Allergenic Extract Standardized Cat Hair AP in an Allergic Rhinitis Model. (NCT06828484) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Allergenic Extract Standardized Cat Hair AP in an Allergic Rhinitis Model.
Canada20 participantsStarted 2025-03-04
Plain-language 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:
1. Does AP Cat induce nasal symptoms of allergic rhinitis in cat-allergic participants when delivered intranasally?
2. Does AP Cat reduce elements in the blood and nose that are known to be associated with allergies?
Both allergic and non-allergic participants will be recruited into this study.
Allergic participants will:
* 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:
1. At screening (Visit 1), to determine eligibility to participate in this study
2. At the baseline NAC visit (Visit 2)
3. 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:
1. At screening (Visit 1), to determine eligibility to participate in this study
2. At the baseline NAC visit (Visit 2)
3. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
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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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.