This trial is shared by:
Refer to the National Clinical Trial (NCT) identifier number: NCT04677569
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 main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen. Enrolled participants will be in the study for up to 18 months and will visit the study site regularly.
Your patient will need to visit a clinical study site where a research staff and physician will explain the study to the patient. If they agree to participate by reviewing and signing the Informed Consent Form (ICF), the investigator and study staff will perform a screening evaluation to make sure they are eligible.
Patients who decide to participate in this study will take assigned trial treatment as intended until:
Full details about the study, visits, and examinations will be discussed with the patient before they decide to participate in the study.
If you are interested in learning more about this study, please take the following steps:
Insmed Incorporated, the study sponsor, may cover travel expenses related to your study visits and in applicable countries and only if applicable. Examples of expenses may include:
Additional information on travel support may be provided by the site staff should they decide to participate.
Your patient will need to travel to one of the study clinics taking part in this clinical trial.
Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases.