Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Salmeterol/Fluticasone propionate

Study type: Observational

Funder types: Industry

Identifiers

NCT00662805

104246

Seretide-pv/GR (Other Identifier)

Details and patient eligibility

About

Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase.

Enrollment: 762 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.

Exclusion criteria

• Hypersensitivity to Salmeterol + Fluticasone or any of its excipients
• Pregnancy, lactation or scheduled pregnancy during the observational period of the study
• Serious illness/disease, not adequately controlled, or with a potential to interfere with the patients' participation in the present study, according to the investigator/physician's judgment.

Trial design

762 participants in 1 patient group

Salmeterol/Fluticasone propionate (50/500 μg)

Description:

Open label, 6 visits, single arm study

Treatment:

Drug: Salmeterol/Fluticasone propionate