Imperial College London
Alternate

Professor Toby Maher

Faculty of Medicine, National Heart & Lung Institute

Professor of Interstitial Lung Disease
 
 
 
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Contact

 

+44 (0)20 7594 2151t.maher

 
 
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Assistant

 

Ms Georgina Moss +44 (0)20 7594 2151

 
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Location

 

364Sir Alexander Fleming BuildingSouth Kensington Campus

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Summary

 

Publications

Citation

BibTex format

@article{Maher:2020:10.1016/S2213-2600(19)30341-8,
author = {Maher, TM and Corte, TJ and Fischer, A and Kreuter, M and Lederer, DJ and Molina-Molina, M and Axmann, J and Kirchgaessler, K-U and Samara, K and Gilberg, F and Cottin, V},
doi = {10.1016/S2213-2600(19)30341-8},
journal = {The Lancet Respiratory Medicine},
pages = {147--157},
title = {Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial},
url = {http://dx.doi.org/10.1016/S2213-2600(19)30341-8},
volume = {8},
year = {2020}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: At present, no approved pharmacotherapies are available for unclassifiable interstitial lung disease (ILD), which is characterised by progressive fibrosis of the lung. We aimed to assess the efficacy and safety of pirfenidone in patients with progressive fibrosing unclassifiable ILD. METHODS: We did a multicentre, double-blind, randomised, placebo-controlled phase 2 trial at 70 centres in Australia, Belgium, Canada, Czech Republic, Denmark, Germany, Greece, Ireland, Israel, Italy, Poland, Portugal, Spain, and the UK. Eligible patients (aged ≥18-85 years) had progressive fibrosing unclassifiable ILD, a percent predicted forced vital capacity (FVC) of 45% or higher and percent predicted carbon monoxide diffusing capacity (DLco) of 30% or higher, more than 10% fibrosis on high-resolution CT, and a high-resolution CT from the previous 12 months. Patients were randomly assigned (1:1) to 2403 mg oral pirfenidone daily or placebo using a central validated interactive voice or web-based response system, stratified by concomitant mycophenolate mofetil use and presence or absence of interstitial pneumonia with autoimmune features. Investigators, site personnel, and patients were masked to treatment assignment. The primary endpoint was mean predicted change in FVC from baseline over 24 weeks, measured by daily home spirometry. Secondary endpoints were change in FVC measured by site spirometry, proportion of patients who had a more than 5% or more than 10% absolute or relative decline in percent predicted FVC measured by clinic-based spirometry, change in percent predicted DLco, change in 6-min walk distance (6MWD), change in University of California San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) score, change in Leicester Cough Questionnaire score, change in cough visual analogue scale, and changes in total and subscores of the St George's Respiratory Questionnaire (SGRQ), all of which were compared with baseline. Additional secondary endpoints included
AU  - Maher,TM
AU  - Corte,TJ
AU  - Fischer,A
AU  - Kreuter,M
AU  - Lederer,DJ
AU  - Molina-Molina,M
AU  - Axmann,J
AU  - Kirchgaessler,K-U
AU  - Samara,K
AU  - Gilberg,F
AU  - Cottin,V
DO  - 10.1016/S2213-2600(19)30341-8
EP  - 157
PY  - 2020///
SN  - 2213-2600
SP  - 147
TI  - Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial
T2  - The Lancet Respiratory Medicine
UR  - http://dx.doi.org/10.1016/S2213-2600(19)30341-8
UR  - https://www.ncbi.nlm.nih.gov/pubmed/31578169
UR  - https://www.sciencedirect.com/science/article/pii/S2213260019303418?via%3Dihub
UR  - http://hdl.handle.net/10044/1/74066
VL  - 8
ER  -
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