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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00539006 |
Purpose
The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.
| Condition | Intervention | Phase |
|---|---|---|
|
Rhinitis, Allergic, Perennial Seasonal Allergic Rhinitis |
Drug: FPNS Drug: FFNS Drug: placebo FPNS Drug: placebo FFNS |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | R, DB, PC, AC, One-Week, Cross-Over, MC Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg FFNS and 200mcg FPNS in Adult Subjects With SAR |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: FFNS, FPNS |
Drug: FPNS
fluticasone propionate nasal spray
Other Names:
Drug: FFNS
fluticasone furoate nasal spray
|
| Active Comparator: FPNS, FFNS |
Drug: FPNS
fluticasone propionate nasal spray
Other Names:
Drug: FFNS
fluticasone furoate nasal spray
|
| Placebo Comparator: placebo FFNS, placebo FPNS |
Drug: placebo FPNS
placebo nasal spray matching fluticasone propionate nasal spray
Drug: placebo FFNS
placebo nasal spray matching fluticasone furoate nasal spray
|
| Placebo Comparator: placebo FPNS, placebo FFNS |
Drug: placebo FPNS
placebo nasal spray matching fluticasone propionate nasal spray
Drug: placebo FFNS
placebo nasal spray matching fluticasone furoate nasal spray
|
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:
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 | |
| Huntington Beach, California, United States, 92647 | |
| GSK Investigational Site | |
| Long Beach, California, United States, 90808 | |
| 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 | |
| Brick, New Jersey, United States, 8724 | |
| GSK Investigational Site | |
| Skillman, New Jersey, United States, 08558 | |
| 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 | |
| Charleston, South Carolina, United States, 29414 | |
| GSK Investigational Site | |
| Charleston, South Carolina, United States, 29407 | |
| GSK Investigational Site | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| GSK Investigational Site | |
| Corsicana, Texas, United States, 75110 | |
| GSK Investigational Site | |
| El Paso, Texas, United States, 79902 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77070 | |
| GSK Investigational Site | |
| Kerrville, Texas, United States, 78028 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| United States, Vermont | |
| GSK Investigational Site | |
| South Burlington, Vermont, United States, 05403 | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00539006 History of Changes |
| Other Study ID Numbers: | FFU105924 |
| Study First Received: | October 2, 2007 |
| Results First Received: | November 14, 2008 |
| Last Updated: | December 15, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
fluticasone propionate seasonal allergic rhinitis fluticasone furoate |
experience GW685698X preference |
|
Rhinitis, Allergic, Seasonal Rhinitis Rhinitis, Allergic, Perennial Nose Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Otorhinolaryngologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiratory Tract Infections Fluticasone |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |