Symbicort in Chronic Obstruktive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

— SYMBIOSE  

Official title:

Symbicort in Chronic Obstruktive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612976
• Other study ID #: 1312006001
• Secondary ID: budesonide /form
• Status: Completed
• Phase: N/A
• First received: January 30, 2008
• Last updated: February 11, 2008
• Start date: February 2006

Study information

• Verified date: January 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18014
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

• limitiations; possible risks; warnings; contraindications mentioned in the SPC.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy and tolerability of budesonide /formoterole in subjects with COPD who are treated by general practitioners and internists.		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	to get further insight into the details of the use , dosage scheme and duration of treatment with budesonide /formoterol in this population