Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00502775
First received: July 17, 2007
Last updated: August 20, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Allergic Rhinitis
Hayfever
Drug: fluticasone furoate, 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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in the Nighttime Symptom Score (NSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: Baseline and Weeks 1-2 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) [ Time Frame: Baseline, Day 15 or if Early Withdrawal Day ] [ Designated as safety issue: No ]

Enrollment: 680
Study Start Date: August 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: fluticasone furoate, fexofenadine
    Other Name: fluticasone furoate, fexofenadine
  Eligibility

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

Inclusion criteria:

  • Informed consent
  • Otherwise healthy outpatient with mountain cedar allergy
  • Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
  • Age 12 years or older at Visit 2
  • Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
  • Adequate exposure to mountain cedar pollen
  • Ability to comply with study procedures
  • Literate

Exclusion criteria:

  • Significant concomitant medical conditions
  • Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
  • Use of other allergy medications within specific timeframes relative to Visit 1
  • Use of other medications that may affect allergic rhinitis or its symptoms
  • Use of immunosuppressive medications eight weeks prior to screening and during the study
  • Immunotherapy patients who are not stable on current dose
  • Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
  • Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
  • Use of contact lenses
  • Recent clinical trial/experimental medication experience within 30 days of Visit 1
  • Subject previously failed the 21-day screen period or failed to complete the treatment period
  • Positive or inconclusive pregnancy test or female who is breastfeeding
  • Employee or relative affiliation with investigational site
  • Current tobacco use
  • Active chickenpox or measles or exposure in the last 3 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502775

  Hide Study Locations
Locations
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
United States, Georgia
GSK Investigational Site
Albany, Georgia, United States, 31707
GSK Investigational Site
Columbus, Georgia, United States, 31904
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60637
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47713
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
GSK Investigational Site
Lafayette, Indiana, United States, 47904
GSK Investigational Site
South Bend, Indiana, United States, 46617
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
GSK Investigational Site
Louisville, Kentucky, United States, 40215
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Michigan
GSK Investigational Site
Novi, Michigan, United States, 48375
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Columbia, Missouri, United States, 65203
GSK Investigational Site
Rolla, Missouri, United States, 65401
GSK Investigational Site
St. Louis, Missouri, United States, 63110
GSK Investigational Site
St. Louis, Missouri, United States, 63141
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
GSK Investigational Site
Omaha, Nebraska, United States, 68130
GSK Investigational Site
Omaha, Nebraska, United States, 68124
GSK Investigational Site
Papillion, Nebraska, United States, 68046
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
GSK Investigational Site
Sylvania, Ohio, United States, 43560
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29407
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37909
United States, Texas
GSK Investigational Site
Waco, Texas, United States, 76712
United States, Wisconsin
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209
GSK Investigational Site
West Allis, Wisconsin, United States, 53227
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: NCT00502775     History of Changes
Other Study ID Numbers: FFU109047
Study First Received: July 17, 2007
Results First Received: November 17, 2008
Last Updated: August 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
allergic rhinitis
ragweed
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 July 28, 2014