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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: April 27, 2006
Last updated: March 16, 2009
Last verified: March 2009
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

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

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
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 identifier: NCT00319306

  Show 59 Study Locations
Sponsors and Collaborators
Principal Investigator: Iain Small, MD General Practitioner
Study Director: AstraZeneca UK Medical Director, MD AstraZeneca
  More Information Identifier: NCT00319306     History of Changes
Other Study ID Numbers: D5890L00012
Study First Received: April 27, 2006
Last Updated: March 16, 2009

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
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
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 21, 2017