Clinical Trial: Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Randomized, Open-label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients With Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (M
Brief Summary: A study to evaluate the effectiveness of Liposomal Amikacin for Inhalation (LAI) when added to multi-drug regimen in subjects with Nontuberculous Mycobacterial (NTM) lung infection caused by Mycobacterium Avium Complex (MAC).
Detailed Summary:
Sponsor: Insmed Incorporated
Current Primary Outcome: Proportion of patients achieving culture conversion in the LAI plus a multi-drug regimen arm compared to a multi-drug regimen alone with no relapse or recurrence [ Time Frame: by 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change from baseline in 6 Minute Walk Test (MWT) distance in the LAI plus a multi-drug regimen compared to a multi-drug regimen alone [ Time Frame: 6 months and up to 16 months ]
Original Secondary Outcome: Same as current
Information By: Insmed Incorporated
Dates:
Date Received: January 9, 2015
Date Started: January 2015
Date Completion: July 2019
Last Updated: February 3, 2017
Last Verified: February 2017
