TY - JOUR
T1 - Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough
AU - Dicpinigaitis, Peter V
AU - Birring, Surinder S
AU - Blaiss, Michael
AU - McGarvey, Lorcan P
AU - Morice, Alyn H
AU - Pavord, Ian D
AU - Satia, Imran
AU - Smith, Jaclyn A
AU - La Rosa, Carmen
AU - Li, Qing
AU - Nguyen, Allison Martin
AU - Schelfhout, Jonathan
AU - Tzontcheva, Anjela
AU - Muccino, David
N1 - Funding Information:
Funding: This study was supported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, New Jersey.
Funding Information:
Disclosures: Dr Dicpinigaitis has received advisory board and/or consultancy fees from Bayer HealthCare Pharmaceuticals, Bellus Health Inc, Chiesi, Merck Sharp & Dohme Corp, and Shionogi. Dr Birring has received advisory board and/or consultancy fees from Bayer, Bellus, Merck & Co, Inc, NeRRe, and Shionogi; and grant support from Merck & Co, Inc. Dr Blaiss has served as a consultant for ALK-Abelló, Amgen, Bellus, Covis, Pfizer, Regeneron, Sanofi, and TerSera. Dr McGarvey has received advisory board and/or consultancy fees from Applied Clinical Intelligence, Bayer, Bellus Health, Bionorica, Chiesi, Merck, Nocion Therapeutics, and Shionogi. Dr Morice has received consultancy fees from Bayer, Bellus, Boehringer Ingelheim, Merck, Pfizer, Proctor & Gamble, and Shionogi; lecturing fees from AstraZeneca and Boehringer Ingelheim; and grant support from Afferent, Infirst, Merck, and Proctor & Gamble. Dr Pavord has received personal fees from Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Genentech, GlaxoSmithKline, Knopp, Novartis, Regeneron, Sanofi, and Teva; and grant support from the NIHR. Dr Satia has received personal fees from educational talks for general practitioners from AstraZeneca; grants and personal fees from Merck Canada and GlaxoSmithKline; consulting fees from Genentech; a European Respiratory Society Respire 3 Marie Curie Fellowship; and an E.J. Moran Campbell Early Career Award from the Department of Medicine, McMaster University (outside the submitted work). Dr Smith has received personal fees from Bayer, Bellus Healthcare, Boehringer Ingelheim, GlaxoSmithKline, Menlo, NeRRe Pharmaceuticals, and Shionogi; nonfinancial support from Vitalograph; grant support and personal fees related to the submitted work from Afferent Pharmaceuticals and/or Merck & Co, Inc; and grant support from Bayer, Bellus, GlaxoSmithKline, Menlo, and NeRRe Pharmaceuticals. The VitaloJAK algorithm is owned by Manchester University National Health Service Trust and licensed to Vitalograph Ltd; Manchester University National Health Service Trust receives royalties from Vitalograph, which may be shared with the department in which Dr Smith works. Dr Smith is also funded by the NIHR Manchester Biomedical Research Centre and a Wellcome Investigator Award and is an NIHR Senior Investigator. Dr Rosa, Dr Li, Ms Nguyen, Dr Schelfhout, Dr Tzontcheva, and Dr Muccino are employees of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, New Jersey. Funding: This study was supported by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co, Inc, Kenilworth, New Jersey.
