McGarvey, Lorcan
Smith, Jaclyn A.
Morice, Alyn
Birring, Surinder S.
Chung, Kian Fan
Dicpinigaitis, Peter V.
Niimi, Akio
Benninger, Michael S.
Sher, Mandel
Matsunaga, Yuko
Miyazaki, Sayaka
Machida, Mitsuaki
Ishihara, Hiroyuki
Mahmood, Adnan
Gomez, Juan-Carlos http://orcid.org/0000-0002-0301-5668
Clinical trials referenced in this document:
Documents that mention this clinical trial
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2b Trial of P2X3 Receptor Antagonist Sivopixant for Refractory or Unexplained Chronic Cough
https://doi.org/10.1007/s00408-022-00592-5
Funding for this research was provided by:
Shionogi and Co. Ltd.
Article History
Received: 7 November 2022
Accepted: 7 December 2022
First Online: 13 December 2022
Declarations
:
: LMG has received grants or contracts and consulting fees from Shionogi Inc., Bayer, Merck, Bellus Health, and Chiesi; consulting fees from AstraZeneca, Nocion, Trevi Therapeutics, Reckitt Benckiser Health Limited, NeRRe Therapeutics, and Bionorica; payment or honoraria from Merck, Chiesi, Bellus, Bionorica, GSK, and Shionogi Inc. and participated on a Data Safety Monitoring Board or the Advisory Board for Applied Clinical Intelligence. JAS has served as a consultant and helped in the setup of clinical studies for Shionogi; received grants or contracts from Wellcome Trust investigator award and NIHR Manchester Biomedical Research Centre; her hospital has received royalties from Vitalograph Ltd.; received consulting fee from Bellus Health, Axalbion, Merck, Bayer, Algernon, Nocion, Chiesi, Boehringer Ingelheim, and AstraZeneca; received honoraria from Merck and Boehringer Ingelheim; has a patent issued for cough monitoring; and received equipment supply from Vitalograph Ltd. AMo has received funding from Shionogi; received payment or honoraria from Merck, Bayer, and NeRRe; participated on a Data Safety Monitoring Board or an Advisory Board for Merck, Bayer, NeRRe, Shionogi, and Bellus; and served as the task force chair for the European Respiratory Society. SSB has received personal fees from Shionogi Inc., Merck, Bellus, Bayer, and Nocion. KFC has speaking engagements for Novartis and AstraZeneca; has participated on Advisory Boards for Roche, Merck, Reckitt Benckiser, and Shionogi & Co., Ltd., on asthma, COPD, and chronic cough; serves on Data Safety Monitoring Board for Nocion; and has received grants including MRC grant on Precision Medicine for severe asthma, an EPSRC grant on air pollution and asthma, and a GSK grant on mepolizumab and eosinophils in asthma. PVD has served as a consultant to Bayer, Bellus, Chiesi, Merck, and Shionogi Inc. and is the editor-in-chief of <i>Lung</i>. MSB has served as a consultant for Merck (2020) and Shionogi Inc. (2020) and received research funding from Merck. MS has served on the Medical Advisory Board and as a principal investigator for Bayer, Bellus, Merck, NeRRe, and Shionogi Inc.; serves on the Medical Advisory Board and Data Safety Monitoring Board for Nocion; and is a consultant for Soundable Health. YM is a former employee of Shionogi Inc. SM, MM, and HI are employees of Shionogi & Co. Ltd. JCG is an employee of Shionogi B.V. AMa is a medical consultant for Shionogi B.V. AN has no disclosures.
: The institutional review board at each participating site approved the protocol and other relevant documents. The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
: Written informed consent was obtained from all participants.
: All patients signed an informed consent for publication of data for the present study.
: The sponsor was involved in designing the study; collection, analysis, and interpretation of data; and writing the manuscript.