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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

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
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

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Sears MR, Boulet LP, Laviolette M, Fitzgerald JM, Bai TR, Kaplan A, Smiljanic-Georgijev N, Lee JS. Budesonide/formoterol maintenance and reliever therapy: impact on airway inflammation in asthma. Eur Respir J. 2008 May;31(5):982-9. Epub 2008 Jan 23.

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010