We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy (RELEASE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00319306
First Posted: April 27, 2006
Last Update Posted: March 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.

Condition Intervention Phase
Asthma Drug: Budesonide/formoterol Device: Symbicort® Turbohaler® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients.

Secondary Outcome Measures:
  • Change in forced expiratory volume in one second (FEV1)
  • Change in peak expiratory flow (PEF)
  • Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores

Estimated Enrollment: 550
Study Start Date: September 2005
Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged over 18
  • Confirmed diagnosis of mild to moderate asthma by doctor
  • Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment

Exclusion Criteria:

  • Women who are pregnant, breast-feeding, or planning pregnancy
  • Patients with a history of chronic obstructive pulmonary disease
  • Patients using any beta blocker therapy
  • Patients receiving steroid tablets or steroid injections
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319306


  Show 59 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Iain Small, MD General Practitioner
Study Director: AstraZeneca UK Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00319306     History of Changes
Other Study ID Numbers: D5890L00012
RELEASE
First Submitted: April 27, 2006
First Posted: April 27, 2006
Last Update Posted: March 17, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Respiratory Tract Diseases
Bronchial Diseases
Anti-asthmatic agents
Anti-asthmatic drugs
Bronchodilators

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