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Study on the Effects of Amikacin Liposome Inhalation, Azithromycin, and Ethambutol in Adults with Newly Diagnosed Nontuberculous Mycobacterial Lung Infection

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a lung infection known as nontuberculous mycobacterial (NTM) lung infection, specifically caused by a group of bacteria called Mycobacterium avium Complex (MAC). The study is testing a treatment that includes a medication called Amikacin Liposome Inhalation Suspension (ALIS), which is inhaled, along with other medications taken by mouth, such as azithromycin and ethambutol. The purpose of the study is to evaluate how effective this combination of treatments is in improving respiratory symptoms in patients with this type of lung infection.

Participants in the study will receive either the ALIS treatment combined with azithromycin and ethambutol or a placebo, which is a substance with no active medication, combined with azithromycin and ethambutol. The study will last for about 13 months, during which time participants will be monitored for changes in their respiratory symptoms and overall health. The study aims to see if the ALIS-based treatment can help reduce symptoms and improve the quality of life for those with this lung infection.

Throughout the study, participants will have regular check-ups and tests to assess their health and the effectiveness of the treatment. These tests may include providing sputum samples, which are samples of mucus from the lungs, and undergoing imaging tests like computed tomography (CT) scans to look at the lungs. The study will also track any side effects or changes in symptoms to ensure the safety and well-being of the participants.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, the patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and a positive sputum culture for Mycobacterium avium Complex (MAC) within the last six months.

    A chest CT scan may be required if not performed within the last six months to assess lung condition.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with a regimen that includes Amikacin Liposome Inhalation Suspension (ALIS), Azithromycin, and Ethambutol. The ALIS is administered via inhalation, while Azithromycin and Ethambutol are taken orally.

    The specific dosages are as follows: Azithromycin 250 mg film-coated tablets and Ethambutol 100 mg or 400 mg tablets. The frequency and duration of administration will be determined by the study protocol.

  3. Step 3

    Ongoing treatment and monitoring

    Throughout the study, the patient will continue the prescribed treatment regimen. Regular monitoring will occur to assess the effectiveness and safety of the treatment.

    The patient will be required to provide sputum samples periodically to evaluate the presence of MAC and to monitor any changes in respiratory symptoms.

  4. Step 4

    Evaluation at month 13

    At month 13, the primary evaluation will focus on changes in respiratory symptoms compared to the baseline.

    Secondary evaluations will include assessments of fatigue symptoms and the proportion of patients achieving culture conversion, which means having negative cultures for MAC.

  5. Step 5

    Final assessment

    The study will conclude with a final assessment to determine the overall efficacy and safety of the treatment regimen.

    The patient will undergo a comprehensive review of their health status, including any side effects experienced during the study.

Who can join the trial?

