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The purpose of the study is to 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 |
|---|---|---|---|---|
| fluticasone furoate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline over the entire treatment period in daily, reflective, total nasal symptom scores. | ||
| Mean change from baseline over the entire treatment period in the daily, reflective, total ocular symptom score. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous, total nasal symptom score. |
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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 | Austin | Texas | 78731 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Hampel FC Jr, Jacobs R, Martin B. Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) provides 24-hour symptom relief in subjects with seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J | ||
| 19419338 | Background | Jacobs R, Martin B, Hampel F, Toler W, Ellsworth A, Philpot E. Effectiveness of fluticasone furoate 110 microg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen. Curr Med Res Opin. 2009 Jun;25(6):1393-401. doi: 10.1185/03007990902890512. | |
| Background | Ratner P, Andrews C, van Bavel J, Toler T, Ellsworth A, Philpot E. Once-daily fluticasone furoate* nasal spray (FF) effectively treats ocular symptoms of seasonal allergic rhinitis (SAR) caused by mountain cedar pollen. *USAN approved name. J Allergy Cli | ||
| 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 |
|---|---|---|---|
| FFR30003 | Annotated Case Report 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 |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
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| Austin |
| Texas |
| 78759 |
| United States |
| GSK Investigational Site | New Braunfels | Texas | 78130 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| Background |
| van Bavel J, Toler T, Ellsworth A, Stanford R, Philpot E. Once-daily fluticasone furoate* nasal spray (FFNS) improves quality of life (QoL) in subjects with seasonal allergic rhinitis (SAR) during the mountain cedar pollen season. *USAN approved name. J |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30003 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30003 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30003 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30003 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30003 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30003 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |