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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00570492 |
Purpose
The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.
| Condition | Intervention | Phase |
|---|---|---|
|
Perennial Allergic Rhinitis |
Drug: fluticasone furoate nasal spray |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects With Perennial Allergic Rhinitis |
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 5 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Note: Subjects who meet the above criteria and who may also have seasonal allergic rhinitis (SAR) and/or non-allergic rhinitis (NAR) are eligible for randomization.
Exclusion criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Hide Study Locations| United States, Alabama | |
| GSK Investigational Site | Active, not recruiting |
| Oxford, Alabama, United States, 36203 | |
| United States, Arkansas | |
| GSK Investigational Site | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | Recruiting |
| Long Beach, California, United States, 90806 | |
| GSK Investigational Site | Recruiting |
| Long Beach, California, United States, 90808 | |
| GSK Investigational Site | Recruiting |
| Riverside, California, United States, 92506 | |
| GSK Investigational Site | Recruiting |
| Huntington Beach, California, United States, 92647 | |
| GSK Investigational Site | Recruiting |
| Vista, California, United States, 92083 | |
| GSK Investigational Site | Recruiting |
| Rolling Hills Estates, California, United States, 90274 | |
| United States, Florida | |
| GSK Investigational Site | Active, not recruiting |
| Coral Gables, Florida, United States, 33134 | |
| GSK Investigational Site | Active, not recruiting |
| Tampa, Florida, United States, 33613 | |
| GSK Investigational Site | Completed |
| Ocala, Florida, United States, 34471 | |
| United States, Georgia | |
| GSK Investigational Site | Completed |
| Stockbridge, Georgia, United States, 30281 | |
| GSK Investigational Site | Active, not recruiting |
| Gainesville, Georgia, United States, 30501 | |
| GSK Investigational Site | Active, not recruiting |
| Lawrenceville, Georgia, United States, 30045 | |
| United States, Indiana | |
| GSK Investigational Site | Recruiting |
| Indianapolis, Indiana, United States, 46208 | |
| GSK Investigational Site | Recruiting |
| Evansville, Indiana, United States, 47713 | |
| United States, Kansas | |
| GSK Investigational Site | Recruiting |
| Lenexa, Kansas, United States, 66215 | |
| United States, Louisiana | |
| GSK Investigational Site | Completed |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| GSK Investigational Site | Active, not recruiting |
| Baltimore, Maryland, United States, 21236 | |
| United States, Michigan | |
| GSK Investigational Site | Completed |
| Ypsilanti, Michigan, United States, 48197 | |
| United States, Missouri | |
| GSK Investigational Site | Recruiting |
| Rolla, Missouri, United States, 65401 | |
| GSK Investigational Site | Recruiting |
| Warrensburg, Missouri, United States, 64093 | |
| United States, Nebraska | |
| GSK Investigational Site | Recruiting |
| Papillion, Nebraska, United States, 68046 | |
| GSK Investigational Site | Recruiting |
| Omaha, Nebraska, United States, 68131 | |
| United States, Ohio | |
| GSK Investigational Site | Active, not recruiting |
| Canton, Ohio, United States, 44718 | |
| GSK Investigational Site | Recruiting |
| Sylvania, Ohio, United States, 43560 | |
| United States, Oklahoma | |
| GSK Investigational Site | Recruiting |
| Oklahoma City, Oklahoma, United States, 73112 | |
| GSK Investigational Site | Recruiting |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| GSK Investigational Site | Recruiting |
| Medford, Oregon, United States, 97504 | |
| GSK Investigational Site | Recruiting |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| GSK Investigational Site | Completed |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| GSK Investigational Site | Active, not recruiting |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| GSK Investigational Site | Completed |
| Altoona, Pennsylvania, United States, 16801 | |
| GSK Investigational Site | Active, not recruiting |
| Upland, Pennsylvania, United States, 19013 | |
| United States, South Carolina | |
| GSK Investigational Site | Recruiting |
