Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects (NCT03414801) | Clinical Trial Compass
CompletedNot Applicable
Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects
Canada6 participantsStarted 2018-02-06
Plain-language summary
To assess the reproducibility of the allergic response in the cat allergic subjects, measured as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge days.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Allergic Subjects:
* Male and female adults, 18 years to 65 years of age
* Willing and able to give informed consent for participation in the study.
* Otherwise healthy with a diagnosis of perennial allergic rhinitis and a clinical history of nasal symptoms during exposure to cat in the previous 2 years
* With positive skin prick test reactivity to cat dander. A positive skin prick test is a wheal ≥3 mm larger than the negative control performed at the screening visit or within 6 months of the screening visit provided that complete documentation (specific allergen used for the SPT and the size of the reaction) is available
* Having sufficient rhinoconjunctivitis symptoms (TRCSS score ≥5) during the first cat challenge
* If subjects are taking medications (other than allergy medications), the dosing must be stable for at least 4 weeks prior to study entry
* With laboratory results at the screening visit which, in the opinion of the investigator, are clinically acceptable for the subject to be enrolled in the study
* Able (in the investigators opinion) and willing to comply with all study requirements
Exclusion Criteria for Allergic Subjects:
* Subjects with a cat at home or who are regularly exposed to cats during the study period
* Subjects with a diagnosis of asthma with the exception of mild intermittent asthma defined as normal lung function and intermittent treatment with a short-acting beta agonist only
* Subjects with a history of anaphylactic …
What they're measuring
1
Difference in Total Nasal Symptom Score (TNSS) change from baseline to the end of the challenge between the two challenge days (Visits 2 and 3) in the cat-allergic subjects