CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 336 enrolled
Drug / intervention
LAI (Liposomal Amikacin for Inhalation) 590 mgdrug
Likely dose
LAI (Liposomal Amikacin for Inhalation) 590 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02344004
NCT02344004Phase 3Completed
CompareCT.gov

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

Insmed Incorporated·interventional·Posted Jan 22, 2015·Updated May 7, 2020

In Brief

A Phase 3 clinical trial evaluating LAI (Liposomal Amikacin for Inhalation) 590 mg for Mycobacterium Infections, Nontuberculous. Completed, enrolled 336 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMycobacterium Infections, Nontuberculous
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 22, 2015
Enrollment StartMay 27, 2015
Primary CompletionJul 3, 2018
Study CompletionApr 3, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.4 years ago

Interventions

LAI (Liposomal Amikacin for Inhalation) 590 mgdrug

LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes.