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
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: 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 July 24, 2014