Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
pharmacovigilance, COPD
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.
Interventions
Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI)
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed