Nintedanib in children and adolescents with fibrosing interstitial lung diseases.

ABSTRACT:

Background

Childhood interstitial lung disease (ILD) comprises a spectrum of rare ILDs affecting infants, children and adolescents. Nintedanib is a licensed treatment for pulmonary fibrosis in adults. The primary objectives of the InPedILD trial were to determine the dose-exposure and safety of nintedanib in children and adolescents with fibrosing ILD.

Methods

Patients aged 6-17 years with fibrosing ILD on high-resolution computed tomography and clinically significant disease were randomised 2:1 to receive nintedanib or placebo for 24 weeks and then open-label nintedanib. Dosing was based on weight-dependent allometric scaling. Co-primary end-points were the area under the plasma concentration-time curve at steady state (AUC_τ,ss) at weeks 2 and 26 and the proporti

SUBMITTER: Deterding R 

PROVIDER: S-EPMC9892863 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature