This trial is shared by:
Insmed Incorporated (the study sponsor) is evaluating the safety and efficacy of the study drug ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) in patients with newly diagnosed mycobacterial (MAC) lung infections who have not started treatment. This study aims to evaluate if the ALIS-based combination treatment in adults with new MAC lung infections is safe and effective.
This study (also called a clinical trial) will include adults from around the world with MAC lung infections. Enrolled participants will be in the study for up to 18 months and will visit the study site regularly. The study sponsor may cover travel expenses related to the study visits for the participant in applicable countries only.
The purpose of this clinical trial is to evaluate an investigational drug for potential treatment of MAC lung infections and evaluate symptomatic improvement including effect on respiratory discomfort and fatigue. Participants will be randomly assigned into one of two groups:
If you are interested in joining this study, you will need to visit a clinical study site. A doctor will explain the study to you. If you agree to join, by reviewing and signing the Informed Consent Form (ICF), the doctors and study staff will perform an evaluation and ask you questions about your medical history to make sure you are eligible to take part in the study.
If eligible and you decide to join the study, you will be seen by MAC experts and may receive a study treatment being evaluated for:
Your participation in the trial will last up to 18 months and will include regular study visits.
Full details about the study, visits, and examinations will be discussed with you before you decide to participate in the study.
If you are interested in learning more about this study, take the following steps:
Insmed Incorporated, the study sponsor, may cover travel expenses related to your study visits in applicable countries and only if applicable. Examples of expenses:
Additional information on travel support will be provided by the site staff should you decide to participate.
You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:
Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases.