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GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving treatment sequence 1: Part 1 | Experimental | Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. |
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| Subjects receiving treatment sequence 2: Part 1 | Experimental | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. |
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| Subjects receiving treatment sequence 1: Part 2 | Experimental | Eligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms. |
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| Subjects receiving treatment sequence 2: Part 2 | Experimental | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo. |
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| Subjects receiving GSK615915A: Part 3 | Experimental | Eligible subjects will receive GSK615915A with a starting dose of 250 micrograms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK615915A | Drug | GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler. |
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| Measure | Description | Time Frame |
|---|---|---|
| Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG) | Up to 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of GSK615915A and any breakdown products in the blood and urine. | Up to 18 weeks |
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Inclusion Criteria:
The subject must be clinically stable The subject has a baseline FEV1 = 80% of predicted.
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 | Edinburgh | West Lothian | EH14 4AP | United Kingdom |
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| Label | URL |
|---|---|
| Results for study OLA103920 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D001986 | Bronchial Spasm |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| Subjects receiving placebo: Part 3 | Experimental | Eligible subjects will receive placebo. |
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| Placebo | Drug | Subjects will also receive placebo inhaler. |
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