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Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00435461
First received: February 14, 2007
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine


Condition Intervention Phase
Hayfever
Allergic Rhinitis
 Drug: Fluticasone furoate and fexofenadine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline over the two-week treatment period in the nighttime symptoms score (NSS)

Secondary Outcome Measures:
  • Mean change from baseline over the two-week treatment period in N-rTNSS, D-rTNSS, 24-hour rTNSS, N-rTOSS, D-rTOSS, 24-hour rTOSS, pre-dose iTNSS, pre-dose iTOSS, Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

Estimated Enrollment: 1000
Study Start Date: December 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fluticasone furoate and fexofenadine
    Other Name: Fluticasone furoate and fexofenadine
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Informed consent.
  • Outpatient.
  • Females of child-bearing potential must use appropriate contraception.
  • Diagnosis of seasonal allergic rhinitis to mountain cedar.
  • Adequate exposure to allergen.
  • Able to comply with study procedures.
  • Literate.

Exclusion criteria:

  • Significant concomitant medical condition.
  • Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
  • Positive pregnancy test.
  • Allergy to any component of the investigational product.
  • Tobacco use
  • Contact lens use
  • Has chickenpox or measles or recent exposure
  • Other clinical trial drug exposure in last 30 days
  • Affiliation with clinic site
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435461

Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78750
GSK Investigational Site
Austin, Texas, United States, 78731
GSK Investigational Site
Kerrville, Texas, United States, 78028
GSK Investigational Site
New Braunfels, Texas, United States, 78130
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78205
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00435461     History of Changes
Other Study ID Numbers: FFU109045
Study First Received: February 14, 2007
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
allergic rhinitis
mountain cedar
once daily
fluticasone furoate
fexofenadine

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone
Fexofenadine
Terfenadine
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
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013