Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 17, 2007
Last updated: April 23, 2010
Last verified: April 2010

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

Bronchial Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Enrollment: 5137
Study Start Date: July 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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)
  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: NCT00505388

  Show 703 Study Locations
Sponsors and Collaborators
Study Director: Tomas Andersson, MD AstraZeneca
Principal Investigator: Bjorn Stallberg, MD Trosa Vardcentral
  More Information

No publications provided

Responsible Party: AstraZeneca Identifier: NCT00505388     History of Changes
Other Study ID Numbers: D5890C00018, EuDract 2006-005677-22
Study First Received: July 17, 2007
Last Updated: April 23, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Symbicort processed this record on February 27, 2015