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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 : April 26, 2010
Sponsor:
Information provided by:

Study Description
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

Condition or disease
Bronchial Asthma

Study Design

Study Type : Observational
Actual Enrollment : 5137 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice
Study Start Date : July 2007
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: April 26, 2010
Last Verified: April 2010

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