A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis

NCT07817134 | Not Yet Recruiting Phase 4

• 1 other identifier: 400366
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Rhinitis Seasonal; Rhinitis Allergic

Outcome Measures

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.

  Baseline (Day 1) and Days 2, 3, 5 and 8

Secondary Outcomes (4)

• Change From Baseline in Total Nasal Symptom Score (TNSS)

  Baseline (Day 1) and up to Day 8

• Change From Baseline in Total Ocular Symptom Score (TOSS)

  Baseline (Day 1) and up to Day 8

• Change From Baseline in Ocular Redness Score

  Baseline (Day 1) and Days 2, 3, 5 and 8

• Rhinosinusitis Quality of Life Questionnaire (RQLQ) Score

  Baseline (Day 1) and Day 8

Study Arms (1)

Test Group

EXPERIMENTAL

Participants will be instructed to administer two sprays of fluticasone propionate aqueous nasal spray in each nostril, once daily for 8 days.

Drug: Fluticasone propionate

Interventions

Fluticasone propionate DRUG

Fluticasone propionate aqueous nasal spray (United States Pharmacopeia \[USP\]), 50 microgram (mcg)/metered spray.

Test Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Minimum TNSS of more than or equal to (\>=)6 out of a possible 12 at Visit 1 (Baseline Visit).
• Visual facial allergy symptoms, such as infraorbital darkening, eye redness, eyelid swelling and facial erythema, as assessed by the Investigator or designee at Visit 1.
• Women of childbearing potential, in addition to having a negative pregnancy test at Visit 1, must be willing to use a form of birth control during the study.
• Male volunteers must agree to either abstain from sexual intercourse or use an acceptable method of birth control from Visit 1 until 30 days after the last study procedure.
• Participant in good general health, with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon physical examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.

You may not qualify if:

• 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.
• A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
• A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients.
• A participant who has never used nasal sprays before.
• Any surgery within 3 months before Visit 1 that, in the opinion of the Investigator, would compromise participant safety or integrity of the study data.
• Use of prohibited medications without appropriate washout.
• Has facial bruising, swelling, scarring, or discoloration (e.g., sunburn, face tattoos).
• Participants who cannot avoid activities that could lead to facial bruising, swelling, scarring or discoloration (e.g., martial arts, contact sports, cosmetic procedures, face tattoos) during the study period.
• Participants who cannot avoid prolonged exposure to natural or artificial sunlight (such as ultraviolet (UV) light treatment, including tanning) during the previous 1 week prior to Visit 1 or those who cannot refrain from tanning (natural or artificial) with UV light until the end of the study (including sunlamps, tanning beds and natural tanning).
• Participants who cannot avoid chlorinated pools (that may cause chemical discoloration) during the previous 1 week prior to Visit 1 or those who cannot refrain from using chlorinated pools until the end of the study.
• Participants who cannot avoid strenuous physical activity leading to facial redness for 4 hours prior to photograph capture on clinic visit days.
• Participants who cannot refrain from changing any personal care products including cosmetics, sunscreens, soaps, shampoos, laundry detergent or fabric softener during the previous 2 weeks prior to Visit 1 and for the duration of the study.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Haleon Response Center

CONTACT

+441932 95 95 00; ww.clinical-trial-register@haleon.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

CA (1)