Phase
Condition
Allergy
Common Cold
Acute Rhinitis
Treatment
Allergenic Extract Standardized Cat Hair Acetone-Precipitated (AP)
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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
- Have a TNSS of greater than or equal to 8/12 and at least a 50% drop in PNIF inresponse 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 atvisit 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 responseto the highest allergen concentration at visit 1.
Exclusion
Exclusion Criteria:
Participant has abnormalities detected on physical examination considered by theinvestigator to be clinically significant.
Participant has a history of any disease or disorder that, in the judgement of theinvestigator, 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 ofthe 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 seasonalallergen that is present in the outdoor environment during visit 1 and visit 2 andwhich the Principal Investigator judges would impact the outcome of the study.
Participant has any structural nasal abnormalities or nasal polyps on examination ora history of frequent nose bleeding, as determined by a nasal examination atscreening 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 weeksprior to the NAC visit.
Participant exhibits any signs or symptoms of a respiratory infection prior to anyvisit, as per Principal Investigator judgement.
Participant reports a TNSS of greater than or equal to 4 prior to the titrationchallenge at visit 1 or immediately prior to allergen challenge at visit 2, as perPrincipal Investigator judgement.
Participant reports a TNSS change of greater than 2 from baseline, after the diluentchallenge at visit 1.
Participants with asthma requiring the use of a short-acting beta agonist greaterthan twice a week (unless for viral asthma) or with severe asthma requiringmaintenance 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 onlow-dose inhaled corticosteroids or PRN inhaled corticosteroid/long-actingbeta-agonist as per Principal Investigator discretion.
Participant is currently receiving cat allergen specific immunotherapy or concludeda course of cat immunotherapy in the last 3 years.
Participant has a history of positive test results for HIV, Tuberculosis (not due tovaccination), 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 overthe duration of the study. Participant is unwilling to attend study visits or adhereto the study protocol, in the judgement of the Principal investigator.
Study Design
Study Description
Connect with a study center
Kingston Health Sciences Centre - Kingston General Hospital
Kingston, Ontario K7L2V7
CanadaActive - Recruiting
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