Symbicort in Chronic Obstruktive Pulmonary Disease (SYMBIOSE)

February 11, 2008 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

18014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

general practitioners and internists

Description

Inclusion Criteria:

  • Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with COPD treated with budesonide/formoterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Kai Richter, MD, Medical Department AstraZeneca Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

January 30, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2008

Last Update Submitted That Met QC Criteria

February 11, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1312006001
  • budesonide /formoterol
  • German PMS trial no.8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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