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Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria

NCT01315236 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-08-21

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of 84 days of daily dosing of 590 mg of LAI versus placebo in patients with treatment refractory NTM lung disease.

The first part of the study is the 84-day double-blind phase to evaluate the primary and secondary endpoints.

Conditions

  • Mycobacterium Infections, Nontuberculous

Interventions

DRUG

Liposomal amikacin for inhalation (LAI)

* Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization. * 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer. * Administration time is approximately 13 minutes. * Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study. * Subjects can continue with 84 additional days of dosing in the open label extension.

DRUG

placebo

* Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization. * Administration procedures, volume and administration time are similar to LAI. * Placebo will be administered for 84 days only during the double-blind, randomized portion of the study.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Insmed Incorporated

    lead INDUSTRY

Principal Investigators

  • Gina Eagle · Insmed Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-19
Primary Completion
2014-08-18
Completion
2015-06-18

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
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 NCT01315236 on ClinicalTrials.gov