A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHALEON
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must give their signed and dated written informed consent to participate prior to commencing any study-related activities and must be willing to comply with study procedures and the study protocol.
Participant must sign and date the Participant Photo Release Form to agree to have the photographs and images generated during the study be used for promotional and/or marketing purposes by the Sponsor.
Medical history of seasonal allergic rhinitis/rhinoconjunctivitis in the past two years.
Willingness to use a nasal spray.
Disqualifiers
An employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
A participant who has taken part in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
A participant who, in the opinion of the investigator or medically qualified designee, should not participate in this study.
A participant who is not willing to have their images used for applications as outlined within the Informed Consent Form and Participant Photo Release Form.
Trial design
Design model
Single group
Treatments tested in this trial
Fluticasone propionate
DrugFluticasone propionate aqueous nasal spray (United States Pharmacopeia \[USP\]), 50 microgram (mcg)/metered spray.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Test GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 8Secondary outcomes
1
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 82
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 83
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 84
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.
Time frame
Baseline (Day 1) and Day 8 Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: