A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®

This study has been completed.
Sponsor:
Collaborator:
CLINRESEARCH GMBH
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00884689
First received: April 20, 2009
Last updated: March 30, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART® 1-2 Inhalations b.i.d. as Maintenance Therapy Plus Additional Inhalations As-needed, Compared to Patients Treated With a Free Combination of an Inhaled Glucocorticosteroid and an Inhaled Long Acting ß2-agonist Plus as Needed Inhalations of a Short Acting ß2 Agonist.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Use of rescue medication [ Time Frame: daily during 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 3 times during study ] [ Designated as safety issue: No ]
  • Efficacy variables [ Time Frame: during 6 month ] [ Designated as safety issue: No ]
  • Safety variables [ Time Frame: during 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2009
Study Completion Date: June 2010
Groups/Cohorts
1
Asthma patient with specific treatment
2
Asthma patient on different specific treatment compared to the other group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asthma treatment will not be assigned randomly, but will be administered at the discretion of the physicians according to standard medical practice. Each site should enrol 5 patients using the Symbicort® SMART® principle and 5 patients being prescribed a free combination GCS / LABA treatment.

Criteria

Inclusion Criteria:

  • Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1.
  • Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
  • A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit 1.
  • A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:

    • Oral/systemic GCS treatment due to asthma for at least 3 days
    • Unscheduled health-care visit due to asthmaHospitalization or emergency room visit because of asthma requiring treatment with oral/systemic GCS

Exclusion Criteria:

  • Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
  • Use of ß-blocking agents
  • Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.
  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: NCT00884689

Locations
Germany
Research Site
Aschaffenburg, Germany
Research Site
Bad Lippspringe, Germany
Research Site
Bad Sassendorf, Germany
Research Site
Bergkamen, Germany
Research Site
Berlin, Germany
Research Site
Bochum, Germany
Research Site
Bonn, Germany
Research Site
Braunschweig, Germany
Research Site
Buchholz, Germany
Research Site
Chemnitz, Germany
Research Site
Coswig, Germany
Research Site
Cottbus, Germany
Research Site
Dortmund, Germany
Research Site
Dresden, Germany
Research Site
Dusseldorf, Germany
Research Site
Frankfurt, Germany
Research Site
Furth, Germany
Research Site
Gelsenkirchen, Germany
Research Site
Gutersloh, Germany
Research Site
Halle, Germany
Research Site
Hamburg, Germany
Research Site
Ketzin, Germany
Research Site
Kothen, Germany
Research Site
Leipzig, Germany
Research Site
Lohne, Germany
Research Site
Lubeck, Germany
Research Site
Ludenscheid, Germany
Research Site
Marburg, Germany
Research Site
Marl, Germany
Research Site
Mittelbach, Germany
Research Site
Muhlhausen, Germany
Research Site
Mulheim, Germany
Research Site
Munchen, Germany
Research Site
Oschersleben, Germany
Research Site
Potsdam, Germany
Research Site
Remscheid, Germany
Research Site
Saarlouis, Germany
Research Site
Schwetzingen, Germany
Research Site
Steinhagen, Germany
Research Site
Stockach, Germany
Research Site
Wedel, Germany
Research Site
Wesseling, Germany
Research Site
Weyhe, Germany
Sponsors and Collaborators
AstraZeneca
CLINRESEARCH GMBH
Investigators
Study Director: Kai Richter, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Dr. Kai Richter, Vice President Medical
ClinicalTrials.gov Identifier: NCT00884689     History of Changes
Other Study ID Numbers: NIS-RDE-SYM-2009/1
Study First Received: April 20, 2009
Last Updated: March 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
Symbicort SMART
Free Combination GCS/LABA treatment

Additional relevant MeSH terms:
Symbicort
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014