Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effectiveness of the sequential therapy with whole lung Lavage (WLL)/inhaling granulocyte-macrophage colony stimulating factor, compared to WLL only, for adult patients with severe autoimmune pulmonary alveolar proteinosis in China over a two-year period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dai Huaping

Criteria

Inclusion Criteria:

• Comfirmed diagnosis of autoimmune pulmonary alveolar proteinosis

• Disease severity score (DSS) is 4-5

Exclusion Criteria:

• The acute respiratory infection

• Heart failure (such as cardiogenic pulmonary edema)

• The serious liver and kidney dysfunction (creatinine or ALT were equal to or more than 2 times of the upper limit of normal range);

• Pregnancy;

• The patients with hereditary and secondary factors (inhalation of dust, hematological diseases, autoimmune diseases, etc.);

• DSS is 1-3;

• The patient is allergic to the drugs that be used in our research;

• The patients with poor compliance, or suffering from mental illness;

• The patients have not signed informed consent;

• They were treated with whole lung lavage or regular GM-CSF therapy (treatment for more than 2 weeks) within 3 months before the enrollment.