MedTrace Logo

Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease

NCT03038178 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-04

No results posted yet for this study

Summary

The proposed study will assess the efficacy, safety and tolerability of once daily dosing of Liposomal-Amikacin for Inhalation (LAI) 590 mg for 12 months plus standard of care (SOC) mycobacterial multi-drug regimen in accordance with the 2007 ATS/ IDSA guidelines, for treatment of mycobacterium abscessus lung disease.

Conditions

  • Mycobacterium Infections, Nontuberculous
  • Mycobacteria, Atypical

Interventions

DRUG

LAI plus multi-drug regimen

Liposomal Amikacin for Inhalation (LAI) is the experimental treatment which, in this single arm will be taken in conjunction with standard of care multi-drug treatment regimen

Sponsors & Collaborators

  • Insmed Incorporated

    collaborator INDUSTRY

  • The University of Texas Health Science Center at Tyler

    collaborator OTHER

  • Kevin Winthrop

    lead OTHER

Principal Investigators

  • Kevin L Winthrop, MD, MPH · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03038178 on ClinicalTrials.gov