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

GlaxoSmithKline762 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

762

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol/Fluticasone propionateDRUG

Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)

Evaluate adverse events, vital sign reporting, and concomitant medications

Time frame: 104 weeks

Secondary Outcomes

Trough FEV1, FVC and FEV1/ FVC ratio

Time frame: every 26 weeks

Health status as determined using the St George's Respiratory Questionnaire (SGRQ)

Time frame: every 26 weeks

Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria

Time frame: every 26 weeks

Data from ClinicalTrials.gov

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