At a glance
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A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease
In Brief
A Phase 2 clinical trial evaluating Liposomal amikacin for inhalation (LAI) and placebo for Mycobacterium Infections, Nontuberculous. Completed, enrolled 90 participants across 19 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
* 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.
* 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.