Symbicort Usage in Asthma Treatment and Impact of a New Therapeutic Strategy on Compliance and Asthma Control in France (SYMBIOSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00812357
First received: December 19, 2008
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Descriptive Pharmacoepidemiological Study on the Use of Symbicort Turbuhaler in the Treatment of Asthma in France and Impact of a New Therapeutic Strategy on the Compliance and Control of Asthma

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Level of control of the asthma [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Evaluation of compliance with treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 579
Study Start Date: April 2009
Study Completion Date: August 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients treated with Symbicort basic treatment
2
Patients treated with Symbicort basic treatment + treatment of symptoms as needed

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • Asthmatic patients treated for this disease with Symbicort Turbuhaler
  • Patients monitored for asthma by the doctor for at least 12 months
  • Patients seen in outpatient care at the baseline visit
  • Patients agreeing to participate in the study

Exclusion Criteria:

  • Patients with any chronic lower respiratory disease other than asthma
  • Patients receiving anti-IgE agents in the last 4 months
  • Patients receiving desensitisation treatment outside of the maintenance phase
  • Patients deemed to be unable to respond to the study for linguistic or cognitive reasons
  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: NCT00812357

  Show 175 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Stephane SCHÜCK, MD, MSc KAPPA SANTE - Paris - France
Study Chair: Michel AUBIER, MD, Professor CHU Bichat - Service de pneumologie - Paris - France
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00812357     History of Changes
Other Study ID Numbers: NIS-RFR-SYM-2008/1
Study First Received: December 19, 2008
Last Updated: December 27, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Haute Autorité de Santé Transparency Commission

Keywords provided by AstraZeneca:
Symbicort Turbuhaler
asthma
cohort study
France

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Symbicort
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014