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
1,000
1 country
6
Brief Summary
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and 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 Dec 2006
Shorter than P25 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2007
CompletedFirst Posted
Study publicly available on registry
February 15, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2007
CompletedResults Posted
Study results publicly available
February 5, 2018
CompletedMarch 7, 2018
July 1, 2017
1 month
February 14, 2007
February 21, 2017
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS)
The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night which were rated using three 4-point scales, the sum of which comprises NSS. The total score ranged from 0 (best) to 9 (worst). The symptoms were: PM nasal congestion upon awakening (PMNCA) (0- None, 1- Mild, 2- Moderate, 3- Severe), difficulty in going to sleep due to nasal symptoms (DSNS) (0- Not at all, 1- Little, 2- Moderately, 3- Very), and nighttime awakenings due to nasal symptoms (NANS) (0- Not at all, 1- Once, 2- More than once, 3- I felt like I was awake all night). Each participant's Baseline NSS was defined as the average of the NSS calculated for the day of randomization and the three highest NSS scores calculated during the six days immediately prior to the day of randomization. Each participant's average change from Baseline NSS for Weeks 1-2 was the participant's average NSS over the treatment period minus the participant's Baseline NSS.
Baseline (Day 1) and up to 2 Weeks
Secondary Outcomes (9)
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score
Baseline (Day 1) and up to 2 Weeks
Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS
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
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)
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)
Baseline (Day 1) and up to 2 Weeks
- +4 more secondary outcomes
Interventions
Fluticasone furoate and fexofenadine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (6)
GSK Investigational Site
Austin, Texas, 78731, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Kerrville, Texas, 78028, United States
GSK Investigational Site
New Braunfels, Texas, 78130, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (4)
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)
BACKGROUNDAndrews 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)
BACKGROUNDAndrews 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 Mar-Apr;30(2):128-38. doi: 10.2500/aap.2009.30.3204.
PMID: 19463203BACKGROUNDMartin 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)
BACKGROUND
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
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2007
First Posted
February 15, 2007
Study Start
December 20, 2006
Primary Completion
February 1, 2007
Study Completion
February 28, 2007
Last Updated
March 7, 2018
Results First Posted
February 5, 2018
Record last verified: 2017-07
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.