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

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.

Timeline

Start

2016-10

Primary completion

2019-10-31

Completion

2019-12-31

Publications

• Siegel SAR, Griffith DE, Philley JV, Brown-Elliott BA, Brunton AE, Sullivan PE, Fuss C, Strnad L, Wallace RJ Jr, Winthrop KL. Open-Label Trial of Amikacin Liposome Inhalation Suspension in Mycobacterium abscessus Lung Disease. Chest. 2023 Oct;164(4):846-859. doi: 10.1016/j.chest.2023.05.036. Epub 2023 Jun 17.

Drugs

Indications