CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 163 enrolled
Drug / intervention
LAI 590 mg +1 moredrug
Likely dose
LAI 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/NCT02628600
NCT02628600Phase 3Completed
CompareCT.gov

An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infections Caused by Mycobacterium Avium Complex (MAC) That Are Refractory to Treatment

Insmed Incorporated·interventional·Posted Dec 11, 2015·Updated Feb 10, 2020

In Brief

A Phase 3 clinical trial evaluating LAI 590 mg and Multi-drug regimen for NTM Lung Infection Due to MAC. Completed, enrolled 163 participants.

Detailed Summary

This is an open-label safety extension study to assess the safety and tolerability of once daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212 (NCT02344004).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNTM Lung Infection Due to MAC
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 11, 2015
Enrollment StartFeb 5, 2016
Primary CompletionOct 17, 2018
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.6 years ago

Interventions

LAI 590 mgdrug

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

Multi-drug regimendrug

Multidrug antimycobacterial regimen from study INS-212