jRCTs071230026进行中（未招募）不适用
Tezepelumab-induced Clinical Remission in Severe Asthma: a single-arm multicenter clinical trial (TERESA)
未提供0 个研究点目标入组 105 人开始时间: 2023年7月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Patients diagnosed with severe asthma by a respiratory physician and receiving middle- or high-dose inhaled glucocorticoids plus additional controller medication. (Patients treated with or without a history of biologics use, however, as long as possible more than 4 months elapsed between the last dose of the previous biological agent and the start of protocol treatment.)
- •2.Patients treated with systemic corticosteroids as maintenance therapy for asthma at a PSL equivalent of 5 mg/day or less.
- •3.Patients aged 20 years or older at the time of obtaining consent.
- •4.Patients with uncontrolled asthma who fulfill one of the following conditions.
- •i) History of at least one asthma exacerbation within 6 months before the date of obtaining consent
- •ii) 1.5< Asthma Control Questionnaire-6 (ACQ-6) score <=3.5 within 2 months before the date of consent
- •iii) 60% predicted <= FEV1 <80% predicted within 2 months before the date of obtaining consent
- •5.Patients who are able to provide informed written consent prior to enrolment in the study.
排除标准
- •Patients diagnosed with any clinically significant pulmonary diseases other than asthma (e.g., chronic obstructive pulmonary disease) or pulmonary or systemic diseases due to increased peripheral blood eosinophil counts (e.g., chronic eosinophilic pneumonia, allergic bronchopulmonary mycosis, eosinophilic granulomatosis with polyangiitis).
- •Patients diagnosed with a parasitic infection within 6 months before obtaining consent who were not treated with standard treatment or who did not respond to treatment.
- •Patients with comorbidities requiring systemic corticosteroids or immunosuppressive treatment.
- •Patients with a history of anaphylaxis or immune complex disease (type III hypersensitivity reaction) following treatment with biological agents.
- •Female patients who are pregnant or may become pregnant. Female patients who are lactating.
- •Patients deemed by the responsible physician to be unsuitable for the study.
结局指标
主要结局
-
Proportion of patients in clinical remission at 52 weeks of treatment.
次要结局
- Proportion of patients in clinical remission at 24, 72 and 104 weeks of treatment(24, 72 and 104 weeks)
- Proportion of patients in clinical remission at both 24 and 52 weeks of treatment or 52 and 104 weeks of treatment(24 and 52 weeks or 52 and 104 weeks)
- Proportion of patients in clinical remission at 24, 52, 76 and 104 weeks of treatment who were not receiving systemic corticosteroids as maintenance therapy on the date of initiation of treatment(24, 52, 76 and 104 weeks)
- Proportion of patients in complete remission at 24, 52, 76 and 104 weeks of treatment(24, 52, 76 and 104 weeks)
- Proportion of patients in complete remission at both 24 and 52 weeks of treatment or 52 and 104 weeks of treatment(24 and 52 weeks or 52 and 104 weeks)
- Proportion of patients in complete remission at 24, 52, 76 and 104 weeks of treatment who were not receiving systemic corticosteroids as maintenance therapy on the date of initiation of treatment(24, 52, 76 and 104 weeks)
- Change in type 2 biomarkers, symptoms and pulmonary function from baseline to 24, 52, 76 and 104 weeks of treatment(24, 52, 76 and 104 weeks)
- Proportion of patients in low disease activity at 24, 52, 76 and 104 weeks of treatment(24, 52, 76 and 104 weeks)
- Annual asthma exacerbation rates up to 52 and 104 weeks of treatment(52 and 104 weeks)
- Proportion of patients in clinical remission at all 24, 52, 76 and 104 weeks of treatment(24, 52, 76 and 104 weeks)
- Proportion of patients in complete remission at all 24, 52, 76 and 104 weeks of treatment(24, 52, 76 and 104 weeks)
- Classification of patients in low disease activity, clinical remission, complete remission or none at 52 and 104 weeks, and confirmation of the transition(52 and 104 weeks)
研究者
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