Symbicort in Chronic Obstruktive Pulmonary Disease (SYMBIOSE)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00612976
First received: January 30, 2008
Last updated: February 11, 2008
Last verified: January 2008
  Purpose

Under daily routine conditions and without any intervention by the sponsor regarding the selection of subjects, diagnostic procedures, therapeutic decisions (medicinal and non- medicinal therapy, dose, duration, etc.), routine assessments, the participating physicians (i.e.general practitioners and internists) are asked to document relevant data related to the budesonide/formoterole therapy in patients with COPD.


Condition
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symbicort in Chronic Obstruktive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • efficacy and tolerability of budesonide /formoterole in subjects with COPD who are treated by general practitioners and internists. [ Time Frame: change of a quality of life score compared to baseline by using CRQ, stratified by present therapy and severity of COPD; incidence of the occurrence of unknown, unexpected and/or rarely occurring adverse events AE under outpatient medical care conditions ]

Secondary Outcome Measures:
  • to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population

Enrollment: 18014
Study Start Date: February 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with COPD treated with budesonide/formoterol

  Eligibility

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

general practitioners and internists

Criteria

Inclusion Criteria:

  • Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

  • limitiations; possible risks; warnings; contraindications mentioned in the SPC.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612976

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Kai Richter, MD Medical Department AstraZeneca Germany
  More Information

No publications provided

Responsible Party: Dr Kai Richter, AstraZeneca Germany
ClinicalTrials.gov Identifier: NCT00612976     History of Changes
Other Study ID Numbers: 1312006001, budesonide /formoterol, German PMS trial no.8
Study First Received: January 30, 2008
Last Updated: February 11, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
treatment of COPD
documentation of relevant data
related to the budesonide/formoterole therapy in patients with COPD.

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Symbicort
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014