The purpose of this replicate study to FFU105927 is to provide data on subject preference of FFNS as compared with FPNS.
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105924)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
377
fluticasone propionate nasal spray
fluticasone furoate nasal spray
placebo nasal spray matching fluticasone propionate nasal spray
GSK Investigational Site
Scottsdale, Arizona, United States
Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods of Active Drug Nasal Sprays Versus Placebos
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Participants assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Participant could also choose "I have no preference."
Time frame: End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Participants assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Participant could also choose "I have no preference."
Time frame: End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
Participants assessed preference over ease of use for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Participant could also choose "I have no preference."
Time frame: End of Crossover Period (Day 22)
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placebo nasal spray matching fluticasone furoate nasal spray
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Mission Viejo, California, United States
GSK Investigational Site
Orange, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
North Andover, Massachusetts, United States
GSK Investigational Site
Jackson, Mississippi, United States
...and 14 more locations
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods
Time frame: End of Crossover Period (Day 22)
Comparision of Mean Change From Baseline Over Treatment Periods in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Comparision of Mean Change From Baseline Over Treatment Periods in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)