This study is designed to visualize the response to use of fluticasone propionate nasal spray (Flonase Allergy Relief) to relieve facial allergy symptoms in individuals with moderate to severe seasonal allergic rhinitis (SAR).
This is an open-label, single-site, single-arm, phase 4 study to assess the response to use of fluticasone propionate spray (Flonase Allergy Relief) to relieve facial allergy symptoms in participants with moderate to severe SAR. Up to 16 participants, with the aim to have an approximately equal representation of males and females, will be enrolled in the study to receive active treatment following baseline assessment of allergy symptoms. Participants will receive study treatment for a total of 8 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
Fluticasone propionate aqueous nasal spray (United States Pharmacopeia \[USP\]), 50 microgram (mcg)/metered spray.
Cliantha Research
Mississauga, Ontario, Canada
Visualization of Facial Allergy Symptoms
Digital photographs of a participant's face will be collected using VISIA imaging following use of nasal spray to assess any rhinitis symptoms.
Time frame: Baseline (Day 1) and Days 2, 3, 5 and 8
Change From Baseline in Total Nasal Symptom Score (TNSS)
The TNSS will be scored for 4 nasal symptoms: nose, nasal congestion, runny nose, and sneezing on a scale ranging from 0 to 3, where 0= None, 1= Mild, 2= Moderate and 3= Severe. Thus, TNSS score ranges from 0 to 12, where lower score indicates improvement in the symptoms. Change from baseline will be calculated by subtracting baseline score form the scores at indicated timepoints.
Time frame: Baseline (Day 1) and up to Day 8
Change From Baseline in Total Ocular Symptom Score (TOSS)
The TOSS will be scored for 3 eye symptoms: itchy eyes, watery eyes, and eye redness on a scale ranging from 0 to 3, where 0= None, 1= Mild, 2= Moderate and 3= Severe. Thus, TOSS score ranges from 0 to 9, where lower score indicates improvement in the symptoms. Change from baseline will be calculated by subtracting baseline score form the scores at indicated timepoints.
Time frame: Baseline (Day 1) and up to Day 8
Change From Baseline in Ocular Redness Score
An eye examination will be conducted by an investigator to assess ocular redness using the scores ranging from 0 to 3, where 0= None, 1= Mild, 2= Moderate and 3= Severe. Lower score indicates improvement in the symptoms. Change from baseline will be calculated by subtracting baseline score form the scores at indicated timepoints.
Time frame: Baseline (Day 1) and Days 2, 3, 5 and 8
Rhinosinusitis Quality of Life Questionnaire (RQLQ) Score
RQLQ Consists of total 28 questions related to activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional well-being. Each question will be scored on a scale ranging from 0 to 6, where 0= not troubled and 6= extremely troubled. Thus, total score ranges from 0 to 168, where lower score indicates improvement in quality of life.
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Time frame: Baseline (Day 1) and Day 8