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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00319306
First received: April 27, 2006
Last updated: March 16, 2009
Last verified: March 2009

April 27, 2006
March 16, 2009
September 2005
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00319306 on ClinicalTrials.gov Archive Site
  • Change in forced expiratory volume in one second (FEV1)
  • Change in peak expiratory flow (PEF)
  • Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores
Same as current
Not Provided
Not Provided
 
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Budesonide/formoterol
  • Device: Symbicort® Turbohaler®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
December 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00319306
D5890L00012, RELEASE
Not Provided
Not Provided
AstraZeneca
Not Provided
Principal Investigator: Iain Small, MD General Practitioner
Study Director: AstraZeneca UK Medical Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP