NL-OMON54288已完成不适用
Type 2 low asthma in obese and non-obese patients treated with Tezepelumab - POTENT Trail
ongziekten0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- 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.
排除标准
- •- 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
研究者
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