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This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | 3 incremental capsaicin doses |
|
| Arm 2 | Active Comparator | 3 incremental capsaicin doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | SB-705498 placebo |
| |
| SB-705498 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of total symptom score (TSS) after unilateral, incremental dose, intranasal challenge with capsaicin | 0-4hours following dosing | |
| Assessment of total Ipsilateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin | 0-4hours following dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in peak nasal inspiratory flow (PNIF) after unilateral, incremental dose, intranasal challenge with capsaicin | 0-4hours following dosing | |
| Assessment of Total Contralateral secretion's weight after unilateral, incremental dose, intranasal challenge with capsaicin |
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Inclusion Criteria:
Exclusion Criteria:
Past medical history of allergic rhinitis or rhinosinusitis.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
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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 |
|---|---|---|---|
| 111925 | 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 11, 2017 | |
| Reset | Mar 23, 2018 | |
| Release | Mar 29, 2018 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2017 | Mar 23, 2018 | |||
| Mar 29, 2018 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C512301 | SB 705498 |
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| Drug |
12mg intranasal SB-705498 |
|
| 0-4hours following dosing |
| Number of participants with Individual Symptoms as assessed by TSS components after unilateral, incremental dose, intranasal challenge with capsaicin | 0-4hours |
| Soluble biochemical mediators, including but not limited to neuropeptides, in nasal secretions induced after unilateral, incremental dose, intranasal challenge with capsaicin | 0-4hours following dosing |
| Intranasal, single dose SB-705498 plasma PK parameters-Cmax | 0-4hours |
| Intranasal, single dose SB-705498 plasma PK parameters- Tmax | 0-4hours post dosing |
| Intranasal, single dose SB-705498 plasma PK parameters- AUC(0-t) | 0-4hours post dosing |
| Number of participants with adverse events | Day 1 |
| Number of participants with vital signs data outside range of potential clinical importance- Systolic blood pressure (SBP) and diastolic blood pressure (DBP) | Day 1 |
| Heart rate | Day 1 |
| Number of participants with nasal examination data | Day 1 |
| Number of participants with abnormal ECG findings | Day 1 |
| Body temperature | Day 1 |
| Number of participants with abnormal hematology values | Day 1 |
| Number of participants with abnormal clinical chemistry values- Carbon dioxide content/Bicarbonate, Cholesterol, Potassium, Triglycerides | Day 1 |
| Number of participants with abnormal clinical chemistry values- Creatinine | Day 1 |
| Number of participants with abnormal clinical chemistry values- Gamma Glutamyl Transferase, Lactate Dehydrogenase | Day 1 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111925 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111925 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111925 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111925 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111925 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111925 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D010038 |
| Otorhinolaryngologic Diseases |