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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00505388
First received: July 17, 2007
Last updated: April 23, 2010
Last verified: April 2010
  Purpose
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

Condition
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

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)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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)
  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 ClinicalTrials.gov identifier: NCT00505388

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov 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:
asthma
bronchial
Symbicort

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 26, 2016