ICoN-1: Inhaled Clofazimine for NTM

Trial Objectives

NTM, or nontuberculous mycobacteria, are bacteria naturally found in water or soil that may cause lung infections. The two most common bacteria causing this disease are called Mycobacterium avium complex (MAC) and Mycobacterium abscessus complex (MABSC). Researchers in the ICoN-1 study are testing if a new inhaled medication, Clofazimine Inhalation Suspension, can help treat people with lung infections caused by these bacteria.

Volunteers in this study will provide sputum samples so researchers can test which bacteria may be causing their NTM infection. Those with MAC or MABSC infections will be randomly selected to either receive nebulizer treatment with the study drug or a placebo (a medication containing no active ingredient) for the first 6-7 months. After that phase, all volunteers will receive treatment with the study drug.

During clinic visits, volunteers will receive physical exams, lung function tests and electrocardiograms (ECGs). They also will be asked questions about their health and diet, as well as any adverse health events they have experienced.