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Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212

NCT02628600 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2020-02-10

Study results available
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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).

Conditions

  • NTM Lung Infection Due to MAC

Interventions

DRUG

LAI 590 mg

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

DRUG

Multi-drug regimen

Multidrug antimycobacterial regimen from study INS-212

Sponsors & Collaborators

Principal Investigators

  • Kevin Mange, MD · Insmed Incorporated

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-05
Primary Completion
2018-10-17
Completion
2018-10-17

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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 NCT02628600 on ClinicalTrials.gov