Status:
NOT_YET_RECRUITING
Local Spraying of GM-CSF Via Bronchoscopy in the Treatment of Autoimmune Pulmonary Alveolar Proteinosis
Lead Sponsor:
Jiuwu Bai
Conditions:
Pulmonary Alveolar Proteinosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Age: 18 to 60 years old;
- A clear diagnosis of aPAP must meet at least one of the following diagnostic criteria:
- 1\) 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. 3. 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.
- 4\. No other PAP specific treatments (such as WLL, inhaled GM-CSF, biological agents, etc.) have been received recently (for more than 4 weeks).
- 5\. Agree to participate in this study and sign the informed consent form.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06989333
Start Date
July 1 2025
End Date
June 30 2027
Last Update
May 25 2025
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