Rhinitis Allergic, Rhinitis Seasonal
Conditions
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).
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.
Interventions
DRUGFluticasone propionate
Fluticasone propionate aqueous nasal spray (United States Pharmacopeia \[USP\]), 50 microgram (mcg)/metered spray.
Sponsors
HALEON
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visualization of Facial Allergy Symptoms | Baseline (Day 1) and Days 2, 3, 5 and 8 | Digital photographs of a participant's face will be collected using VISIA imaging following use of nasal spray to assess any rhinitis symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score (TNSS) | Baseline (Day 1) and up to Day 8 | 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. |
| Change From Baseline in Total Ocular Symptom Score (TOSS) | Baseline (Day 1) and up to Day 8 | 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. |
| Change From Baseline in Ocular Redness Score | Baseline (Day 1) and Days 2, 3, 5 and 8 | 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. |
| Rhinosinusitis Quality of Life Questionnaire (RQLQ) Score | Baseline (Day 1) and Day 8 | 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. |
Countries
Canada
Contacts
CONTACTHaleon Response Center
Outcome results
None listed