Mycobacterium Infections, Nontuberculous Clinical Trial
Official title:
A Randomized, Open-label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC) That Are Refractory to Treatment
A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) 590 mg
administered once daily (QD) when added to multi-drug regimen (MDR) in participants with
Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC)
that were refractory to treatment.
Participants were randomized 2:1 to LAI 590 mg administered QD + MDR or MDR alone.
This is a randomized, open-label, multicenter study of LAI in adult participants with NTM
lung infections caused by MAC that were refractory to treatment. Participants received either
LAI 590 mg administered QD by inhalation plus a multidrug regimen, hereafter referred to as
LAI + MDR or a multidrug regimen alone, hereafter referred to as MDR alone for a minimum of 8
months. Participants who demonstrated culture conversion by Month 6 went on to complete a
treatment course of 12 months, starting from the first of 3 negative cultures that defined
culture conversion.
Sputum culture results were made available to the site after the Month 6 sputum result was
known, in time for the Month 8 visit. Prior to the Month 8 visit, the culture results from
Baseline to Month 6 inclusively were blinded to the site and Sponsor. The results were
blinded to reduce the potential for bias in an open-label study. At Month 8 (-28 to +7 days),
after all sputum culture results were made available to the site only, up to and including
Month 6, participants were assessed as converters or non-converters.
A converter was defined as a participant who had 3 consecutive monthly MAC-negative sputum
cultures at any time within the first 6 months of the study.
"Relapse or recurrence" was defined as having MAC-positive sputum cultures in liquid broth
media (agar negative) for 3 or more consecutive months, or having at least 1 MAC-positive
sputum culture on solid media (agar positive) after achieving culture conversion.
A non-converter was defined as a participant who did not have 3 consecutive monthly
MAC-negative sputum cultures at any time within the first 6 months of the study.
All converters remained in the study. Converters who, after culture conversion, subsequently
had MAC-positive sputum cultures in liquid broth media (agar negative) for 1 or 2 consecutive
months only by Month 6 also remained in the study. Participants who remained in the study
continued their randomized treatment regimen until they completed a total of 12 months of
treatment (EOT), starting from the first of 3 negative cultures that defined culture
conversion. These participants returned after the EOT visit for 28 days, 3, 6, and 12 months
off-treatment follow-up visits. The 12 months off-treatment follow-up visit was the end of
study (EOS) visit. No NTM treatment was administered during the off-treatment phase.
At Month 8, all non-converters as assessed at the Month 6 visit were discontinued from Study
INS-212. Participants who experienced a relapse or recurrence by Month 6 also discontinued
from Study INS-212 at their Month 8 visit. These participants were potentially eligible to
enter a separate open-label study of LAI (Study INS-312), provided all entry criteria were
met for that study.
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