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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 30, 2008

Last Updated Date

February 11, 2008

Start Date ^ICMJE

February 2006

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00612976 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Symbicort in Chronic Obstruktive Pulmonary Disease

Official Title ^ICMJE

Symbicort in Chronic Obstruktive Pulmonary Disease

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

general practitioners and internists

Condition ^ICMJE

Pulmonary Disease, Chronic Obstructive

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients with COPD treated with budesonide/formoterol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

18014

Completion Date

Not Provided

Primary Completion Date

September 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with COPD treated with budesonide/formoterol

Exclusion Criteria:

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00612976

Other Study ID Numbers ^ICMJE

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

Has Data Monitoring Committee

Responsible Party

Dr Kai Richter, AstraZeneca Germany

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Kai Richter, MD

Medical Department AstraZeneca Germany

Information Provided By

AstraZeneca

Verification Date

January 2008

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

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