A Prescreening Study to Diagnose Allergic Bronchopulmonary Aspergillosis in Selected Patients With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Patients Invited
研究概览
简要总结
This prescreening study is being conducted to diagnose ABPA in selected patients with asthma and to increase the potential number of eligible participants for the ongoing Study 601-0018 of PUR1900 in subjects with ABPA. See: NCT05667662.
Additionally, this prescreening study may provide information that could assist the conduct of future studies conducted by Pulmatrix.
详细描述
See NCT05667662 for a detailed description fo the main ABPA study. This prescreening study is designed to diagnose ABPA in patients with asthma to potentially increase the number of eligible participants for the ongoing NCT05667662 study. This diagnosis will be confirmed through chest x-rays and a blood sample.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent before the performance of any study-specific procedures at the in-clinic visit.
- •Is a male or female ≥18 years old.
- •Has a BMI of ≥18.0 and <40.0 kg/m2 at the in-clinic visit.
- •Meets the following criteria:
- •Has a diagnosis of asthma.
- •At least 1 exacerbation requiring a systemic glucocorticosteroid(s) or hospital admission in the last 10 months.
- •For patients on a biologic agent, at least one exacerbation requiring a systemic glucocorticosteroid(s) or hospital admission must have occurred at least 3 months after the initiation of the biologic agent.
- •Is willing and able to comply with all study procedures
排除标准
- •Has used omalizumab (Xolair®) in the 11 months prior to screening or plans to use omalizumab during the study.
- •Has a current diagnosis of any chronic airway disease other than asthma, ABPA, or bronchiectasis believed to be related to ABPA, such as chronic obstructive pulmonary disease, pulmonary fibrosis, CF, or Churg-Strauss syndrome.
- •Currently requiring medications that are sensitive substrates for CYP3A4-mediated metabolism or medications that are contraindicated during and 2 weeks after treatment with oral formulations of itraconazole without the possibility of washout (See Appendix 4).
- •Smoking marijuana or tobacco, the use of e-cigarettes, vaping, or any other smoking is prohibited during the study.
结局指标
主要结局
Patients Invited
时间窗: 6 weeks
Number of patients invited to participate in Study 601-0018
Patients Diagnosed
时间窗: 6 weeks
Number of patients with known asthma and diagnosis of ABPA
次要结局
未报告次要终点