Article Text
Abstract
600 patients aged ≥18 years will be randomised in a 1:1 ratio to nintedanib or placebo. Patients with diagnosis of IPF will be excluded. The study population will be enriched with two-thirds having a usual interstitial pneumonia-like pattern on HRCT. The primary endpoint is the annual rate of decline in forced vital capacity over 52 weeks. The main secondary endpoints are the absolute change from baseline in King’s Brief Interstitial Lung Disease Questionnaire total score, time to first acute interstitial lung disease exacerbation or death and time to all-cause mortality over 52 weeks.
Ethics and dissemination The trial is conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (GCP) and Japanese GCP regulations.
Trial registration number NCT02999178.
- interstitial fibrosis
- rare lung diseases
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Footnotes
Contributors KRF, KKB, AUW, ECB, HRC, VC, AD, YI, LR, SW and RSH are members of the Trial Steering Committee, responsible for the design of the PF-ILD trial. WM also provided input into the trial design and the content of this manuscript. FLM and HS are the trial statisticians, responsible for the statistical elements of the trial design. All authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. They take full responsibility for the scope, direction, content and editorial decisions relating to the manuscript, were involved in all stages of development and have approved the submitted manuscript.
Funding The PF-ILD trial is funded by Boehringer Ingelheim Pharma GmbH & Co. KG. The authors received no compensation related to the development of the manuscript.
Competing interests KRF reports grants and personal fees from Genentech, grants from Afferent, and personal fees from Boehringer Ingelheim, Veracyte, Roche, Biogen, Aeolus and Pharmakea. KKB reports grants from NHLBI, grants and personal fees from Actelion, Amgen, Gilead, and personal fees from Almiral, Altitude Pharma, Astra Zeneca, Byer, Biogen/Stromedix, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Fibrogen, Galecto, GlaxoSmithKline, MedImmune, Novartis, Pfizer, Promedior, Roche/Genentech, Sanofi/Genzyme, Veracyte, Aeolus and ProMetic. AUW reports lecturing and consultancy fees from Boehringer Ingelheim, Roche, InterMune, Actelion and Bayer. HRC reports personal fees from MedImmune, Bayer, Biogen, Boehringer Ingelheim, Xfibra, Genoa, Gilead, GlaxoSmithKline, Mesoblast, Moerae Matrix, PharmAkea, Promedior, Prometic, Pulmatrix, Pulmonary Fibrosis Foundation (senior medical advisor), Unity, Aeolus, aTyr Pharmaceuticals, Pfizer, UCB Celltech, GBT, Veracyte, Patara, Samumed, Alkermes, Five Prime and Takeda. VC reports personal fees from Actelion, Bayer, Biogen Idec, Boehringer Ingelheim, Gilead, GSK, Intermune, MSD, Novartis, Pfizer, Roche and Sanofi, grants from Actelion, Boehringer Ingelheim, GSK, Pfizer and Roche, and personal fees from Boehringer Ingelheim. YI reports lecture and advisory fees from Boehringer Ingelheim, Shionogi & Co., Ltd., Takeda, Nobel Pharma, Novartis, Serendex, Bayer, Chugai and Daiichi Sankyo. LR reports grants and personal fees from InterMune, and personal fees from MedImmune, Biogen, SanofiAventis, Roche, Takeda, ImmuneWorks, Shionogi, Boehringer Ingelheim and Pliant Therapeutics. ECB, HS, WM and RSH are full-time employees of Boehringer Ingelheim. FLM was a full-time employee of Boehringer Ingelheim at the time of manuscript development. SW and AD report no competing interests.
Ethics approval The trial is conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (GCP) and Japanese GCP regulations.
Provenance and peer review Not commissioned; externally peer reviewed.