Part A of this study will compare the effects of Clofazimine Inhalation Suspension to placebo. The purpose of this study is to find out if Clofazimine Inhalation Suspension can treat NTM lung disease by getting rid of the bacteria from the lungs and to make sure that Clofazimine Inhalation Suspension is safe for use. The participant will continue with current treatment for NTM lung disease in this study. To test if the bacteria are gone from the lungs, sputum will be tested on a regular basis (every month) to see if the culture changes from positive to negative. Participants will be randomly assigned by chance (like drawing numbers from a hat) to either Clofazimine Inhalation Suspension or placebo.
After the participant completes the study treatment in Part A, they will be eligible to receive Clofazimine Inhalation Suspension in Part B.
Approximately 234 participants will take part in the study at approximately 120 sites globally.
The study includes both a retrospective cross-sectional and prospective longitudinal cohort study design. Demographic and clinical data will be obtained through medical record review. 3-4 blood draws will be collected over the course of the study. If participants were also in the MAC2v3 or NTM PRO Cohort study, data collected for that study will be used in this study. About 450 subjects are expected to participate in this study at 7 research sites in the United States. Participation in this study is expected to last up to 12 months. During that time, participants will have about 3-4 study visits.
Subjects prescribed with the LibAirty system will be instructed to perform daily therapy sessions per standard device use recommendations. During the study period, subjects will be followed according to standard of care procedures and timelines for Bronchiectasis management. Clinical outcomes and healthcare resource utilization during the study period will be collected and compared to the 12-month period prior to study enrollment. Adherence to therapy will be evaluated by device recorded logs. Health related quality of life and subject satisfaction with the system will be evaluated by designated questionnaires, collected during clinic visits. Subjects will be followed for 12 months after starting therapy. Each subject will be required to complete a screening and enrollment visit, and any scheduled follow up visits according to standard of care timelines through 12 months (with data expected to be collected at 6 and 12 (±1m) months at minimum). Up to one hundred (100) subjects older than 21 years of age, with bronchiectasis who meet the entry criteria will be enrolled to the study, in up to ten (10) sites.