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The purpose of this study is to compare the effects of SB-480848 with placebo in subjects with asthma.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB 480848, tablets | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | 6 hours post-dose, Days 7, 14 and 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Methacholine challenge Amounts of certain chemicals/proteins in blood Amount of drug in the blood | before dosing and after 21 days of dosing | |
| Measurements of FEV1 following single doses of SB-480848 and placebo. |
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Inclusion Criteria:
Inclusion Criteria following run in period (Prior to randomisation) Subjects will be screened based on the inclusion and exclusion criteria noted above.
During the run-in period [Day -14 to Day 1], subjects will be asked to maintain a diary card and document the number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings as well as morning and evening PEF measurements.
On the morning of Day 0, subjects will be eligible for randomisation into the study if all of the following criteria are met:
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 | Cypress | California | 90630 | United States | ||
| GSK Investigational Site |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LPL107629 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C529040 | darapladib |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Measurements of PC20 on Day 21 +24hrs after dosing with SB-480848 and placebo. | Day 21 +24hrs after dosing |
| Blood drug levels of SB-553253 [metabolite of SB-480848] may be assessed, as appropriate. |
| Urinary leukotriene concentrations after 21 days of dosing with SB-480848 and Placebo. | after 21 days |
| Blood levels of LpPLA2 and CD62 concentrations over 21-day dosing period with SB-480848 and placebo | over 21-day dosing period |
| Measurements of FEF25-75 and peak expiratory flow following single and repeat oral doses of SB-480848. |
| Assessment of vitals, ECGs, safety labs and number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings, number of subjects withdrawn due to worsening of asthma on SB- 480848 and placebo. |
| Normal |
| Illinois |
| 61761 |
| United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Neu-Ulm | Bavaria | 89231 | Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 14050 | Germany |
For additional information about this study please refer to the GSK Clinical Study Register |
| LPL107629 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL107629 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL107629 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL107629 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL107629 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LPL107629 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |