Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis
1 other identifier
interventional
680
1 country
42
Brief Summary
The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2007
Shorter than P25 for phase_4
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
March 20, 2009
CompletedDecember 9, 2016
October 1, 2016
3 months
July 17, 2007
November 17, 2008
October 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in the Nighttime Symptom Score (NSS)
Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.
Baseline and Weeks 1-2
Secondary Outcomes (11)
Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
Baseline and Weeks 1-2
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
Baseline and Weeks 1-2
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
Baseline and Weeks 1-2
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
Baseline and Weeks 1-2
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
Baseline and Weeks 1-2
- +6 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Albany, Georgia, 31707, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Normal, Illinois, 61761, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
Lafayette, Indiana, 47904, United States
GSK Investigational Site
South Bend, Indiana, 46617, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Louisville, Kentucky, 40215, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Novi, Michigan, 48375, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Plymouth, Minnesota, 55441, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Columbia, Missouri, 65203, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
St Louis, Missouri, 63110, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Warrensburg, Missouri, 64093, United States
GSK Investigational Site
Lincoln, Nebraska, 68505, United States
GSK Investigational Site
Omaha, Nebraska, 68124, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Papillion, Nebraska, 68046, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Sylvania, Ohio, 43560, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Knoxville, Tennessee, 37909, United States
GSK Investigational Site
Waco, Texas, 76712, United States
GSK Investigational Site
Greenfield, Wisconsin, 53228, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209, United States
GSK Investigational Site
West Allis, Wisconsin, 53227, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 18, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
December 9, 2016
Results First Posted
March 20, 2009
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.