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Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS

A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects With Seasonal Allergic Rhinitis

NCT00519636•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.

Detailed Description

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Informed consent
•Subject has provided an appropriately signed and dated informed consent.
•Otherwise healthy outpatient with fall allergy
•Subject is treatable on an outpatient basis.
•Age
•18 years or age or older at time of Visit 2
•Male or eligible female
•Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be required of all females at all visits to determine if the subject is pregnant.
•To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
•Abstinence
+55 more criteria

Exclusion Criteria

•Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST).
•Significant concomitant medical conditions, defined as but not limited to:
•A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
•A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug
•Nasal (eg, nasal septum) injury or surgery in the last 3 months
•Asthma, with the exception of mild intermittent asthma \[National Asthma Education and Prevention Program (NARPP) Guidelines, 2002\].
•Rhinitis medicamentosa
•Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period
•Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
•Current or history of glaucoma and/or cataracts or ocular herpes simplex Physical impairment that would affect subject's ability to participate safely and fully in the study
+4 more criteria

Locations (28)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

San Jose, California, United States

GSK Investigational Site

Vista, California, United States

GSK Investigational Site

Tallahassee, Florida, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

November 1, 2007

Completion Date

November 1, 2007

Last Updated

December 9, 2016

Enrollment

360

ACTUAL participants

Conditions

Rhinitis, Allergic, Perennial

Interventions

FPNS

DRUG

FFNS

DRUG

placebo FFNS

DRUG

placebo FPNS

DRUG

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

NCT00779545

Rhinitis, Allergic, Perennial

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COMPLETEDPHASE3

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

NCT00406783

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS

Inclusion Criteria

Exclusion Criteria

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

Single Dosing Clinical Trial of HL151

Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)