Allergenic Extract Standardized Cat Hair AP in an Allergic Rhinitis Model.

NCT06828484 | Active Not Recruiting

• 1 other identifier: AP-CAT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if a cat allergen extract known as Allergenic Extract Standardized Cat Hair Acetone Precipitated (AP Cat) can induce allergic rhinitis (AR) in a nasal allergen challenge model in cat-allergic people. The main questions this study aims to answer are:

• Be challenged with AP Cat via the Nasal Allergen Challenge (NAC), which involves administration of this allergen extract directly into the nose.
• Have nasal fluid and blood samples collected at various timepoints up to 24 hours after exposure to the allergen in the NAC.
• Visit the study site three separate times:
• At screening (Visit 1), to determine eligibility to participate in this study
• At the baseline NAC visit (Visit 2)
• At the 24-hour post-NAC follow-up visit (Visit 3)
• Complete nasal symptom questionnaires.
• Complete a questionnaire about their regular exposure to cats. Non-allergic participants will:
• Be challenged with AP Cat via the NAC, which involves administration of this allergen extract directly into the nose.
• Have nasal fluid and blood samples collected at various timepoints up to 24 hours after exposure to the allergen in the NAC.
• Visit the study site three separate times:
• At screening (Visit 1), to determine eligibility to participate in this study
• At the baseline NAC visit (Visit 2)
• At the 24-hour post-NAC follow-up visit (Visit 3)
• Complete nasal symptom questionnaires. This study will compare the nasal symptoms and allergic markers collected from the nasal fluid and blood samples between allergic and non-allergic participants at baseline and various timepoints post-NAC exposure.

Conditions

Allergic Rhinitis

Keywords

Allergy; Allergic Rhinitis; Perennial Allergies; Cat Allergies; Allergen Exposure Models; Nasal Allergen Challenge

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Score (TNSS)

  To evaluate the effect of NAC exposure to AP Cat on TNSS (where a score of 0 indicates no nasal allergic symptoms while a score of 12 indicates the maximum nasal symptoms) compared to baseline measures in cat-allergic participants.

  Pre-NAC up to 24 hours post-NAC.

Secondary Outcomes (12)

• Peak Nasal Inspiratory Flow (PNIF)

  Pre-NAC up to 24 hours post-NAC.

• Total Ocular Symptom Score (TOSS)

  Pre-NAC up to 24 hours post-NAC.

• Total Rhinoconjunctivitis Symptom Score (TRSS)

  Pre-NAC up to 24 hours post-NAC.

• Safety Outcome Scoring

  From enrolment to the final study visit.

• Concentration of alarmins (IL-17E/IL-25, IL-33) from serum.

  Screening, baseline, 3 hours post-NAC, 6 hours post-NAC, 24 hours post-NAC.

Other Outcomes (1)

• Skin Prick Test Wheal Diameter

  Screening, baseline, 3 hours post-NAC, 6 hours post-NAC, 24 hours post-NAC.

Study Arms (2)

Allergic Participant AP-Cat Challenge

EXPERIMENTAL

Drug: Allergenic Extract Standardized Cat Hair Acetone-Precipitated (AP)

Non-Allergic Participant AP-Cat Challenge

EXPERIMENTAL

Drug: Allergenic Extract Standardized Cat Hair Acetone-Precipitated (AP)

Interventions

Allergenic Extract Standardized Cat Hair Acetone-Precipitated (AP) DRUG

Cat-allergic and non-allergic participants will be exposed to AP Cat in the NAC.

Also known as: AP Cat

Allergic Participant AP-Cat Challenge; Non-Allergic Participant AP-Cat Challenge

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A healthy, ambulatory male, female, or intersex volunteer between the ages of 18 to 70 years of age.
• Able to understand and willing to provide written informed consent.
• Able and willing to comply with study requirements.
• To be enrolled as an allergic participant, participants must:
• Have a minimum 2-year history of AR symptoms upon exposure to cats.
• Have a positive skin prick response to AP cat allergen, defined as a wheal diameter ≥ 5 mm compared to the negative control wheal. This result must be achieved at visit 1.
• Have a TNSS of greater than or equal to 8/12 and at least a 50% drop in PNIF in response to the allergen titration challenge at visit 1.
• To be enrolled as a non-allergic participant, participants must:
• Produce a negative skin test response to a panel of relevant aeroallergens tested at visit 1 or within 12 months before visit 1 at the research site.
• Produce a negative Nasal Allergen Challenge, defined by a TNSS response of less than 4/12 and a PNIF reduction of less than or equal to 20% after 10 minutes in response to the highest allergen concentration at visit 1.

You may not qualify if:

• Participant has abnormalities detected on physical examination considered by the investigator to be clinically significant.
• Participant has a history of any disease or disorder that, in the judgement of the investigator, would impact the participant's safety or the results of the study.
• Participant has a significant history of alcohol or drug abuse in the judgment of the Principal Investigator or delegate.
• Participant is pregnant, lactating, or actively trying to become pregnant.
• Participant is unable to comply with the washout periods for restricted medications.
• Participant has signs/symptoms of active seasonal AR or is allergic to a seasonal allergen that is present in the outdoor environment during visit 1 and visit 2 and which the Principal Investigator judges would impact the outcome of the study.
• Participant has any structural nasal abnormalities or nasal polyps on examination or a history of frequent nose bleeding, as determined by a nasal examination at screening and prior to the NAC, in the judgement of the principal investigator.
• Participant has undergone nasal surgery within the previous 3 months before visit 1.
• Participant has experienced an upper or lower respiratory infection within 2 weeks prior to the NAC visit.
• Participant exhibits any signs or symptoms of a respiratory infection prior to any visit, as per Principal Investigator judgement.
• Participant reports a TNSS of greater than or equal to 4 prior to the titration challenge at visit 1 or immediately prior to allergen challenge at visit 2, as per Principal Investigator judgement.
• Participant reports a TNSS change of greater than 2 from baseline, after the diluent challenge at visit 1.
• Participants with asthma requiring the use of a short-acting beta agonist greater than twice a week (unless for viral asthma) or with severe asthma requiring maintenance high doses of inhaled or oral corticosteroids or biologic therapy (Omalizumab/Mepolizumab/Resilizumab).
• Participant has a history of cat allergen induced asthma, unless well controlled on low-dose inhaled corticosteroids or PRN inhaled corticosteroid/long-acting beta-agonist as per Principal Investigator discretion.
• Participant is currently receiving cat allergen specific immunotherapy or concluded a course of cat immunotherapy in the last 3 years.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston Health Sciences Centre - Kingston General Hospital

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Both allergic (Arm 1) and non-allergic (Arm 2) groups will receive the same intervention (AP Cat) through the NAC.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 14, 2025
• Study Start: March 4, 2025
• Primary Completion: January 8, 2026
• Study Completion: June 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)