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 on participant-reported respiratory symptoms at Month 13.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
425
Inhalation via nebulization over approximately 6 to 15 minutes
Oral tablet
Oral tablet
Change from Baseline in Respiratory Symptom Score at Month 13
Time frame: Baseline to Month 13
Percentage of Participants Achieving Durable Culture Conversion at Month 15
Time frame: Month 15
Change from Baseline in Fatigue Symptom Score at Month 13
Time frame: Baseline to Month 13
Percentage of Participants Achieving Culture Conversion by Month 6
Time frame: Month 6
Percentage of Participants Achieving Culture Conversion by Month 12
Time frame: Month 12
Percentage of Participants Achieving Culture Conversion by Month 13
Time frame: Month 13
Percentage of Participants Achieving Culture Conversion During Treatment
Time frame: Baseline to Month 12
Time to Culture Conversion
Time frame: Baseline to Month 12
Time to the First Negative Culture
Time frame: Baseline to Month 12
Percentage of Participants Who Develop a Mycobacterium avium Complex (MAC) Isolate with Amikacin Minimum Inhibitory Concentration (MIC) ≥ 128 μg/mL More Than One Time
Time frame: Baseline to Month 15
Percentage of Participants Achieving Culture Conversion and a Subsequent at Least one MAC Positive Culture in Agar Media or Broth Media in at Least 2 Consecutive Visits With Matching Species and Genome at Screening/ Baseline
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Inhalation via nebulization over approximately 6 to 15 minutes
USA008
Birmingham, Alabama, United States
USA062
Fresno, California, United States
USA060
Los Angeles, California, United States
USA090
Newport Beach, California, United States
USA058
Sacramento, California, United States
USA048
San Diego, California, United States
USA081
San Francisco, California, United States
USA055
Santa Barbara, California, United States
USA050
Stanford, California, United States
USA001
Denver, Colorado, United States
...and 248 more locations
Time frame: Baseline to Month 15
Percentage of Participants Achieving Culture Conversion and a Subsequently have at least One MAC Positive Culture in Agar Media or Broth Media in at Least 2 Consecutive Visits With Differing Species and/or Genome at Screening/ Baseline
Time frame: Baseline to Month 15
Percentage of Participants Meeting the Within-subject Meaningful Change Threshold as Reflected in the Change in Respiratory Symptom Scores Computed From Baseline to Month 13
Time frame: Baseline to Month 13
Number of Participants Who Experience an Adverse Event (AEs)
Time frame: Baseline to Month 15