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
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 April 17, 2014