Status:
UNKNOWN
Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis
Lead Sponsor:
Dai Huaping
Conditions:
Pulmonary Alveolar Proteinosis
Treatment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ad...
Eligibility Criteria
Inclusion
- Comfirmed diagnosis of autoimmune pulmonary alveolar proteinosis
- Disease severity score (DSS) is 4-5
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03316651
Start Date
August 1 2016
End Date
December 1 2020
Last Update
October 20 2017
Active Locations (1)
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1
China Japan Friendship Hispital
Beijing, China, 100029