Fluticasone Nasal Spray Patient Preference Study - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00398476

Purpose

The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: fluticasone propionate Drug: fluticasone furoate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Official Title:	A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

overall subject preference for nasal spray

Secondary Outcome Measures:

subject preference for individual attributes

Estimated Enrollment:	125
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

allergic rhinitis
literate

Exclusion Criteria:

clinical significant uncontrolled disease
Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
Use of intranasal medications <1 week
Use of meds that significantly inhibit CYP4503A4
Use of perfume or oral rinse on study day
Allergy/intolerance to INS, antihistamines, or excipients
Positive pregnancy test or female who is breastfeeding
Affiliation with investigational site

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398476

Locations

United States, California
GSK Clinical Trials Call Center
Fountain Valley, California, United States, 92708
GSK Clinical Trials Call Center
San Diego, California, United States, 92123
GSK Clinical Trials Call Center
Long Beach, California, United States, 90807
United States, Colorado
GSK Clinical Trials Call Center
Lakewood, Colorado, United States, 80401
GSK Clinical Trials Call Center
Denver, Colorado, United States, 80230
United States, Georgia
GSK Clinical Trials Call Center
Savannah, Georgia, United States, 31406
GSK Clinical Trials Call Center
Conyers, Georgia, United States, 30013
United States, Michigan
GSK Clinical Trials Call Center
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
GSK Clinical Trials Call Center
Minneapolis, Minnesota, United States, 55402
United States, Missouri
GSK Clinical Trials Call Center
St. Louis, Missouri, United States, 63141
GSK Clinical Trials Call Center
Rolla, Missouri, United States, 65401
United States, New Jersey
GSK Clinical Trials Call Center
Skillman, New Jersey, United States, 08558
GSK Clinical Trials Call Center
Brick, New Jersey, United States, 08724
United States, South Carolina
GSK Clinical Trials Call Center
Charleston, South Carolina, United States, 29414
United States, Texas
GSK Clinical Trials Call Center
El Paso, Texas, United States, 79925

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	FFU108556
Study First Received:	November 9, 2006
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00398476 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

preference
attributes
scent
odor

taste
after taste
questionnaire

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Otorhinolaryngologic Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions

Respiratory Tract Diseases
Respiratory Tract Infections
Autonomic Agents
Therapeutic Uses
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 30, 2009