Schelfhout, Jonathan
Nguyen, Allison Martin
Birring, Surinder S.
Bacci, Elizabeth D.
Vernon, Margaret
Muccino, David R.
La Rosa, Carmen
Smith, Jaclyn A.
Funding for this research was provided by:
Merck Sharp & Dohme LLC
Article History
Received: 8 September 2022
Accepted: 19 October 2022
First Online: 8 November 2022
Declarations
:
: JS, AMN, DRM, and CL are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may hold stock or stock options in Merck & Co., Inc., Rahway, NJ, USA. SSB reports grants from Merck & Co., Inc.; personal fees for advisory board work from Bayer, Bellus, GSK, Menlo, Merck & Co., Inc., Nocion, Sanofi, and Shionogi; and reimbursement for travel expenses from Boehringer Ingelheim. EDB is an employee of Evidera, which provides consulting and other research services to pharmaceutical, medical device, and related organizations. In her salaried position, she works with a variety of companies and organizations and is precluded from receiving payment or honoraria directly from these organizations for services rendered. Evidera received funding from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, to participate in the study and the development of this manuscript. MV reports nonfinancial support from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and personal fees from Evidera during the conduct of the study. JAS reports grants and personal fees related to the submitted work from Afferent Pharmaceuticals/Merck & Co., Inc.; grants from Ario Pharma, Bayer, Bellus, GlaxoSmithKline, Menlo, and NeRRe Pharmaceuticals; personal fees from Ario Pharma, Bayer, Bellus, Boehringer Ingelheim, Chiesi, Genentech, GlaxoSmithKline, Menlo, Neomed, and NeRRe Pharmaceuticals; nonfinancial support from Vitalograph; and is a named inventor on a patent, owned by Manchester University NHS Foundation Trust and licensed to Vitalograph Ltd, describing the detection of cough from sound recordings.
: The phase 2b study (ClinicalTrials.gov, NCT02612610) was approved by the Investigational Review Boards or Ethics Review Committees of the 44 study centers in the UK and USA, and done in accordance with the principles of Good Clinical Practice.
: Patients gave written informed consent before enrollment.