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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
Nintedanib DPI is a dry powder nintedanib formulation for oral inhalation.
Placebo oral inhalation powder
Trial Management Group Inc
Windsor, Ontario, Canada
RECRUITINGSafety and Efficacy
Safety and tolerability of different doses and to confirm an optimal dose of Nintedanib Dry Powder Inhalation (DPI)
Time frame: From enrollment to the end of randomized treatment at 12 weeks
Events of clinical bronchospasm
Events of clinical bronchospasm (e.g., treatment-emergent adverse event \[TEAE\] of wheezing or chest tightness immediately after inhalation)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
FEV1 change
Change in forced expiratory volume in 1 second (FEV1) (mL)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Spirometry Change
Change in FEV1/forced vital capacity (FVC) ratio
Time frame: enrollment to end of open label at 36 weeks
Study Drug Discontinuation
Rate of study drug discontinuations
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Study Drug Dose Reductions
Rate of study drug dose reductions
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Adverse Events
Rate of TEAEs
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Related Adverse Events
Rate of treatment-related adverse events (TRAEs)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Serious Adverse Events
Rate of serious adverse events (SAEs)
Time frame: From enrollment to the end of open-label treatment at 36 weeks
Efficacy of Nintedanib DPI
To assess a potential efficacy signal of different doses of Nintedanib DPI over 12 weeks in patients with IPF.
Time frame: From enrollment to the end of randomized treatment at 12 weeks
Wassim Fares, MD, SVP, Therapeutic Area Head, Orphan Lung Disease, MD
CONTACT
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