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Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Evaluating ALIS for lung infection from Mycobacterium Avium Complex.

Recruiting
18 years and older
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is looking at how well a medicine called ALIS (Amikacin Liposome Inhalation Suspension) works for people with a type of lung infection caused by germs known as Mycobacterium Avium Complex (MAC). ALIS is a medicine you breathe in. It will be given with other regular medicines like azithromycin (AZI) and ethambutol (ETH). The study will last for 13 months, and they want to see how well people feel and breathe during this time. Some people in the study will not get ALIS; instead, they'll get a harmless liquid called ELC (Empty Liposome Control) with the regular medicines to compare results.

  • Participants need to be at least 18 years old and have a current MAC lung infection.
  • You must be willing to follow the study's rules and visit the study site for check-ups.
  • People with certain health issues, like cystic fibrosis or recent smoking history, cannot join.

Before joining, you must agree to use birth control and not have certain health conditions. If you meet these requirements and join, you will help doctors learn more about this treatment.

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Study details
    Mycobacterium Infections
    Nontuberculous

NCT04677569

Insmed Incorporated

13 December 2024

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