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| ID | Type | Description | Link |
|---|---|---|---|
| Seretide-pv/GR | Other Identifier | GlaxoSmithKline |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salmeterol/Fluticasone propionate (50/500 μg) | Open label, 6 visits, single arm study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/Fluticasone propionate | Drug | Open label, of Salmeterol/Fluticasone propionate (50/500 μg) twice daily via dry powder inhaler (DPI) |
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| Measure | Description | Time Frame |
|---|---|---|
| The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria) | Evaluate adverse events, vital sign reporting, and concomitant medications | 104 weeks |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Planned: 1000 / Recruited: 771 / Analyzed: 771 A target enrolment of approximately 1000 subjects is planned, at outpatient sites. Any subject with COPD who has an indication to receive Salmeterol + Fluticasone 50/500mcg twice daily at the discretion of the investigator and has met all the inclusion criteria, may take part in the study.
Inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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Participants will undergo physical examination and blood pressure measurement. A complete medical history will be taken, as well as blood and urine samples.
| every 26 weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |