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.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00259792

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 III

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Symbicort

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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 2005

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

Show 82 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca France Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	D5890L00005, SYMPHONIE
Study First Received:	November 29, 2005
Last Updated:	December 6, 2006
ClinicalTrials.gov Identifier:	NCT00259792
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases
Lung Diseases

Budesonide
Hypersensitivity, Immediate
Formoterol
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases

Therapeutic Uses
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009