Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex — ENCORE

Mycobacterium Infections, Nontuberculous Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobact

Status Recruiting

Clinical Trial Summary

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Infections
Mycobacterium Infections
Mycobacterium Infections, Nontuberculous

Clinical Trial Details

NCT number	NCT04677569
Study type	Interventional
Source	Insmed Incorporated
Contact	Insmed Medical Information
Phone	844-4-INSMED
Email	medicalinformation@insmed.com
Status	Recruiting
Phase	Phase 3
Start date	April 1, 2021
Completion date	August 21, 2023

View Details

See also
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