ClinicalTrials.gg
Not yet recruitingNCT07817134Updated Sep 14, 2026

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

A Phase 4 interventional study of Fluticasone propionate in Rhinitis Allergic and Rhinitis Seasonal, sponsored by HALEON. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by HALEON · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Rhinitis Allergic
  • Rhinitis Seasonal
03

In context

Rhinitis, Allergic, Perennial

178 studies on the registry are indexed under Rhinitis, Allergic, Perennial; 9 are open to participants now.

This study's planned enrollment of 16 is below the median of 135 across 157 interventional studies indexed under Rhinitis, Allergic, Perennial.

Browse Rhinitis, Allergic, Perennial studies →

Lead sponsor

HALEON is the lead sponsor of 64 studies on the registry; 9 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must give their signed and dated written 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 , in addition to having a negative pregnancy test at Visit 1, must be willing to use a form of 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 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.

Exclusion criteria

Exclusion Criteria:

  • An employee of the 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 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 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 .
  • 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 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 () inhibitors (ketoconazole, itraconazole, ritonavir, cobicistat containing products).
  • A participant who is or (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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Test Group

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

06

What researchers measure

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 8

Secondary 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 8

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07817134
Lead sponsor
HALEON
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 14, 2026

Study contacts

Haleon Response Center
Contact
ww.clinical-trial-register@haleon.com
+441932 95 95 00

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Fluticasone

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