Last updated: 11/04/2018 07:18:00

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

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GSK study ID
FFU109045
See study documents
Clinicaltrials.gov ID
NCT00435461
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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 this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline over the two-week treatment period in Nighttime Symptoms Score (NSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Secondary outcomes:

Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in D-rTNSS

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from baseline over the two-week treatment period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline over the two-week treatment period in Peak NasalIinspiratory Flow (PNIF)

Timeframe: Baseline (Day 1) and up to 2 Weeks

Mean change from Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)

Timeframe: Baseline (Day 1) and Day 15

Interventions:
Drug: Fluticasone furoate and fexofenadine
Enrollment:
1000
Observational study model:
Not applicable
Primary completion date:
2007-28-02
Time perspective:
Not applicable
Clinical publications:
Andrews C, Martin B, Jacobs R, Toler T, Prillaman B, Philpot E. Efficacy of fluticasone furoate nasal spray versus oral fexofenadine on nighttime sleep disturbance caused by seasonal allergic rhinitis (SAR) nasal symptoms. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A6 (abstract)
Andrews CP, Martin BG, Jacobs RL, Diaz J, Toler WT, Prillaman BA, Dalal AA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvement in nocturnal quality of life in subjects with seasonal allergic rhinitis compared with oral fexofenadine. J Allergy Clin Immunol 2008;121(2) (Supplement 1): S53 (abstract)
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
Martin BG, Andrews CP, Jacobs R, Mohar D, Toler WT, Prillaman BA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvements in relieving nighttime nasal symptoms and increasing peak nasal inspiratory flow versus oral fexofenadine in subjects with seasonal allergic rhinitis (SAR) J Allergy Clin Immunol 2008;121(2) (Supplement 1): S54-S55 (abstract)
Medical condition
Rhinitis, Allergic, Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
December 2006 to February 2007
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Informed consent.
  • Outpatient.
  • Significant concomitant medical condition.
  • Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
Inclusion and exclusion 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

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Austin, Texas, United States, 78731
Status
Study Complete
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Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Study Complete
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Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
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Location
GSK Investigational Site
Kerrville, Texas, United States, 78028
Status
Study Complete
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Location
GSK Investigational Site
Austin, Texas, United States, 78750
Status
Study Complete
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Location
GSK Investigational Site
New Braunfels, Texas, United States, 78130
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2007-28-02
Actual study completion date
2007-28-02

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.

Additional information about the trial

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