NCT06989333尚未招募2 期
A Single-arm Clinical Study of Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis
Jiuwu Bai0 个研究点目标入组 10 人开始时间: 2025年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Chest HRCT
研究概览
简要总结
This study aims to explore a new therapeutic approach: the feasibility, safety and preliminary efficacy of directly spraying GM-CSF into the airway through bronchoscopy for the treatment of aPAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 60 years old;
- •A clear diagnosis of aPAP must meet at least one of the following diagnostic criteria:
- •BALF appears "milky white"; Or cytological examination reveals a large amount of PAS-positive protein deposition; 2) HRCT shows typical "paving stone-like changes"; 3) Positive for serum GM-CSF antibody.
- •There are more than one of the following treatment indications: Symptoms such as progressive breathing difficulties, coughing, and shortness of breath after activity occur; 2) Without oxygen inhalation, PaO2 > 65 mmHg 3) Pulmonary function DLCO accounts for % of the predicted value, ranging from 60% to 80%, including the critical value.
- •No other PAP specific treatments (such as WLL, inhaled GM-CSF, biological agents, etc.) have been received recently (for more than 4 weeks).
- •Agree to participate in this study and sign the informed consent form.
排除标准
- •Secondary PAP (such as secondary to blood diseases, etc.);
- •Patients with obvious pulmonary fibrosis, emphysema or irreversible lung function impairment;
- •Patients in the acute exacerbation stage;
- •Patients with other lung diseases (such as active pulmonary tuberculosis, bronchiectasis with purulent infection or other chronic infections; Have severe asthma, chronic bronchospasm, etc.
- •Have a history of allergy to GM-CSF antibodies or related drug components;
- •Patients who have participated in other clinical drug trials within the past three months;
- •Patients who have experienced severe complications related to bronchoscopy or are intolerant to bronchoscopy;
- •Concurrent with other serious cardiovascular and cerebrovascular diseases, hematological disorders, malignant tumors, etc.
- •Pregnant or lactating women.
研究组 & 干预措施
Spraying GM-CSF
Experimental
干预措施: GM-CSF (granulocyte-macrophage colony-stimulating factor) (Drug)
结局指标
主要结局
Chest HRCT
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Jiuwu Bai
associate chief physician
Shanghai Pulmonary Hospital, Shanghai, China
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