Publisher Copyright:
© 2022 The Authors
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
PY - 2023/1
Y1 - 2023/1
N2 - BACKGROUND: The current characterization of patients with refractory or unexplained chronic cough (RCC and UCC, respectively) primarily stems from relatively small clinical studies.OBJECTIVE: To report the baseline medical history and clinical characteristics of individuals with RCC or UCC who were enrolled in COUGH-1 and COUGH-2, 2 large, global, phase 3 trials of gefapixant, a P2 × 3-receptor antagonist.METHODS: Adults with a chronic cough lasting for more than 1 year, diagnosis of RCC or UCC, and score greater than 40 mm on a 100-mm cough severity visual analog scale at both screening and baseline were eligible for enrollment. Demographics, medical history, and cough characteristics were collected at baseline. Cough-related measures included objective cough frequency, cough severity visual analog scale, Leicester Cough Questionnaire, and Hull Airway Reflux Questionnaire. The data were summarized using descriptive statistics.RESULTS: Of 2044 participants, 75% were women; mean age was 58 years, and mean cough duration was approximately 11 years. Among all participants, 73% were previously diagnosed with asthma, gastroesophageal reflux disease, or upper airway cough syndrome. The mean Leicester Cough Questionnaire total score was 10.4, with domain scores reflecting impaired cough-specific quality of life across physical, psychological, and social domains. The mean Hull Airway Reflux Questionnaire score was 39.6, with some of the most burdensome reported items being consistent with features of cough-reflex hypersensitivity. Participant characteristics and cough burden were comparable across geographic regions.CONCLUSION: Participants with RCC or UCC had characteristics consistent with published demographics associated with chronic cough. These data reflect a global population with burdensome cough of long duration and substantial impairment to quality of life.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: COUGH-1, NCT03449134 (https://www.CLINICALTRIALS: gov/ct2/show/NCT03449134); COUGH-2, NCT03449147 (https://clinicaltrials.gov/ct2/show/NCT03449147).
AB - BACKGROUND: The current characterization of patients with refractory or unexplained chronic cough (RCC and UCC, respectively) primarily stems from relatively small clinical studies.OBJECTIVE: To report the baseline medical history and clinical characteristics of individuals with RCC or UCC who were enrolled in COUGH-1 and COUGH-2, 2 large, global, phase 3 trials of gefapixant, a P2 × 3-receptor antagonist.METHODS: Adults with a chronic cough lasting for more than 1 year, diagnosis of RCC or UCC, and score greater than 40 mm on a 100-mm cough severity visual analog scale at both screening and baseline were eligible for enrollment. Demographics, medical history, and cough characteristics were collected at baseline. Cough-related measures included objective cough frequency, cough severity visual analog scale, Leicester Cough Questionnaire, and Hull Airway Reflux Questionnaire. The data were summarized using descriptive statistics.RESULTS: Of 2044 participants, 75% were women; mean age was 58 years, and mean cough duration was approximately 11 years. Among all participants, 73% were previously diagnosed with asthma, gastroesophageal reflux disease, or upper airway cough syndrome. The mean Leicester Cough Questionnaire total score was 10.4, with domain scores reflecting impaired cough-specific quality of life across physical, psychological, and social domains. The mean Hull Airway Reflux Questionnaire score was 39.6, with some of the most burdensome reported items being consistent with features of cough-reflex hypersensitivity. Participant characteristics and cough burden were comparable across geographic regions.CONCLUSION: Participants with RCC or UCC had characteristics consistent with published demographics associated with chronic cough. These data reflect a global population with burdensome cough of long duration and substantial impairment to quality of life.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: COUGH-1, NCT03449134 (https://www.CLINICALTRIALS: gov/ct2/show/NCT03449134); COUGH-2, NCT03449147 (https://clinicaltrials.gov/ct2/show/NCT03449147).
KW - Adult
KW - Carcinoma, Renal Cell/complications
KW - Chronic Disease
KW - Clinical Trials, Phase III as Topic
KW - Cough/drug therapy
KW - Female
KW - Gastroesophageal Reflux
KW - Humans
KW - Kidney Neoplasms/complications
KW - Male
KW - Middle Aged
KW - Quality of Life
UR - http://www.scopus.com/inward/record.url?scp=85136248516&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/16208f2c-ecd5-32b0-8b4a-dd2e49e67ded/
U2 - 10.1016/j.anai.2022.05.003
DO - 10.1016/j.anai.2022.05.003
M3 - Article
C2 - 35569802
SN - 1534-4436
VL - 130
SP - 60
EP - 66
JO - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
IS - 1
ER -