Clinical trial NCT00259792: SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Time to first severe asthma exacerbation
Secondary outcomes:
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
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Research Site
city: Agen
country: France
facility: Research Site
city: Ajaccio
country: France
facility: Research Site
city: Albi
country: France
facility: Research Site
city: Ales
country: France
facility: Research Site
city: Amberieu En Bugey
country: France
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Angers
country: France
facility: Research Site
city: Angouleme
country: France
facility: Research Site
city: Apt
country: France
facility: Research Site
city: Arles
country: France
facility: Research Site
city: Aubagne
country: France
facility: Research Site
city: Avignon
country: France
facility: Research site
city: Avrille
country: France
facility: Research Site
city: Bastia
country: France
facility: Research Site
city: Bayonne
country: France
facility: Research Site
city: Bethune
country: France
facility: Research Site
city: Beziers
country: France
facility: Research Site
city: Biarritz
country: France
facility: Research Site
city: Blois
country: France
facility: Research Site
city: Bois Guillaume
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Boulogne Billancourt
country: France
facility: Research Site
city: Bourgoin Jallieu
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Briey
country: France
facility: Research Site
city: Bron
country: France
facility: Research Site
city: Cabestany
country: France
facility: Research Site
city: Cachan
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Cagnes Sur Mer
country: France
facility: Research Site
city: Cambrai
country: France
facility: Research Site
city: Carcassonne
country: France
facility: Research Site
city: Castelnau Le Lez
country: France
facility: Research Site
city: Challans
country: France
facility: Research site
city: Chalons En Champagne
country: France
facility: Research Site
city: Champs Sur Marne
country: France
facility: Research Site
city: Charleville Mezieres
country: France
facility: Research Site
city: Chelles
country: France
facility: Research Site
city: Cherbourg Octeville
country: France
facility: Research Site
city: Chevilly Larue
country: France
facility: Research Site
city: Choisy Le Roi
country: France
facility: Research Site
city: Cholet
country: France
facility: Research site
city: Colmar
country: France
facility: Research Site
city: Cornebarrieu
country: France
facility: Research Site
city: Courbevoie
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Sites
city: Denain
country: France
facility: Research Site
city: Dieppe
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Dole
country: France
facility: Research Site
city: Epernay
country: France
facility: Research Site
city: Epinal
country: France
facility: Research Site
city: Ermont
country: France
facility: Research Site
city: Etampes
country: France
facility: Research Site
city: Fecamp
country: France
facility: Research Site
city: Forbach
country: France
facility: Research Site
city: Gournay Sur Marne
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: Hagondange
country: France
facility: Research Site
city: Hazebrouck
country: France
facility: Research Site
city: Henin Beaumont
country: France
facility: Research Site
city: Herblay
country: France
facility: Research Site
city: Hyeres
country: France
facility: Research Site
city: Issy Les Moulineaux
country: France
facility: Research Site
city: Joigny
country: France
facility: Research Site
city: Juan Les Pins
country: France
facility: Research Site
city: La Roche Sur Yon
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research site
city: La Teste De Buch
country: France
facility: Research Site
city: Lagardelle Sur Leze
country: France
facility: Research Site
city: Le Havre
country: France
facility: Research Site
city: Le Puy En Velay
country: France
facility: Research Site
city: Lens
country: France
facility: Research site
city: Les Mureaux
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Limoges
country: France
facility: Research site
city: Loudeac
country: France
facility: Research site
city: Luneville
country: France
facility: Research site
city: Lyon
country: France
facility: Research Site
city: Marcq En Baroeul
country: France
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director, MD
role: STUDY_DIRECTOR
References: