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Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: design of a double-blind, randomised, placebo-controlled phase II trial.

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Title: Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: design of a double-blind, randomised, placebo-controlled phase II trial.
Authors: Maher, TM
Corte, TJ
Fischer, A
Kreuter, M
Lederer, DJ
Molina-Molina, M
Axmann, J
Kirchgaessler, K-U
Cottin, V
Item Type: Journal Article
Abstract: Introduction: Despite extensive multidisciplinary team (MDT) assessment, some patients have interstitial lung disease (ILD) that is considered unclassifiable (uILD), for which there are currently no approved treatments. This study will assess the efficacy and safety of the antifibrotic pirfenidone in treating uILD. Methods and analysis: This double-blind, randomised, placebo-controlled phase II trial is enrolling adults with fibrosing ILD, including uILD that fulfils proposed research criteria for interstitial pneumonia with autoimmune features (IPAF), that cannot be classified with moderate or high confidence to any category of ILD following MDT discussion. Study participants must have >10% fibrosis on high-resolution CT scan within the previous 12 months, forced vital capacity (FVC) ≥45% and diffusing capacity of the lung for carbon monoxide ≥30% of predicted values. Study participants will be randomised to receive 801 mg pirfenidone or placebo three times daily for 24 weeks. The efficacy of pirfenidone vs placebo will be assessed by daily measurement of FVC using a handheld spirometer over the treatment period. Other functional parameters, patient-reported outcomes, samples for biomarker analysis and safety endpoints will be collected. Additionally, the study will assess the efficacy and safety of pirfenidone with and without concomitant mycophenolate mofetil treatment and in study participants with or without IPAF. Ethics and dissemination: This trial is being conducted in accordance with the International Conference on Harmonisation E6 guideline for Good Clinical Practice, Declaration of Helsinki and local laws for countries in which the research is conducted. Trial registration number: NCT03099187.
Issue Date: 4-Sep-2018
Date of Acceptance: 13-Jul-2018
URI: http://hdl.handle.net/10044/1/62755
DOI: https://dx.doi.org/10.1136/bmjresp-2018-000289
ISSN: 2052-4439
Publisher: BMJ Publishing Group
Journal / Book Title: BMJ Open Respiratory Research
Volume: 5
Issue: 1
Copyright Statement: © 2018 Author(s) (or their employer(s)). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0
Keywords: antifibrotic
interstitial pneumonia with autoimmune features
pirfenidone
unclassifiable interstitial lung disease
Publication Status: Published
Conference Place: England
Online Publication Date: 2018-09-04
Appears in Collections:National Heart and Lung Institute
Faculty of Medicine



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