This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).
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.
This is a prospective, multicenter open-label study in adults with CF who are colonized with NTM. Subjects will receive two 5-day infusion cycles of IV gallium. The study will evaluate the safety and antimycobacterial effect of two 5-day infusions of IV gallium. Subjects will be on study for up to 148 days, with a screening period of up to 7 days and active study period up to 20 days. About 40 people with CF who are 18 years of age or older will take part in this study at about 10 hospitals and clinics around the country.
The purpose of this study is to evaluate the effect and safety of amikacin liposome inhalation suspension (ALIS) study treatment on patient-reported symptoms in subjects newly diagnosed with NTM lung infection caused by MAC who have not started standard treatment. Around 250 subjects 18 years and older with newly diagnosed NTM lung infection caused by MAC who have not started standard treatment are expected to participate in this study. The study will last around 17.5 months from the Screening visit to the end of the study.
Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).
If you have been diagnosed with NTM, then your doctor may decide that this infection can be treated with Lamprene®/Clofazimine. This medicine is provided to you in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because you have a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because you have had side effects that prevent the use of other drugs.