This site uses cookies. By continuing to browse the site you are agreeing to our use of cookies.

Nintedanib and placebo in patients with PF-ILD.

  • Research type

    Research Study

  • Full title

    A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD).

  • IRAS ID

    217658

  • Contact name

    Jill Dincki

  • Contact email

    jill.dincki@boehringer-ingelheim.com

  • Sponsor organisation

    Boehringer-Ingelheim

  • Eudract number

    2015-003360-37

  • Clinicaltrials.gov Identifier

    NCT02999178

  • Duration of Study in the UK

    2 years, 8 months, 7 days

  • Research summary

    This is a double blind, randomised, placebo-controlled trial evaluating the efficacy and safety of nintedanib over 52 weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD). Patients will be assigned by random selection to receive either the investigational drug nintedanib 150mg two times daily or placebo two times daily. The duration of the treatment phase for patients will be at least 52 weeks. Approximately 25 people will participate in this study in the United Kingdom and approximately 600 participants worldwide. The primary objective is to demonstrate a reduction in lung function decline, as measured by the annual rate of decline in Forced Vital Capacity (FVC) for nintedanib compared to placebo over 52 weeks.

  • REC name

    East Midlands - Leicester Central Research Ethics Committee

  • REC reference

    17/EM/0044

  • Date of REC Opinion

    3 Mar 2017

  • REC opinion

    Further Information Favourable Opinion