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A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice

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.
 
ClinicalTrials.gov Identifier: NCT00505388
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : January 18, 2020
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date July 17, 2007
First Posted Date July 23, 2007
Last Update Posted Date January 18, 2020
Study Start Date July 2007
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice
Official Title A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice
Brief Summary This patient follow-up programme was designed to describe the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy in routine clinical practice in comparison with the already documented use of Symbicort as maintenance and reliever therapy in clinical therapies
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patients continued with their treatment (Symbicort SMART) after enrolment. Enrolment throug IVRS/IWRS, no randomisation. Primary care clinic.
Condition Bronchial Asthma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Stallberg B, Naya I, Ekelund J, Eckerwall G. Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy. Int J Clin Pharmacol Ther. 2015 Jun;53(6):447-55. doi: 10.5414/CP202224.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 23, 2010)		 5137
Original Estimated Enrollment
 (submitted: July 20, 2007)		 8000
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this programme
  • signed and dated informed consent(ICF)
  • for patients under-age, signed and dated ICF form from both the patient and the patient's parent/legal guardian is required

Exclusion Criteria:

  • Involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Bulgaria,   Czechia,   Denmark,   Germany,   Greece,   Hungary,   Netherlands,   Norway,   Portugal,   Sweden,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT00505388
Other Study ID Numbers D5890C00018
EuDract 2006-005677-22
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party Not Provided
Current Study Sponsor AstraZeneca
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Tomas Andersson, MD AstraZeneca
Principal Investigator: Bjorn Stallberg, MD Trosa Vardcentral
PRS Account AstraZeneca
Verification Date April 2010