-
ICoN-1 Phase 3 Study Of The Efficacy And Safety Of Treatment With MNKD-101, Clofazimine Inhalation Suspension
Rochester, MN
The purpsoe of this study is to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
Mayo Clinic will not be participating in the optional PK sub-study.
-
An Extension Study Assessing The Long-Term Safety, Tolerability, And Effectiveness Of Liposomal Amikacin Inhalant In Patients With Non-Tuberculous Mycobacterial Lung Infections, Who Participated In Study INS-212
Rochester, MN
The purpose of this extension study is to assess the safety, tolerability, and effectiveness of Liposomal Amikacin for Inhalation added to a multi-drug regimen in subjects with non-tuberculous mycobacterium lung infections due to Mycobacterium avium complex who were resistant to therapy in Study INS-212.
-
A Study To Evaluate Lamprene (Clofazimine) To Treat Non-Tuberculous Mycobacterial (NTM) Infections
Jacksonville, FL
The purpose of this study is to evaluate Lamprene (Clofazimine) to treat non-tuberculous mycobacterial (NTM) infections.
-
ORC-13661 For The Prevention Of Drug-Induced Hearing Loss In Intravenous Amikacin Treatment Of Non-Tuberculous Mycobacterium Disease
Rochester, MN
The purpoes of this study is to evaluate the safety of ORC-13661 and its ability to significantly mitigate or prevent hearing loss in patients being treated with intravenous (IV) amikacin.
-
Study To Evaluate Efficacy Of LAI When Added To Multi-drug Regimen Compared To Multi-drug Regimen Alone
Rochester, MN
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).
-
A Study To Compare Two Vs. Three Antibiotic Therapies For Pulmonary Mycobacterium Avium Complex Disease
Rochester, MN
The purpose of this study is to determine whether 2-drug therapy is non-inferior to 3-drug therapy against pulmonary mycobacterium avium complex (MAC) disease, and whether 2-drug therapy is better tolerated than 3-drug therapy.
-
A Study To Evaluate The Effectiveness And Safety Of An Amikacin Liposome Inhalation Suspension-based Regimen In Adults With Nontuberculous Mycobacterial Lung Infection
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the effectiveness of ALIS + azithromycin (AZI) + ethambutol (ETH) compared to the empty liposome control (ELC) + AZI + ETH on patient reported respiratory symptoms at Month 13.
-
A Study Of Inhaled Molgramostim In Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection
Rochester, MN
The purpose of this study is to evaluate the effectiveness of inhaled molgramostim, administered open-label, to adult cystic fibrosis subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing antimycobacterial guideline based combination therapy.