14 criteria

  • Must be a male or female who is at least 18 years old. In South Korea, you must be 19 or older, and in Japan, 20 or older.
  • Must currently have a diagnosis of a **MAC lung infection**. This means an infection in the lungs caused by a specific type of bacteria called Mycobacterium avium Complex.
  • Must have a positive **sputum culture** for MAC within 6 months before the screening. A sputum culture is a test to find bacteria in the mucus you cough up from your lungs.
  • Must have a positive sputum culture for MAC at the time of screening.
  • Must have had a **chest CT scan** within 6 months before screening to check for lung cavities. If not, a new chest CT scan will be needed during screening. A CT scan is an imaging test that helps doctors see inside your body.
  • Must have respiratory signs or symptoms at screening that the doctor believes are due to the current MAC lung infection.
  • Must have an average **QOL-B Respiratory domain score** of 85 or less at screening and on the day of enrollment. This score measures the impact of respiratory symptoms on your quality of life.
  • Must have any underlying lung disease, like **COPD** or **bronchiectasis**, managed according to the best local standard of care and be on stable treatment for at least 4 weeks before joining the study. COPD is a lung disease that makes it hard to breathe, and bronchiectasis is a condition where the airways in the lungs are damaged.
  • Must be willing and able to follow the study treatment plan during the study.
  • Must be able to produce about 2 mL of sputum for testing at screening, either naturally or with help.
  • Women who can have children and men who are fertile must agree to use a highly effective method of birth control from the start of the study to at least 90 days after the last dose. Examples include abstinence, copper IUD, hormonal methods, exclusive homosexual relationship, or a male partner who has had a surgical procedure to prevent having children.
  • Must provide signed informed consent before taking any study drugs or undergoing any study-related procedures. This means you agree to participate in the study after understanding all the details.
  • Must be able to follow the study drug use, attend study visits, and complete study procedures as outlined in the study plan.
  • Men with partners who can have children must agree to use condoms, and their partners should use a highly effective method of birth control if not pregnant.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of lung infection that is not caused by Mycobacterium avium Complex (MAC). This is a specific type of bacteria that can cause lung problems.
  • Patients who have already been treated for this specific lung infection before. The study is for those who are newly diagnosed.
  • Patients who are unable to use the inhalation method required for the study. This involves breathing in medication through a special device.
  • Patients with other serious health conditions that might interfere with the study. This could include severe heart, liver, or kidney problems.
  • Patients who are pregnant or breastfeeding. The study may not be safe for unborn babies or infants.
  • Patients who are currently participating in another clinical trial. Being in more than one study at a time can affect the results.
  • Patients who have allergies to the medications used in the study. This includes any known reactions to the drugs being tested.
  • Patients who have a history of substance abuse. This could affect their ability to follow the study procedures.
  • Patients who are unable to provide informed consent. This means they cannot fully understand or agree to the study requirements.
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Investigated drugs

  • Amikacin Liposome Inhalation Suspension (ALIS)

    is a medication used in this trial to treat lung infections caused by a specific type of bacteria known as Mycobacterium avium Complex (MAC). It is administered through inhalation, allowing the medication to directly reach the lungs where the infection is located. This form of amikacin is encapsulated in liposomes, which are tiny fat-like particles that help deliver the drug more effectively to the site of infection.

  • Azithromycin (AZI)

    is an antibiotic that is part of the background regimen in this study. It is used to help fight the bacterial infection in the lungs. Azithromycin works by stopping the growth of bacteria, making it easier for the body to eliminate the infection.

  • Ethambutol (ETH)

    is another antibiotic included in the background regimen. It is used alongside other medications to treat lung infections caused by Mycobacterium avium Complex (MAC). Ethambutol works by inhibiting the growth of bacteria, helping to control and reduce the infection in the lungs.

What is already known about the treatment

Amikacin Liposome Inhalation Suspension (ALIS) – This medication is administered through inhalation, allowing the drug to directly reach the lungs. It is currently being studied in clinical trials for its effectiveness in treating lung infections caused by Mycobacterium avium Complex (MAC) in adults. The main therapeutic use is for nontuberculous mycobacterial lung infections. ALIS works by delivering amikacin, an antibiotic, encapsulated in liposomes, which helps the drug penetrate bacterial cells and inhibit protein synthesis, leading to bacterial death. It is classified as an aminoglycoside antibiotic.

Investigated diseases

Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium avium Complex – This disease is a type of lung infection caused by a group of bacteria known as Mycobacterium avium complex (MAC). It primarily affects individuals with underlying lung conditions or weakened immune systems. The infection leads to symptoms such as chronic cough, fatigue, and weight loss. Over time, it can cause progressive lung damage and respiratory issues. The bacteria are commonly found in the environment, including water and soil, and are inhaled into the lungs. The disease progresses slowly, often requiring long-term management to control symptoms and prevent further lung damage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505273-33-00Protocol codeINS-416Estimated enrolment783 patientsSponsorInsmed Inc.

sourced from the EU Clinical Trials Register and site verification

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