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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B)
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U25-153-1
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A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B)
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Dr. David Fraulino
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MannKind is developing an inhaled suspension of clofazimine, MNKD-101 (hereafter referred to as Clofazimine Inhalation Suspension), to be delivered directly to the site of infection in the lungs via a jet nebulizer. Efficacy data from relevant nonclinical models support the evaluation of Clofazimine Inhalation Suspension for the treatment of pulmonary NTM infection. The primary objective of Part A will be to compare the efficacy of Clofazimine Inhalation Suspension versus placebo when added to GBT as assessed by the co-primary endpoints, sputum culture conversion and change in Quality of Life-Bronchiectasis Respiratory Symptoms Score (QoL-B RSS).
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Bacterial and Fungal
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Breathing and Lung
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Check with study contact
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Nicole Glidden. Telephone: 860-679-8511 or 860-679-4647. Email: DOMClinicalResearch@uchc.edu
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Enrolling/recruiting. For current recruitment status, please check with study contact.
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