ENCORE - A Randomized Double-Blind Placebo-Controlled Active Comparator Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Mycobacterium Avium Complex
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Current diagnosis of MAC lung infection
    2. Positive sputum culture for MAC within 6 months prior to Screening
    3. Positive sputum culture for MAC at Screening
    4. A high-resolution chest computed tomography (CT) scan or chest CT scan with contrast
    5. In the Investigator’s opinion, documented respiratory signs/symptoms at Screening that are attributable to the current MAC lung infection
    6. Women of child bearing potential (WOCBP) agrees to practice an acceptable method of birth control while participating in the study
    7. Participants provides written informed consent
    8. Ability to comply with study drug use, study visits, and study procedures as defined by the protocol
    9. Ability to produce (spontaneously or with induction) approximately 2 mL of sputum for mycobacteriology at Screening

You may not be eligible for this study if the following are true:

    1. Diagnosis of cystic fibrosis (CF)
    2. History of 3 or more prior MAC lung infections
    3. Received any mycobacterial antibiotic treatment for current MAC lung infection
    4. Refractory MAC lung infection
    5. Relapse of prior MAC lung infection
    6. Evidence of any pulmonary cavity = 2 cm in diameter
    7. Radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening
    8. Active pulmonary malignancy or any malignancy requiring chemotherapy or radiation therapy
    9. Prior exposure to ALIS



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