Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Sponsor: Mannkind Corporation • ClinicalTrials.gov ID: NCT07679893
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This trial is a randomized, double-blind, placebo-controlled study evaluating the safety and preliminary efficacy of inhaled Nintedanib Dry Powder Inhalation (DPI) in adults with idiopathic pulmonary fibrosis (IPF). Participants are randomized to receive either 2 mg BID, 4 mg BID, or matching placebo for 12 weeks, followed by a 24-week open-label extension in which all participants receive active treatment. The primary focus is on safety-particularly bronchospasm events, lung function changes (FEV1, FEV1/FVC), and adverse event rates and assessing the effectiveness of nintedanib DPI in treating IPF.
Interventions
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Nintedanib Dry Powder Inhalation
(Drug)
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
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Placebo
(Drug)
Placebo oral inhalation powder
Eligibility criteria
Conditions
Locations
- Trial Management Group Inc — Windsor, Ontario, Canada
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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