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

Launched by QUEEN'S UNIVERSITY · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a cat allergen extract called Allergenic Extract Standardized Cat Hair Acetone Precipitated (AP Cat) to see if it can cause allergic rhinitis, which is a condition that makes people sneeze and have a runny nose when they are exposed to allergens, like cat hair. The study will involve both people who are allergic to cats and those who are not. The main goals are to find out if AP Cat triggers nasal allergy symptoms when sprayed in the nose, and if it affects certain allergy-related markers in the blood and nasal fluid.

To participate, you need to be a healthy adult aged 18 to 70. If you're allergic to cats, you must have a history of allergy symptoms related to cats and a positive test result for cat allergens. If you're not allergic, you need to have tested negative for common allergens. Participants will visit the study site three times, where they will receive the allergen directly in the nose, provide nasal fluid and blood samples, and fill out questionnaires about their symptoms and cat exposure. This study is important because it will help researchers understand how cat allergens affect people, which could lead to better treatments for those with allergies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be considered for inclusion in this study, all participants must be:
• • 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.
• Exclusion Criteria:
• • 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.
• • Participant has a history of positive test results for HIV, Tuberculosis (not due to vaccination), Hepatitis B (not due to vaccination) or Hepatitis C.
• • Participant has received an investigational product within the previous 30 days.
• • Participant is unable and/or unlikely to comprehend and/or follow the protocol over the duration of the study. Participant is unwilling to attend study visits or adhere to the study protocol, in the judgement of the Principal investigator.