ACTIVE NOT RECRUITING
NCT06189742
Tezepelumab in Allergic Rhinitis and Asthma Study (TEZARS)
The goal of this clinical trial is to learn about how well tezepelumab (pronounced TEZ e PEL ue mab), a Health Canada-approved drug for severe asthma, works in participants with coexisting allergic asthma and allergic rhinitis (hayfever). The main questions it aims to answer are:
* How well does the study drug work to reduce nasal symptoms following exposure to an allergen after 6 doses, and after 12 doses?
* Does the study drug reduce chemicals found in the nose known to be involved in the allergic rhinitis response?
Both allergic and non-allergic participants will be enrolled in the study.
Non-allergic participants will:
* Not be receiving the study drug.
* Be exposed to allergen via the Nasal Allergen Challenge, which involves the administration of allergen extract directly to the nose.
* Complete nasal symptom and quality of life questionnaires
* Have nasal fluid and blood samples collected at various time points up to 24 hours following allergen exposure.
* Visit the clinic 3 separate times:
* At a screening visit to determine their eligibility to participate in the study
* At the baseline Nasal Allergen Challenge visit
* At the 24-hour post-Nasal Allergen Challenge follow-up visit
Allergic participants will:
* Receive one dose of tezepelumab every 1 month for 12 months. Tezepelumab will be administered as an injection into the fatty layer just beneath the skin on the stomach, arm, or thigh.
* Be exposed to allergen via the Nasal Allergen Challenge, which involves the administration of allergen extract directly to the nose.
* Complete nasal symptom and quality of life questionnaires
* Have nasal fluid and blood samples collected at various time points up to 24 hours following allergen exposure.
* Visit the clinic 17 separate times:
* At a screening visit to determine their eligibility to participate in the study
* At the baseline, 6-month, and 12-month Nasal Allergen Challenge visits
* At each 24-hour post-Nasal Allergen Challenge follow-up visit
* For each dose of the study drug
The investigator will compare changes in nasal symptoms and allergic chemicals measured from nasal fluid and blood samples between non-allergic participants and allergic participants at baseline and at 6- and 12-months following the use of the study drug.
Gender: All
Ages: 18 Years - 65 Years
Asthma With Allergic Rhinitis