Rhinitis AllergicPhase 4NCT07817134
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
A Phase 4 study testing Fluticasone propionate in people with Rhinitis Allergic and Rhinitis Seasonal, run by HALEON at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rhinitis Allergic, Rhinitis Seasonal
- What is being tested?
- Fluticasone propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Participants who cannot refrain from physical therapy (including massage, chiropractic, osteopathic manipulation, acupuncture) for 12 hours prior to photograph capture on clinic days.
- Unwilling to forego the use of, or remove make-up (including lotions, sunscreens) prior to photograph capture on clinic visit days.
- A participant with an active upper respiratory tract infection at screening.
- A participant who has or has had glaucoma or cataracts.
- A participant with asthma requiring regular inhaled corticosteroid therapy or asthma that, in the opinion of the investigator, may interfere with study conduct or interpretation.
- A participant with structural nasal defects or nasal polyps.
- A participant with injury or surgery to the nose that has not fully healed.
- Current use of potent Cytochrome P3A4 (CYP3A4) inhibitors (ketoconazole, itraconazole, ritonavir, cobicistat containing products).
- A participant who is immunosuppressed or Human Immunodeficiency Virus (HIV) positive.
- Past or present concomitant medical conditions, which as judged by the Investigator, may affect the outcome of this study.
- History of drug or alcohol abuse from 2 years prior to Visit 1 until the end of the current study.
- Has a positive test for drugs of abuse and/or alcohol at study check-in.
- Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
- A participant who has previously been enrolled in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open Label Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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).
Read the detailed description
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.
- Conditions
- Rhinitis Allergic, Rhinitis Seasonal
- Being tested
- Fluticasone propionate
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionateDrug
Fluticasone propionate aqueous nasal spray (United States Pharmacopeia [USP]), 50 microgram (mcg)/metered spray.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and Days 2, 3, 5 and 8
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817134
- Sponsor's protocol ID
- 400366
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com