School of Medicine

Pulmonary/Critical Care

Research

 

Current Trials:

-Nontuberculous Mycobacterium Clinical Database & Biospecimen Bank

-Bronchiectasis Research Registry

-MAC 2v3-Multicenter randomized pragmatic clinical trial comparing two-versus three-antibiotic therapy for pulmonary Mycobacterium avium complex disease

-PARATEK-A Phase 2, double-Blind, Randomized, parallel-Group, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of oral Omadacycline in Adult Subjects with Nontuberculous Mycobacterial (NTM) Pulmonary Disease Caused by Mycobacterium abscessus Complex (MABc)

-EBO-301-A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lund Disease (MACrO2)

-RENOVION-A Phase 2a, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of ARINA-1 administered twice daily by nebulizer in adult participants with non-cystic fibrosis bronchiectasis (NCFBE) with excess mucus and cough

-ASPEN-A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis-

-ENCORE-A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects with newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)

-MAC-CLOFAZIMINE-001 Clofazimine in the treatment of pulmonary Mycobacterium avium complex (MAC) disease

-Post trial Access (PTA) Program for Brensocatib (WILLOW and ASPEN)

-Multiple Patient Program for Lamprene (clofazimine) for the treatment of Non-Tuberculous Mycobacterial (NTM) Infections

 

Completed trials:

-ARISE-A randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lund Infection Caused by Mycobacterium avium Complex (MAC)

-WILLOW- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis

-INS 212-A Randomized, Open-Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (AMC) that are refractory to treatment

-INS 312-An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment