A clinical trial conducted in patients with autoimmune pulmonary alveolar proteinosis (aPAP) revealed that daily administration of inhaled molgramostim resulted in greater improvements in pulmonary gas transfer and functional health status than placebo, according to an article published in the New England Journal of Medicine.
The analysis included 138 patients randomised to receive 300 μg inhaled molgramostim either continuously (n=46) or intermittently (n=45), or matching placebo (n=47) during a 24-week intervention period.
The primary endpoint was the change from baseline in the alveolar-arterial difference in oxygen concentration (A-aDo2) at week 24. Key secondary endpoints included the mean change from baseline to week 24 in functional health status and distance covered on the six-minute walk test.
The results show that patients receiving continuous molgramostim had greater improvement than those receiving placebo, for primary and secondary endpoints. Continuous molgramostim also resulted in greater improvement than intermittent molgramostim.
The three groups had similar rates of adverse effects, except for the percentage of patients with chest pain, which was higher in the continuous molgramostim group.
These findings suggest that daily administration of inhaled molgramostim resulted in benefits for aPAP patients.