Symbicort in Chronic Obstruktive Pulmonary Disease - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00612976

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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Budesonide Symbicort

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Symbicort in Chronic Obstruktive Pulmonary Disease

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

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Responsible Party:	AstraZeneca Germany ( Dr Kai Richter )
Study ID Numbers:	1312006001, budesonide /formoterol, German PMS trial no.8
Study First Received:	January 30, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00612976
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.

Study placed in the following topic categories:

Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Budesonide
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 13, 2009