drugset / Trial / NCT03597347

Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection

NCT03597347 ↗

Phase 2 Terminated 14 enrolled Savara Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.

Timeline

Start
2019-06-20
Primary completion
2020-10-02
Completion
2020-10-02

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment for trial stopped early due to limitations from COVID-19, additionally changes in the standard of care for CF patients during the study period resulted in confounding of the primary endpoint.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Molgramostim Protein / enzyme biologic 300 ug Inhaled