Clinical Trial: Arikayce for Nontuberculous Mycobacteria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Liposomal Amikacin for Inhalation (Arikayce®) in Patients With Recalcitrant Nontuberculous Mycobacterial Lung Disease
Brief 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 recalcitrant NTM lung disease.
Detailed Summary:
Sponsor: Insmed Incorporated
Current Primary Outcome: Change in semi-quantitative mycobacterial culture results from baseline to end of treatment [ Time Frame: 84 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of subjects with culture conversion to negative [ Time Frame: 84 days ]
- Time to "rescue" anti-mycobacterial drugs [ Time Frame: 84 days ]
- Change from baseline in 6-minute walk distance and oxygen saturation [ Time Frame: 84 days ]
- Change from baseline in Patient Reported Outcomes [ Time Frame: 84 days ]
- Evaluation of safety and tolerability [ Time Frame: For entire study duration ]
Original Secondary Outcome:
- Proportion of subjects with culture conversion to negative [ Time Frame: 84 days ]
- Time to "rescue" anti-mycobacterial drugs [ Time Frame: 84 days ]
- Change from baseline in computed tomography scan abnormalities [ Time Frame: 84 days ]
- Change from baseline in 6-minute walk distance and oxygen saturation [ Time Frame: 84 days ]
- Change from baseline in Patient Reported Outcomes [ Time Frame: 84 days ]
- Evaluation of safety and tolerability [ Time Frame: For entire study duration ]
Information By: Insmed Incorporated
Dates:
Date Received: March 11, 2011
Date Started: May 2012
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016
