Type 2 low asthma in obese and non-obese patients treated with Tezepelumab

nknown0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•Age 18-75 years
•- Written informed consent
•- BMI >18 with weight >40kg at inclusion
•- Documented physician-diagnosed asthma for at least 12 months prior to inclusion (12% reversibility in FEV1 or positive histamine/methacholine provocation test)
•- Controller regime with medium- or high dosed ICS
•? Medium: =250µg and <500µg fluticasone daily
•? High: =500µg fluticasone daily
•? Or bio-equivalent dose of other type of ICS
•- Stable dose of controller medication other than ICS/LABA (leukotriene receptor inhibitors, theophylline, secondary ICS, LAMA, chromones)
•- Pre-BD FEV1 value of = 40%
•- ACQ = 1.5
•- T2 low profile:
•? Peripheral blood eosinophils < 150 cells/µL
•? FeNO < 20 ppb
•? No clinically proven allergen driven asthma
•? No need for maintenance OCS
•- =2 exacerbation events or =1 exacerbation with hospitalization in the 12 months prior to inclusion
•? Exacerbation: burst of OCS for at least 3 days
•- Reproduction:
•? Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from screening, and must agree to continue using such precautions for 16 weeks after the final dose of Tezepelumab.

•- Current smokers
•- Stopped smoking <6 months prior to inclusion but = 10 pack years
•- Use of immune modulatory drugs, Azithromycin, Montelukast and Theophylline
•- Concurrent or intercurrent disease that may compromise safety of the patient or may compromise the ability to participate in the trial
•- Concomitant respiratory disease that will interfere with the evaluation of the product or the interpretation of the results
•- Evidence of active liver disease
•- History of cancer
•- Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 15 days prior to first visit
•- Pregnant, breastfeeding or lactating females
•- Unwillingness or inability to follow the procedures outlined in the protocol

发起方

nknown