France
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La Rochelle, France
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La Teste-de-Buch, France
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Lagardelle-sur-Lèze, France
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Le Havre, France
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Le Puy-en-Velay, France
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Lens, France
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Les Mureaux, France
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Libourne, France
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Lille, France
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Limoges, France
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Loudéac, France
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Lunéville, France
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Lyon, France
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Marcq-en-Barœul, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca France Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 29, 2005
First Posted
December 1, 2005
Study Start
September 1, 2004
Study Completion
January 1, 2006
Last Updated
January 24, 2011
Record last verified: 2011-01