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This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB681323 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP) |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aalborg | DK-9100 | Denmark | |||
| GSK Investigational Site |
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| København NV |
| 2400 |
| Denmark |
| GSK Investigational Site | Helsinki | 00029 | Finland |
| GSK Investigational Site | Gauting | Bavaria | 82131 | Germany |
| GSK Investigational Site | Hamburg | Free and Hanseatic City of Hamburg | 20535 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Dordrecht | 3317 NM | Netherlands |
| GSK Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| GSK Investigational Site | Maastricht | 6229 HX | Netherlands |
| GSK Investigational Site | Rotterdam | 3000 DR | Netherlands |
| GSK Investigational Site | Liverpool | Lancashire | L9 7AL | United Kingdom |
| GSK Investigational Site | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | Northumberland | NE7 7DN | United Kingdom |
| GSK Investigational Site | Belfast | BT9 6AB | United Kingdom |
| GSK Investigational Site | Hull | HU16 5JQ | United Kingdom |
| GSK Investigational Site | London | E2 9JX | United Kingdom |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C574213 | dilmapimod |
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