1199-0378 InPedILD™-ON

  • Research type

    Research Study

  • Full title

    An open-label trial of the long-term safety and tolerability of nintedanib per os, on top of standard of care, over at least 2 years, in children and adolescents with clinically significant fibrosing Interstitial Lung Disease (InPedILD™-ON)

  • IRAS ID

    302533

  • Contact name

    Steve Cunningham

  • Contact email

    Steve.Cunningham@ed.ac.uk

  • Sponsor organisation

    Boehringer Ingelheim Ltd

  • Eudract number

    2020-005554-23

  • Clinicaltrials.gov Identifier

    NCT05285982

  • Duration of Study in the UK

    4 years, 1 months, 26 days

  • Research summary

    Childhood interstitial lung disease ‘ILD’ syndrome is a term used to describe lung disease in children with non-specific respiratory symptoms. It includes a group of respiratory diseases that are associated with chronic fibrosis (scarring of the lung tissue). There are no currently approved therapies for the treatment of ILD in children. Nintedanib is a study drug that aims to reduce fibrosis in the lungs. It is currently being used in a trial to test the safety of nintedanib in children (the InPedILD™ study). The aim of this current study is to test the long-term safety of nintedanib in children with fibrosing ILD, for at least 2 years. Children and adolescents with clinically significant fibrosing ILD will be invited to take part in this trial, including those who have completed the InPedILD™ study.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    21/LO/0814

  • Date of REC Opinion

    10 Jan 2022

  • REC opinion

    Further Information Favourable Opinion