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Nintedanib in patients with chronic fibrosing interstitial lung diseases with progressive phenotype: the INBUILD trial

Kevin R. Flaherty, Athol U. Wells, Vincent Cottin, Anand Devaraj, Yoshikazu Inoue, Luca Richeldi, Simon Walsh, Susanne Stowasser, Carl Coeck, Rainer-Georg Goeldner, Emmanuelle Clerisme-Beaty, Rozsa Schlenker-Herceg, Kevin K. Brown
European Respiratory Journal 2019 54: RCT1881; DOI: 10.1183/13993003.congress-2019.RCT1881
Kevin R. Flaherty
1Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, United States of America
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  • For correspondence: flaherty@umich.edu
Athol U. Wells
2National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London, United Kingdom
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Vincent Cottin
3Respiratory Diseases Department, National Reference Center for Rare Pulmonary Diseases, Respiratory Diseases Department, Louis Pradel Hospital, Claude Bernard Lyon 1 University, Lyon, France
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Anand Devaraj
4Department of Radiology, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom
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Yoshikazu Inoue
5Clinical Research Center, National Hospital Organization, Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan
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Luca Richeldi
6Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
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Simon Walsh
7National Heart and Lung Institute, Imperial College, London, United Kingdom
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Susanne Stowasser
8Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
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Carl Coeck
9SCS Boehringer Ingelheim Comm.V., Brussels, Belgium
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Rainer-Georg Goeldner
10Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany
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Emmanuelle Clerisme-Beaty
8Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
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Rozsa Schlenker-Herceg
11Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, United States of America
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Kevin K. Brown
12Department of Medicine, National Jewish Health, Denver, CO, United States of America
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Abstract

Introduction: Nintedanib is an approved treatment for idiopathic pulmonary fibrosis (IPF). Pre-clinical data suggest that nintedanib inhibits processes fundamental to progression of lung fibrosis irrespective of the aetiology.

Aim: The INBUILD trial was designed to investigate the efficacy and safety of nintedanib in patients with various non-IPF chronic fibrosing ILDs with progressive phenotype.

Methods: Eligible patients had diffuse fibrosing lung disease of >10% extent on HRCT, FVC ≥45% predicted, DLco ≥30–<80% predicted, and met ≥1 of 4 criteria for ILD progression (Table) in the 24 months before screening, despite treatment of ILDs in clinical practice. Patients with IPF were excluded. Subjects were randomised to receive nintedanib 150 mg bid or placebo. The primary endpoint is the annual rate of decline in FVC (mL/yr) assessed over 52 weeks. There will be two co-primary analysis populations: all subjects and subjects with a UIP-like fibrotic pattern only on HRCT.

Results: 663 patients were randomised and treated (Table). Mean (±SD) age was 65.8±9.8 years, FVC was 69.0±15.7% predicted, DLco was 47.6±32.2% predicted.

Conclusions: The INBUILD trial will provide insights into the natural history and role of nintedanib in treating patients with various progressive fibrosing ILDs. Results will be presented at the congress.

  • Orphan diseases
  • Treatments
  • RCT (Randomized Controlled Trial)

Footnotes

Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, RCT1881.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

  • Copyright ©the authors 2019
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Nintedanib in patients with chronic fibrosing interstitial lung diseases with progressive phenotype: the INBUILD trial
Kevin R. Flaherty, Athol U. Wells, Vincent Cottin, Anand Devaraj, Yoshikazu Inoue, Luca Richeldi, Simon Walsh, Susanne Stowasser, Carl Coeck, Rainer-Georg Goeldner, Emmanuelle Clerisme-Beaty, Rozsa Schlenker-Herceg, Kevin K. Brown
European Respiratory Journal Sep 2019, 54 (suppl 63) RCT1881; DOI: 10.1183/13993003.congress-2019.RCT1881

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Nintedanib in patients with chronic fibrosing interstitial lung diseases with progressive phenotype: the INBUILD trial
Kevin R. Flaherty, Athol U. Wells, Vincent Cottin, Anand Devaraj, Yoshikazu Inoue, Luca Richeldi, Simon Walsh, Susanne Stowasser, Carl Coeck, Rainer-Georg Goeldner, Emmanuelle Clerisme-Beaty, Rozsa Schlenker-Herceg, Kevin K. Brown
European Respiratory Journal Sep 2019, 54 (suppl 63) RCT1881; DOI: 10.1183/13993003.congress-2019.RCT1881
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