Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
Status:
Completed
Trial end date:
2021-01-14
Target enrollment:
Participant gender:
Summary
Clinical trial for subjects with autoimmune pulmonary alveolar proteinosis (aPAP) who have
completed the IMPALA trial (NCT02702180).
At the Baseline visit, eligible subjects may continue or re-start treatment with 300 µg
inhaled molgramostim (recombinant human Granulocyte-Macrophage Colony Stimulating Factor;
GM-CSF) administered intermittently in cycles of seven days molgramostim, administered once
daily, and seven days off treatment.
Subject will be treated with inhaled molgramostim for up to 36 months.
During the trial, whole lung lavage will be applied as rescue therapy.