| Charleston, South Carolina, United States, 29414 | |
| GSK Investigational Site | Active, not recruiting |
| Orangeburg, South Carolina, United States, 29118 | |
| GSK Investigational Site | Active, not recruiting |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| GSK Investigational Site | Recruiting |
| El Paso, Texas, United States, 79925 | |
| GSK Investigational Site | Recruiting |
| San Antonio, Texas, United States, 78205 | |
| GSK Investigational Site | Recruiting |
| Houston, Texas, United States, 77054 | |
| GSK Investigational Site | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | Active, not recruiting |
| Dallas, Texas, United States, 75230 | |
| GSK Investigational Site | Recruiting |
| Waco, Texas, United States, 76712 | |
| GSK Investigational Site | Completed |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | Recruiting |
| El Paso, Texas, United States, 79903 | |
| GSK Investigational Site | Recruiting |
| Kerrville, Texas, United States, 78028 | |
| United States, Vermont | |
| GSK Investigational Site | Recruiting |
| South Burlington, Vermont, United States, 05403 | |
| United States, Virginia | |
| GSK Investigational Site | Active, not recruiting |
| Richmond, Virginia, United States, 23229 | |
| GSK Investigational Site | Active, not recruiting |
| Richmond, Virginia, United States, 23219 | |
| Argentina | |
| GSK Investigational Site | Recruiting |
| Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE | |
| GSK Investigational Site | Recruiting |
| Buenos Aires, Argentina, C1425BEN | |
| GSK Investigational Site | Recruiting |
| Buenos Aires, Argentina, 1425 | |
| GSK Investigational Site | Recruiting |
| Mendoza, Argentina, M5500CCG | |
| GSK Investigational Site | Recruiting |
| Santa Fe, Argentina, 3000 | |
| Argentina, Buenos Aires | |
| GSK Investigational Site | Recruiting |
| 9 de Julio, Buenos Aires, Argentina, B6500BWQ | |
| Argentina, Santa Fe | |
| GSK Investigational Site | Recruiting |
| Rosario, Santa Fe, Argentina, S2000DBS | |
| GSK Investigational Site | Recruiting |
| Rosario, Santa Fe, Argentina, 2000 | |
| Canada, Manitoba | |
| GSK Investigational Site | Completed |
| Winnipeg, Manitoba, Canada, R2M 5L9 | |
| Canada, Ontario | |
| GSK Investigational Site | Completed |
| Mississauga, Ontario, Canada, L5A 3V4 | |
| GSK Investigational Site | Recruiting |
| Brampton, Ontario, Canada, L6T 3T1 | |
| GSK Investigational Site | Completed |
| Toronto, Ontario, Canada, M4V 1R2 | |
| Canada, Prince Edward Island | |
| GSK Investigational Site | Completed |
| Charlottetown, Prince Edward Island, Canada, C1A 8T5 | |
| Canada, Quebec | |
| GSK Investigational Site | Completed |
| Trois Rivières, Quebec, Canada, G8T 7A1 | |
| GSK Investigational Site | Recruiting |
| Quebec City, Quebec, Canada, G1V 4M6 | |
| Chile, Región Metro De Santiago | |
| GSK Investigational Site | Recruiting |
| Santiago, Región Metro De Santiago, Chile | |
| Chile, Valparaíso | |
| GSK Investigational Site | Recruiting |
| Viña del Mar, Valparaíso, Chile | |
| France | |
| GSK Investigational Site | Recruiting |
| Montpellier, France, 34295 | |
| GSK Investigational Site | Recruiting |
| Laon, France, 02000 | |
| GSK Investigational Site | Recruiting |
| Le Havre, France, 76083 | |
| Italy, Lombardia | |
| GSK Investigational Site | Not yet recruiting |
| Milano, Lombardia, Italy, 20129 | |
| GSK Investigational Site | Recruiting |
| Milano, Lombardia, Italy, 20122 | |
| Italy, Umbria | |
| GSK Investigational Site | Recruiting |
| Perugia, Umbria, Italy, 06156 | |
| Peru | |
| GSK Investigational Site | Active, not recruiting |
| Lima, Peru, Lima 27 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | FFR101782 |
| Study First Received: | December 6, 2007 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00570492 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
fluticasone furoate nasal spray allergic rhinitis growth |
|
Anti-Inflammatory Agents Respiratory System Agents Otorhinolaryngologic Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Rhinitis Anti-Allergic Agents Pharmacologic Actions Nose Diseases Hypersensitivity |
Rhinitis, Allergic, Perennial Respiratory Tract Diseases Respiratory Tract Infections Autonomic Agents Therapeutic Uses Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |