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

Study testing inhaled medication for certain lung infections.

Recruiting
18 years and older
All
Phase 3

This study looks at the effects of a treatment called **ALIS** (Amikacin Liposome Inhalation Suspension) for people with a lung infection caused by a type of bacteria called Mycobacterium Avium Complex (MAC). The study will compare the effects of ALIS plus other medicines (azithromycin and ethambutol) with a control group who will get an **empty liposome control** plus the same background medicines. The main goal is to see if ALIS helps improve breathing symptoms after 13 months.

  • This study will last about 13 months.
  • Participants must be 18 years or older, with a confirmed MAC lung infection.
  • Participants cannot have certain conditions like cystic fibrosis or be current smokers.

To join, participants must be willing to follow the study procedures, attend appointments, and provide consent. The study will exclude those with more than 3 past MAC infections or those with certain lung issues. Women and men must agree to use effective birth control during and after the study. Compensation details are not provided, and it is important to consider potential risks and benefits before participating.

Study details
    Mycobacterium Infections
    Nontuberculous

NCT04677569

Insmed Incorporated

13 December 2024

Step 1 Get in touch with the nearest study center
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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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