Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Salmeterol/Fluticasone propionate
- Registration Number
- NCT00662805
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 762
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Salmeterol/Fluticasone propionate (50/500 μg) Salmeterol/Fluticasone propionate Open label, 6 visits, single arm study
- Primary Outcome Measures
Name Time Method The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria) 104 weeks Evaluate adverse events, vital sign reporting, and concomitant medications
- Secondary Outcome Measures
Name Time Method Trough FEV1, FVC and FEV1/ FVC ratio every 26 weeks Health status as determined using the St George's Respiratory Questionnaire (SGRQ) 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 every 26 weeks