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Clinical Trial 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 Nontuberculous Mycobacterial (NTM) infection. Subject will be treated for 24-weeks with inhaled molgramostim and will be 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.


Clinical Trial Description

The study will comprise a Screening Visit, Baseline Visit, a 24-week treatment period and a 12-week follow up period. The Screening Visit (Visit 1) will be conducted up to 10 weeks prior to the Baseline Visit (Visit 2) to determine eligibility. Adult subjects with a history of chronic Nontuberculous Mycobacterial (NTM) infection with at least 2 positive cultures in the prior two years, of which at least one is within the last 6 months prior to Screening, will be considered for enrollment. Subjects should provide a positive NTM sputum culture at Screening to be eligible. Two subgroups of subjects will be recruited: - Group 1: Subjects who remain sputum culture positive while currently on a multidrug NTM guideline based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit. - Group 2: Subjects who remain sputum culture positive but have either stopped a multidrug NTM guideline based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or never started such treatment. The study will include 30 subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03421743
Study type Interventional
Source Savara Inc.
Contact
Status Completed
Phase Phase 2
Start date March 1, 2018
Completion date January 13, 2020

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