Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT06989333
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 to 60 years old;
2. 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 Criteria:
1. Secondary PAP (such as secondary to blood diseases, etc.);
2. Patients with obvious pulmonary fibrosis, emphysema or irreversible lung function impairment;
3. Patients in the acute exacerbation stage;
4. Patients with other lung diseases (such as active pulmonary tuberculosis, bronchiectasis with purulent infection or other chronic infections; Have severe asthma, chronic bronchospasm, etc.
5. Have a history of allergy to GM-CSF antibodies or related drug components;
6. Patients who have participated in other clinical drug trials within the past three months;
7. Patients who have experienced severe complications related to bronchoscopy or are intolerant to bronchoscopy;
8. Concurrent with other serious cardiovascular and cerebrovascular diseases, hematological disorders, malignant tumors, etc.
9. Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06989333
Study Brief:
Protocol Section:
NCT06989333