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Fluticasone Nasal Spray Patient Preference Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00398476
First received: November 9, 2006
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  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
Rhinitis, Allergic, Perennial
Allergic Rhinitis
 Drug: fluticasone propionate
Drug: fluticasone furoate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluticasone propionate Drug: fluticasone furoate
    Other Names:
    • fluticasone furoate
    • fluticasone propionate
  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 Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
San Diego, California, United States, 92123
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80230
GSK Investigational Site
Lakewood, Colorado, United States, 80401
United States, Georgia
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Savannah, Georgia, United States, 31406
United States, Michigan
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
GSK Investigational Site
Rolla, Missouri, United States, 65401
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Brick, New Jersey, United States, 8724
GSK Investigational Site
Skillman, New Jersey, United States, 08558
United States, Texas
GSK Investigational Site
El Paso, Texas, United States, 79925
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00398476     History of Changes
Other Study ID Numbers: FFU108556
Study First Received: November 9, 2006
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
taste
questionnaire
preference
attributes
 odor
after taste
scent

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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

ClinicalTrials.gov processed this record on May 23, 2013