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This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3. |
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| Sequence 2 | Experimental | Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3. |
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| Sequence 3 | Experimental | Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3. |
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| Sequence 4 | Experimental | Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3. |
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| Sequence 5 | Experimental | Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW274150 | Drug | GW274150 will be available as 30 mg white oval tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect on the late asthmatic reaction following an inhaled allergen challenge | Up to Day 115 |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of safety. Measures of lung function | Up to Day 115 |
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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 | Manchester | Lancashire | M23 9LT | United Kingdom | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17717202 | Derived | Singh D, Richards D, Knowles RG, Schwartz S, Woodcock A, Langley S, O'Connor BJ. Selective inducible nitric oxide synthase inhibition has no effect on allergen challenge in asthma. Am J Respir Crit Care Med. 2007 Nov 15;176(10):988-93. doi: 10.1164/rccm.200704-588OC. Epub 2007 Aug 23. |
| Label | URL |
|---|---|
| Results for study 102141 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C409004 | GW 274150 |
| C093875 | montelukast |
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| Sequence 6 | Experimental | Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3. |
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| Singulair | Drug | Singulair will be available as over encapsulated 10 mg orange tablets. |
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| Placebo | Drug | Matching placebo for Singulair and GW274150 will be available. |
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| London |
| SE1 9RT |
| United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |