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Authors
Podolanczuk, Anna J. http://orcid.org/0000-0002-9559-1485
Kim, John S. http://orcid.org/0000-0002-8887-150X
Cooper, Christopher B. http://orcid.org/0000-0002-6314-0903
Lasky, Joseph A.
Murray, Susan
Oldham, Justin M. http://orcid.org/0000-0003-4957-8869
Raghu, Ganesh http://orcid.org/0000-0001-7506-6643
Flaherty, Kevin R. http://orcid.org/0000-0001-7686-0291
Spino, Cathie http://orcid.org/0000-0002-6157-6738
Noth, Imre http://orcid.org/0000-0001-9846-5030
Martinez, Fernando J. http://orcid.org/0000-0002-2412-3182
,
Freiheit, Elizabeth
Martin-Schwarze, Adam
Szparza, Ashley
Naik, Tanvi
Edwards, Rex
Bernard, Gordon
Barnbaum, Deborah
de Andrade, Joao
Knoell, Daren
Lindenauer, Peter
Rogatko, Andre
Temprosa, Marinella
Ma, Shwu-Fan
Strickland, Emma
Sheth, Jamie
Lee, Joyce
Nickerson-Nutter, Cheryl
Lebo, David
Belloli, Elizabeth
Flaherty, Candace
Whelan, Timothy
Lento, Max
Case, Amy
Nwosu, Ugonna
Kottmann, Matthew
Criner, Gerard
Juhas, Julie
Mooney, Joshua
Smith, Jeanette
Limper, Andrew
Daley, Shannon
Paul, Tessy
Althulth, Yousef
Newton, Chad
Gordon, Rhoda Annoh
Strek, Mary
Maleckar, Spring
Kim, Hyun
DeGrote, Mandi
Blissell, Reba
Kaner, Robert
Peters, Elizabeth
Morris, Alicia
Hamblin, Mark
Ward, Carime
Boente, Ryan
Willig, Meghan
Bhatt, Nitin
Hood, Benjamin
Wilson, Cathleen
Chaudhary, Sachin
Erickson, Heidi
Lengel, Haylie
Dilling, Daniel
Montesi, Sydney
Fromson, Caroline
Maher, Toby
Nambiar, Anoop
Pomroy, Hilda
Scholand, Mary Beth
Kirkpatrick, Chloe
Lancaster, Lisa
Del Greco, Jim
Weigt, Stephen Sam
Callahan, Eileen
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Clinical Trials BETA
Clinical trials referenced in this document:
nct04300920 at ClinicalTrials.govDocuments that mention this clinical trial
Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial
https://doi.org/10.1186/s12890-022-02281-8
Advances in the management of idiopathic pulmonary fibrosis and progressive pulmonary fibrosis
https://doi.org/10.1136/bmj-2021-066354
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Funding
Funding for this research was provided by:
National Heart, Lung, and Blood Institute (UH3HL145266, U24 HL145265)
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Article History
Received: 1 September 2022
Accepted: 8 December 2022
First Online: 13 December 2022
Declarations
:
: The protocol was reviewed and approved by an independent DSMB. All participating sites used a single Institutional Review Board (sIRB) to conduct the ethical review, in accordance with NIH policy. The Biomedical Research Alliance of New York (BRANY) was the sIRB for this study (Protocol # 19-02-406). BRANY approved the study. All participants will sign an inform consent to participate in the clinical trial.
: Not applicable.
: Dr. Podolanczuk grants from NIH (NHLBI K23HL140199), grants from American Lung Association, consulting fees from Regeneron, Roche, Imvaria, Boehring Ingelheim, and personal fees from National Association for Continuing Medical Education and EBSCO/DynaMed. Dr. Kim reports grants from NIH (NHLBI K23 award 150301) during the conduct of the study; he also reports grant funding from the Pulmonary Fibrosis Foundation outside the submitted work, and servin on a data and safety monitoring board (unpaid) for convalescent plasma trial for COVID-19. Dr. Cooper reports grants from NIH/NHLBI, Foundation NIH and the COPD Foundation, during the conduct of the study; he also reports personal fees from PulmonX, GlaxoSmithKline, Chiesi, NUVAIRA, MGC Diagnostics and Horizon Therapeutics, outside the submitted work. Dr. Lasky reports grants from Boehringer Ingelheim, personal fees from Boehringer Ingelheim, Veracyte, United Therapeutics, participation on an advisory board for Galecto, and a leadership role in the Pulmonary Fibrosis Foundation. Dr. Murray reports grant funding from the NIH (U24 HL145265) during the conduct of the study. Dr. Oldham reports grants from National Institutes of Health and an issued patent related to this work, along with personal fees from Boehringer Ingelheim, Roche/Genentech, AmMax Bio, Lupin pharmaceuticals and Endeavor BioMedicines unrelated to this work. Dr. Raghu reports receiving research grants from the National Institutes of Health for this trial. Dr Raghu reports receiving fees for serving as an ad hoc discussant from Bristol Myers Squibb and United Therapeutics, receiving consulting fees from Veracyte, receiving fees for reviewing investigator initiated research grant proposals from Boehringer Ingelheim, providing unpaid consulting services for Biogen, Bellerophon Therapeutics, Blade Therapeutics, FibroGen, Nitto, Roche/Genentech, and Novartis, serving (unpaid) on a data and safety monitoring board for Avalyn, and No other potential conflict of interest relevant to this manuscript. Dr. Flaherty reports grants from Boehringer Ingelheim, royalties from UpToDate, consulting fees from Roche/Genentech, Bellerophonm, Respivant, Shionogi, DevPro, Astra Zeneca, Pure Health, Horizon, Fibrogen, Sun Pharmaceuticals, Pliant, United Therapeutics, Arrowhead, Lupin, Polarean, PureTech, Trevi, CSL Behring, Daewong, Dispersol, Immumet, NeRRe Therapeutics, Insilco; he is also the Steering Committee Chair for the Pulmonary Fibrosis Foundation. Dr. Spino reports grants from NHLBI (1R01HL136682, 1U24HL154946, 1R61HL15840, and 1U24HL145265). Dr. Noth reports grant funding from NIH (NHLBI UG3HL145266), royalties from UpToDate, Licensing fees for Protein Markers in IPF, consulting fees from Boehringer Ingelheim and Sanofi, patents for FVC gene signature predictor, pending patent for PCSK6, and serving on data safety monitoring board for Yale COVID trials. Dr. Martinez reports funding from Afferent/Merck, Bayer, Biogen, Nitto, Novartis, Patara/Respivant, Promedior/Roche, Veracyte for serving on a steering committee for ILD studies, consulting fees from Abvie, Boehringer Ingelheim, BMS, Bridge Biotherapeutics, Csl Behring, DevPro, Genentech, IQVIA, Sanofi, Shionogi, twoXAR, Veracyte, honoraria from United Therapeutics, support for attending meetings from Boehringer Ingelheim, Csl Behring, Patara/Respivant, and participation on data safety monitoring boards for Biogen, and Boehringer Ingelheim.
