Olivier 2016.

Methods	Randomized (1:1), double‐blind, placebo‐controlled trial. Participants to visit the clinic approximately every 28 days for efficacy, safety and tolerability evaluations.
Participants	Adults (both with CF and without CF) with recalcitrant non‐tuberculous mycobacterial lung disease on a stable multi‐drug regimen. Eligible age range 18 to 75 years. Estimated number to recruit: 100.
Interventions	Liposomal amikacin (Arikace®, 560 mg) for inhalation once daily using the PARI Investigational eFlow® Nebulizer (administration time approximately 13 minutes) or placebo (administration procedures, volume and administration time is the same as for Arikace®). Randomized treatment period planned for 84 days (Arikace® and placebo) with an option for 84 additional days of dosing with Arikace® in the open‐label extension.
Outcomes	Primary outcome Change in semi‐quantitative mycobacterial culture results from baseline to end of treatment Secondary outcomes Proportion of participants with culture conversion to negative Time to 'rescue' anti‐mycobacterial drugs Change from baseline in 6‐minute walk distance and oxygen saturation Change from baseline in patient‐reported outcomes Evaluation of safety and tolerability
Notes	Principle investigator confirmed inclusion of participants with CF. Supported by Insmed Incorporated.

CF: cystic fibrosis