At a glance
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An Open-label, Non-controlled, Multicentre, Pilot Clinical Trial of Inhaled Molgramostim in Subjects With Antibiotic-resistant Non-tuberculosis Mycobacterial (NTM) Infection
In Brief
A Phase 2 clinical trial evaluating Inhaled molgramostim and Antimycobacterial regimen for Mycobacterium Infections, Nontuberculous. Completed, enrolled 32 participants across 5 sites in 2 countries.
Detailed Summary
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary non-tuberculous mycobacterial (NTM) infection. Participants will be treated for 24-weeks with inhaled molgramostim and followed up for 12-weeks after end of treatment. The primary aim of the trial is to investigate the efficacy of inhaled molgramostim on NTM sputum culture conversion to negative.
Study Details
Timeline
Interventions
300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Multidrug NTM guideline-based antimycobacterial regimen