Symbicort in Chronic Obstruktive Pulmonary Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00612976

Acronym

SYMBIOSE

Enrollment

18014

Registered

2008-02-12

Start date

2006-02-28

Completion date

Unknown

Last updated

2008-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

treatment of COPD, documentation of relevant data, related to the budesonide/formoterole therapy in patients with COPD.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with COPD treated with budesonide/formoterol

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results