Full Text View
Tabular View
Study Results
Related Studies
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
This study has been completed.
First Received: July 17, 2007   Last Updated: August 20, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00502775
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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)
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502775

  Show 41 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: FFU109047
Study First Received: July 17, 2007
Results First Received: November 17, 2008
Last Updated: August 20, 2009
ClinicalTrials.gov Identifier: NCT00502775     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Fexofenadine
Fluticasone
Dermatologic Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Histamine Agents
Anti-Asthmatic Agents
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Terfenadine
Histamine Antagonists
Autonomic Agents
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 27, 2009