ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension
Wassim Fares, MD
Abstract
This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)
Randomized, double-blind, placebo-controlled study (Part A) designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT). The primary objective of this study will be to compare the efficacy of Clofazimine Inhalation Suspension versus placebo as assessed by the co-primary endpoints, sputum culture conversion and change in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS).
An open label extension study (Part B) will be offered to qualified participants for treatment with Clofazimine Inhalation Suspension.
MeSH terms
- Mycobacterium Infections, Nontuberculous
- Bronchiectasis
- Mycobacterium avium-intracellulare Infection
- Respiratory Tract Infections
- Mycobacterium Infections
- Infections
- Respiratory Tract Diseases
- Actinomycetales Infections
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Lung Diseases