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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00539006 |
Purpose
The purpose of this replicate study to FFU105927 (NCT00519636) is to provide data on subject preference of FFNS as compared with FPNS.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: fluticasone propionate Drug: fluticasone furoate Drug: placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | See Detailed Description |
| Enrollment: | 377 |
| Study Start Date: | August 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105924)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A positive skin test is defined as a wheal 3 mm larger than the diluent control for prick testing. In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed as a diagnosis of SAR.
Subjects who meet the above criteria and who may also have perennial allergic rhinitis or vasomotor rhinitis are eligible for randomization.
Subject does not plan to travel outside this area for more than 48 hours of the study period.
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| GSK Investigational Site | |
| Scottsdale, Arizona, United States, 85251 | |
| United States, California | |
| GSK Investigational Site | |
| Fresno, California, United States, 93720 | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90808 | |
| GSK Investigational Site | |
| Huntington Beach, California, United States, 92647 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21236 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| North Andover, Massachusetts, United States, 01845 | |
| United States, Mississippi | |
| GSK Investigational Site | |
| Jackson, Mississippi, United States, 39202 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Skillman, New Jersey, United States, 08558 | |
| GSK Investigational Site | |
| Brick, New Jersey, United States, 8724 | |
| United States, New York | |
| GSK Investigational Site | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| GSK Investigational Site | |
| Charleston, South Carolina, United States, 29414 | |
| GSK Investigational Site | |
| Charleston, South Carolina, United States, 29407 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77070 | |
| GSK Investigational Site | |
| Corsicana, Texas, United States, 75110 | |
| GSK Investigational Site | |
| El Paso, Texas, United States, 79902 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Kerrville, Texas, United States, 78028 | |
| United States, Vermont | |
| GSK Investigational Site | |
| South Burlington, Vermont, United States, 05403 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | FFU105924 |
| Study First Received: | October 2, 2007 |
| Results First Received: | November 14, 2008 |
| Last Updated: | September 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00539006 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
seasonal allergic rhinitis fluticasone furoate GS685698X fluticasone propionate |
EARNS-Q preference experience |
|
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 |
Respiratory Tract Diseases Respiratory Tract Infections Autonomic Agents Therapeutic Uses Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |