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

January 30, 2008
February 11, 2008
February 2006
September 2006   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00612976 on ClinicalTrials.gov Archive Site
to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population
Same as current
Not Provided
Not Provided
 
Symbicort in Chronic Obstruktive Pulmonary Disease
Symbicort in Chronic Obstruktive Pulmonary Disease

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

general practitioners and internists

Pulmonary Disease, Chronic Obstructive
Not Provided
1
Patients with COPD treated with budesonide/formoterol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18014
Not Provided
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

  • limitiations; possible risks; warnings; contraindications mentioned in the SPC.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00612976
1312006001, budesonide /formoterol, German PMS trial no.8
No
Dr Kai Richter, AstraZeneca Germany
AstraZeneca
Not Provided
Study Chair: Kai Richter, MD Medical Department AstraZeneca Germany
AstraZeneca
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP