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Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as 'hay fever', it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores (rTNSS). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline over the entire tx period in AM, pre-dose iTNS. Mean change from baseline over the entire treatment period in rTOSS. Overall evaluation of response to therapy. |
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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 | Tallinn | 13419 | Estonia | |||
| 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 |
|---|---|---|---|
| FFR103184 | Statistical Analysis Plan | 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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| Tartu |
| 51014 |
| Estonia |
| GSK Investigational Site | Liepāja | LV3401 | Latvia |
| GSK Investigational Site | Riga | LV 1001 | Latvia |
| GSK Investigational Site | Riga | LV 1002 | Latvia |
| GSK Investigational Site | Riga | LV 1003 | Latvia |
| GSK Investigational Site | Riga | LV 1004 | Latvia |
| GSK Investigational Site | Kaunas | LT-50009 | Lithuania |
| GSK Investigational Site | Kaunas | LT-50425 | Lithuania |
| GSK Investigational Site | Šiauliai | LT-78242 | Lithuania |
| GSK Investigational Site | Vilnius | LT-08661 | Lithuania |
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| GSK Investigational Site | Arnhem | 6824 BJ | Netherlands |
| GSK Investigational Site | Assen | 9401 RK | Netherlands |
| GSK Investigational Site | Leeuwarden | 8934 AD | Netherlands |
| GSK Investigational Site | Schiedam | 3116 BA | Netherlands |
| GSK Investigational Site | Tilburg | 5038 NM | Netherlands |
| GSK Investigational Site | Moscow | 115446 | Russia |
| GSK Investigational Site | Saint Petersburg | 190013 | Russia |
| GSK Investigational Site | Volgograd | 400130 | Russia |
| GSK Investigational Site | Ängelholm | SE-262 81 | Sweden |
| GSK Investigational Site | Lund | SE-221 85 | Sweden |
| GSK Investigational Site | Malmö | SE-211 36 | Sweden |
| GSK Investigational Site | Västerås | SE-721 89 | Sweden |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR103184 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR103184 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR103184 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR103184 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR103184 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR103184 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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