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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00519636 |
Purpose
The purpose of this replicate study to FFU105924 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 FFNS Drug: placebo FPNS |
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, MCStudy to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcgFluticasone Propionate Nasal Spray in Adult Subjects With Seasonal Allergic Rhiniti |
| Enrollment: | 360 |
| 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 FFNS
placebo nasal spray matching fluticasone furoate nasal spray
Drug: placebo FPNS
placebo nasal spray matching fluticasone propionate nasal spray
|
| Placebo Comparator: placebo FPNS, placebo FFNS |
Drug: placebo FFNS
placebo nasal spray matching fluticasone furoate nasal spray
Drug: placebo FPNS
placebo nasal spray matching fluticasone propionate 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 (FFU105927)
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
Show 28 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00519636 History of Changes |
| Other Study ID Numbers: | FFU105927 |
| Study First Received: | August 21, 2007 |
| Results First Received: | November 7, 2008 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
experience GW685698X fluticasone furoate |
preference seasonal allergic rhinitis fluticasone propionate |
|
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 |