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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Haleon Response Center contact

+441932 95 95 00

ww.clinical-trial-register@haleon.com

Canada1 site

  • Cliantha Research

    Mississauga, Ontario

    Patricia Couroux

Other trials in Canada

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.

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 groups in NCT07817134
Study groupRoleWhat they receive
Test GroupExperimentalParticipants 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.

  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.

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

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    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.

  1. First posted14 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluticasone propionate in people with Rhinitis Allergic and Rhinitis Seasonal, run by HALEON at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haleon Response Center (+441932 95 95 00, ww.clinical-trial-register@haleon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visualization of Facial Allergy Symptoms (time frame: Baseline (Day 1) and Days 2, 3, 5 and 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07817134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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