At a glance
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A Randomised, Double-blind, Placebo-controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients
In Brief
A Phase 2 clinical trial evaluating Molgramostim, Placebo, and 1 other intervention for Autoimmune Pulmonary Alveolar Proteinosis. Completed, enrolled 139 participants across 30 sites in 18 countries.
Detailed Summary
This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor \[rhGM-CSF\]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.
Study Details
Timeline
Interventions
300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation
Placebo nebulizer solution for inhalation
PARI eFlow nebulizer system