Last updated: 11/07/2018 16:52:37
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the treatment of seasonal allergic rhinitis
Trial description: The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Mean Change from Baseline in the Nighttime Symptom Score (NSS)
Timeframe: Baseline and Weeks 1-2
Secondary outcomes:
Mean Change from Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
Timeframe: Baseline and Weeks 1-2
Mean Change from Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
Timeframe: Baseline and Weeks 1-2
Mean Change from Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
Timeframe: Baseline and Weeks 1-2
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
Timeframe: Baseline and Weeks 1-2
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
Timeframe: Baseline and Weeks 1-2
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
Timeframe: Baseline and Weeks 1-2
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
Timeframe: Baseline and Weeks 1-2
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
Timeframe: Baseline and Weeks 1-2
Mean Change from Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
Timeframe: Baseline and Weeks 1-2
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
Timeframe: Baseline and Weeks 1-2
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
Timeframe: Baseline, Day 15 or if Early Withdrawal Day
Interventions:
Drug: fluticasone furoate, fexofenadine
Enrollment:
680
Observational study model:
Not applicable
Primary completion date:
2007-18-11
Time perspective:
Not applicable
Clinical publications:
Andrews CP, Martin BG, Jacobs RL, Mohar DE, Diaz JD, Amar NJ, Kaiser HB, Vandewalker ML, Bernstein J, Toler WT, Prillaman BA, Dalal AA, Lee LA, Philpot EE. Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy . Allergy Asthma Proc. 2009;30(2):128-38.
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
August 2007 to November 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Informed consent
- Otherwise healthy outpatient with mountain cedar allergy
- 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.
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Papillion, Nebraska, United States, 68046
Status
Study Complete
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29407
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Study Complete
Location
GSK Investigational Site
Warrensburg, Missouri, United States, 64093
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
Location
GSK Investigational Site
South Bend, Indiana, United States, 46617
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
West Allis, Wisconsin, United States, 53227
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73120
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Indiana, United States, 47904
Status
Study Complete
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37909
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Sunset, Louisiana, United States, 70584
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68505
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209
Status
Study Complete
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-18-11
Actual study completion date
2007-18-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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