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The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving GSK256066 | Experimental | Eligible subjects will be randomized to receive GSK256066 with inhaled doses of 25 micrograms or 87.5 micrograms once daily for 7 days, administered via an ACCUHALER. |
|
| Subjects receiving placebo | Placebo Comparator | Eligible subjects will be randomized to receive placebo for 7 days, administered via an ACCUHALER. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK256066 | Drug | GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8 | Day 1,Day 7&DAY 8 |
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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 | Hanover | Lower Saxony | 30625 | Germany |
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| Label | URL |
|---|---|
| Results for study IPC103711 can be found on the GSK Clinical Study Register. | View source |
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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 |
|---|---|
| C549469 | 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide |
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| Placebo | Drug | Subjects will receive placebo inhaler. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |