CTIS2024-514843-27-00招募中1 期
Predictive Signature of Benralizumab Response. BENRAPRED Study. - RC19_0292
Centre Hospitalier Universitaire De Nantes0 个研究点目标入组 220 人开始时间: 2024年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
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 65+（—）
- 性别
- All
入选标准
- •Patients between 18 and 75 years old, Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e.: asthma requiring high doses of ICS (>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to be controlled over one year, and/or uncontrolled asthma despite the later medications, and/or a controlled asthma worsening after decreasing medications, Documented historical reversibility of FEV1 =12% and FEV1 gain = 200mL, ACQ-7 score = 1,5 at M0, At least 3 exacerbations in the 12 months prior to inclusion visit M0, Eosinophil blood count = 0,3 G/L at inclusion visit or in the 12 months prior to the inclusion visit. If eosinophil blood count is = 0,15 G/L and < 0,3 G/L, an eosinophilic phenotype defined by at least 1 of the following criteria will be required: FeNO > 25 ppm at inclusion visit or in the 12 months prior to the inclusion visit, or/andSputum eosinophils at leat 3% at inclusion visit or in the 12 months prior to the inclusion visit, Patient who has never received treatment with Benralizumab before prior to participation in the study, Patients who provide written informed consent prior to participation in the study
排除标准
- •Patients diagnosed with difficult-to-treat asthma and/or with uncontrolled asthma differential diagnosis according to the judgment of the investigator (e.g., vocal cord dysfunction, gastroesophageal reflux disease, granulomatous eosinophilic vasculitis, obstructive sleep apnea syndrome, hyperventilation syndrome, allergic broncho-pulmonary aspergillosis, Carrington disease, DIPNECH, asthma/COPD overlap syndrome)., Patients requiring other biotherapy than Benralizumab that affects the immune system, SARS-COV2 infection, Pregnancy, lactation, or patients with childbearing potential refusing efficient contraceptive method., Patients under psychiatric condition altering their comprehension and their ability to give informed consent., Patients already enrolled in a clinical interventional research., Patients not affiliated to a health insurance plan, Patients under guardianship, curatorship or safeguard of justice, Non-adherent patients to inhaled treatment (ICS + LABA)., Active smokers or former smokers exceeding 20 packs year., Exacerbation at inclusion visit M0, Active malignancy or malignancy in remission over less than 5 years., Active parasitic infection or parasitic infection in the past 24 weeks., Hypersensitivity to Benralizumab or to any of the excipients of Fasenra® (histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20), Patients requiring other immunosuppressive and immunomodulator drugs, Patients requiring other biotherapy than Benralizumab, with or without French’s marketing authorisation in severe asthma
研究者
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