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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259792
• Other study ID #: D5890L00005
• Secondary ID: SYMPHONIE
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2005
• Last updated: January 21, 2011
• Start date: September 2004
• Est. completion date: January 2006

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/formoterol Turbuhaler

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first severe asthma exacerbation
Secondary	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