SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00238784

Purpose

The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice 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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of Symbicort® Single Inhaler Therapy (Symbicort® 200 Turbuhaler® 1 Inhalation b.i.d. Plus as Needed) & Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents & Adults-a 26-Week, Randomised, Open-Label, Parallel Group, Multicentre Study

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Secondary Outcome Measures:

Number of asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Patient reported Outcomes
Health care resource use
Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events
Induced sputum will be sampled from a subset of patients
All variables assessed over the 6 months treatment period

Estimated Enrollment:	1300
Study Start Date:	May 2004
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Diagnosis of asthma < 3 months
Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria:

Smoking history > 10 pack-years
Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
Any significant disease or disorder that my jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238784

Locations

Canada, British Columbia
Research Site
Aldergrove, British Columbia, Canada
Canada, Ontario
Research Site
Bolton, Ontario, Canada
Research Site
Brampton, Ontario, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Rita Medical Science Director, MD

AstraZeneca

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Study ID Numbers:	D5890L00004, SOLO
Study First Received:	October 12, 2005
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00238784
Health Authority:	United States: Food and Drug Administration

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