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

NCT ID: NCT00259792

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Budesonide/formoterol Turbuhaler

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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).
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca France Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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France

Other Identifiers

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SYMPHONIE

Identifier Type: -

Identifier Source: secondary_id

D5890L00005

Identifier Type: -

Identifier Source: org_study_id

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