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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252824
First received: November 10, 2005
Last updated: January 21, 2011
Last verified: January 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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
Intervention Details:
    Drug: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy
    Other Name: Symbicort
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00252824     History of Changes
Other Study ID Numbers: D5890L00014, STYLE
Study First Received: November 10, 2005
Last Updated: January 21, 2011
Health Authority: Portugal: National Pharmacy and Medicines Institute

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014