STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00252824

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 vs Conventional Best Asthma Therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus as-Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-Label, Parallel-Group, Multicentre Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Formoterol Symbicort

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
Asthma Control Questionnaire
Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)
Safety: Serious Adverse Events and discontinuations due to adverse events
All variables assessed over the 6 months treatment period

Estimated Enrollment:	1000
Study Start Date:	July 2005
Study Completion Date:	December 2006

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 3 months
Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day 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: NCT00252824

Show 53 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D5890L00014, STYLE
Study First Received:	November 10, 2005
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00252824 History of Changes
Health Authority:	Portugal: National Pharmacy and Medicines Institute

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Symbicort
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010