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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. The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with seasonal allergic rhinitis (SAR) caused by ragweed pollen.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 2 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Seasonal Allergic Rhinitis (SAR)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X Aqueous Nasal Spray | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline over the entire treatment period in daily, reflective total nasal symptom scores. |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. 2) Mean change from baseline in daily reflective total ocular symptom scores. 3) 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 | Chicago | Illinois | 60637 | 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 |
|---|---|---|---|
| FFR104861 | Clinical Study Report | 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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| Indianapolis |
| Indiana |
| 46208 |
| United States |
| GSK Investigational Site | Lafayette | Indiana | 47904 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40215 | United States |
| GSK Investigational Site | Novi | Michigan | 48375 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Rolla | Missouri | 65401 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68505 | United States |
| GSK Investigational Site | Papillion | Nebraska | 68046 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Sylvania | Ohio | 43560 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Dallas | Texas | 75231-4307 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Greenfield | Wisconsin | 53228 | United States |
| GSK Investigational Site | West Allis | Wisconsin | 53227 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR104861 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR104861 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR104861 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR104861 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR104861 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR104861 | 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 |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| 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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