RT Journal Article
SR Electronic
T1 A randomized, open-label, multicenter study of liposomal amikacin for inhalation in adult patients with nontuberculous mycobacteria (NTM) lung infections caused by <em>mycobacterium avium</em> complex (MAC)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA3945
DO 10.1183/13993003.congress-2015.PA3945
VO 46
IS suppl 59
A1 David Griffith
A1 Patrick Flume
A1 Kevin Winthrop
A1 Rachel Thomson
A1 Dirk Wagner
A1 Jakko Van Ingen
A1 Liza Micioni
A1 John P. McGinnis II
A1 Carlos Fernandez
A1 Gina Eagle
YR 2015
UL http://erj.ersjournals.com/content/46/suppl_59/PA3945.abstract
AB Mycobacterium avium: complex (MAC) lung infections are associated with significant morbidity and mortality. Treatment of NTM lung infection is complicated by lengthy multidrug regimens often associated with drug toxicity and suboptimal outcomes. Liposomal amikacin for inhalation (LAI) is a novel inhaled amikacin formulation in development for the treatment of MAC lung infections. In an initial placebo-controlled study of patients with treatment-refractory NTM lung infections, which studied both MAC and M abscessus, (TR02-112), those who had LAI added to their multidrug regimen produced more negative sputum cultures at Day 84 than those on placebo (25.0% vs 6.7%; P=.01).Study INS-212 will evaluate this further by assessing culture conversion (3 consecutive negative sputum cultures) with longer-term LAI treatment added to multidrug regimens.Up to 351 adults ≥18 years with treatment-refractory MAC lung infection (≥2 positive sputum cultures while on a multidrug regimen for ≥6 months) will be stratified by smoking status and multidrug regimen use, and randomized 2:1 to LAI 590 mg QD added to a multidrug regimen or continued on a multidrug regimen alone.The primary endpoint is the proportion of subjects achieving culture conversion by Month 6. Other endpoints include the 6-minute walk test, patient-reported outcomes, and QOL scores.Converters will continue in the study for 12 months from their first negative culture used to define culture conversion. Subjects exiting study for any reason will be contacted for safety follow-up at Month 12.