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The purpose of this study is to determine if the investigational drug is effective and safe in children with perennial allergic rhinitis.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to <12 Years with Perennial Allergic Rhinitis (PAR)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in daily, reflective total nasal symptom scores after first 4-week treatment period in subjects ages 6 to <12 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in AM, pre-dose, instantaneous total nasal symptom scores after first 4-week treatment period, overall evaluation of response to therapy for the first 4-week treatment period for subjects ages 6 to <12 years. |
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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 | Costa Mesa | California | 92626 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Máspero J, Rosenblut A, Finn A, J Lim J, Wu W, Philpot E. Safety of fluticasone furoate* nasal spray in children with perennial allergic rhinitis (*USAN approved name). Allergy 2007;62(Suppl. 83): 381 (abstract). | ||
| Result | Máspero JF, Rosenblut A, Finn A, Lim J, Wu W, Faris M, Philpot E. Once-daily fluticasone furoate nasal spray (FF) is safe and effective in the long-term treatment of perennial allergic rhinitis (PAR) in children ages 2 to 11 years. J Allergy Clin Immunol. | ||
| 18164990 | Result | Maspero JF, Rosenblut A, Finn A Jr, Lim J, Wu W, Philpot E. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck Surg. 2008 Jan;138(1):30-7. doi: 10.1016/j.otohns.2007.10.023. |
| 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 |
|---|---|---|---|
| FFR30008 | Individual Participant Data Set | 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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| Cudahy |
| California |
| 90201 |
| United States |
| GSK Investigational Site | Long Beach | California | 90806 | United States |
| GSK Investigational Site | Long Beach | California | 90808 | United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | Sacramento | California | 95819 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Denver | Colorado | 80206 | United States |
| GSK Investigational Site | Denver | Colorado | 80230 | United States |
| GSK Investigational Site | Englewood | Colorado | 80112 | United States |
| GSK Investigational Site | Coral Gables | Florida | 33134 | United States |
| GSK Investigational Site | Gainesville | Georgia | 30501 | United States |
| GSK Investigational Site | Lawrenceville | Georgia | 30045 | United States |
| GSK Investigational Site | Stockbridge | Georgia | 30281 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71105 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21236 | United States |
| GSK Investigational Site | Ypsilanti | Michigan | 48197 | United States |
| GSK Investigational Site | Jackson | Mississippi | 39202 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64108 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68130 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68131 | United States |
| GSK Investigational Site | Brick | New Jersey | 8724 | United States |
| GSK Investigational Site | Ithaca | New York | 14850 | United States |
| GSK Investigational Site | Liverpool | New York | 13090 | United States |
| GSK Investigational Site | Rochester | New York | 14618 | United States |
| GSK Investigational Site | Rochester | New York | 14627 | United States |
| GSK Investigational Site | Utica | New York | 13502 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73120 | United States |
| GSK Investigational Site | Lake Oswego | Oregon | 97035 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Bellevue | Pennsylvania | 15202 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| GSK Investigational Site | Upland | Pennsylvania | 19013 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37922 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203-1424 | United States |
| GSK Investigational Site | El Paso | Texas | 79902 | United States |
| GSK Investigational Site | Buenos Aires | Buenos Aires | 1425 | Argentina |
| GSK Investigational Site | Nueve de Julio | Buenos Aires | B6500BWQ | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | 2000 | Argentina |
| GSK Investigational Site | Santa Fe | Santa Fe Province | 3000 | Argentina |
| GSK Investigational Site | Santiago | Región Metro de Santiago | Chile |
| GSK Investigational Site | Viña del Mar | Valparaiso | Chile |
| GSK Investigational Site | Joensuu | 80100 | Finland |
| GSK Investigational Site | Nokia | 37100 | Finland |
| GSK Investigational Site | Tampere | 33200 | Finland |
| GSK Investigational Site | Turku | 20610 | Finland |
| GSK Investigational Site | Naples | Campania | 80138 | Italy |
| GSK Investigational Site | Bari | 70124 | Italy |
| GSK Investigational Site | Milan | 52-20129 | Italy |
| GSK Investigational Site | Monticelli Ascoli Piceno | 63100 | Italy |
| GSK Investigational Site | Perugia | 06126 | Italy |
| GSK Investigational Site | Salerno | 84100 | Italy |
| GSK Investigational Site | México | 04530 | Mexico |
| GSK Investigational Site | México | 6720 | Mexico |
| GSK Investigational Site | Monterrey, N.L | 64460 | Mexico |
| GSK Investigational Site | Banská Bystrica | 974 01 | Slovakia |
| GSK Investigational Site | Bratislava | 821 06 | Slovakia |
| GSK Investigational Site | Levoča | 054 01 | Slovakia |
| GSK Investigational Site | Nitra | 949 01 | Slovakia |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30008 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30008 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30008 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30008 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30008 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR30008 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| 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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