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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 perennial allergic rhinitis (PAR).
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 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Perennial Allergic Rhinitis (PAR)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| 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. Subjects complete diaries twice daily (every 12 hours) reporting the severity of their PAR symptoms. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline over the entire treatment period in AM, pre-dose, instantaneous total nasal symptom scores. The subject completes an overall evaluation of response to therapy during the last clinic visit. |
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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 | Little Rock | Arkansas | 72205 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Nathan R, Berger W, Yang W, Cheema A, Silvey MJ, Wu W, Faris M, Philpot E. Once daily fluticasone furoate* nasal spray (FFNS), a novel enhanced affinity steroid, provides 24-hour relief for the nasal symptoms of perennial allergic rhinitis (PAR) J Allergy | ||
| 18517084 | Derived | Nathan RA, Berger W, Yang W, Cheema A, Silvey M, Wu W, Philpot E. Effect of once-daily fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2008 May;100(5):497-505. doi: 10.1016/S1081-1206(10)60477-2. |
| 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 |
|---|---|---|---|
| FFR30002 | Annotated Case Report Form | View IPD |
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| Los Angeles |
| California |
| 90025 |
| United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Miami | Florida | 33176 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Tampa | Florida | 33613 | United States |
| GSK Investigational Site | Vero Beach | Florida | 32960 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30045 | United States |
| GSK Investigational Site | Lilburn | Georgia | 30047 | United States |
| GSK Investigational Site | South Bend | Indiana | 46617 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Portland | Maine | 04102 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | Rockville | Maryland | 20850 | United States |
| GSK Investigational Site | North Andover | Massachusetts | 01845 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Springfield | Massachusetts | 01107 | United States |
| GSK Investigational Site | St Louis | Missouri | 63104 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68505 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68130 | United States |
| GSK Investigational Site | Ocean City | New Jersey | 07712 | United States |
| GSK Investigational Site | Summit | New Jersey | 07091 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Eugene | Oregon | 97401 | United States |
| GSK Investigational Site | Lake Oswego | Oregon | 97035 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02906 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203-1424 | United States |
| GSK Investigational Site | Austin | Texas | 78731 | United States |
| GSK Investigational Site | New Braunfels | Texas | 78130 | United States |
| GSK Investigational Site | Murray | Utah | 84107 | United States |
| GSK Investigational Site | South Burlington | Vermont | 05403 | United States |
| GSK Investigational Site | West Allis | Wisconsin | 53227 | United States |
| GSK Investigational Site | Kelowna | British Columbia | V1Y 9L8 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 4E1 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5A 1N1 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4M6 | Canada |
| GSK Investigational Site | Saskatoon | Saskatchewan | S7H 0V1 | Canada |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30002 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30002 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30002 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30002 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30002 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30002 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| 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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