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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with COPD treated with budesonide/formoterol

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: SYMBIOSE

Important dates

Study start: 2006
Primary completion: 2006
First posted: Feb 12, 2008
Registry last updated: Feb 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed