Patients in the trial will have lung infections with Mycobacterium avium complex (MAC) or Mycobacterium abscessus, which account for approximately 75 percent to over 85 percent of all patients with NTM lung disease in the U.S.T reatment with A RIKACE to R ealize G reater E fficacy T rial (TARGET-NTM)
- Randomized, placebo-controlled study of ARIKACE in approximately 100 adult patients with recalcitrant NTM lung disease.
- Patients will continue with their antibiotic regimen, and receive additionally, either ARIKACE 560 mg or placebo, delivered once daily via an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH).
- Primary efficacy endpoint will be change in mycobacterial density from baseline to the end of 84 days of treatment, which is the end of the randomized portion of the trial.
- At the conclusion of the randomized portion of the study, eligible patients may receive ARIKACE 560 mg once daily for an additional 84 days in an open-label design. Open-label means the patient will know they are receiving ARIKACE.