来自两项慢性咳嗽全球3期试验的人口统计学、临床和患者报告结局数据。
Demographic, clinical, and patient-reported outcome data from 2 global, phase 3 trials of chronic cough.
作者信息
Dicpinigaitis Peter V, Birring Surinder S, Blaiss Michael, McGarvey Lorcan P, Morice Alyn H, Pavord Ian D, Satia Imran, Smith Jaclyn A, La Rosa Carmen, Li Qing, Nguyen Allison Martin, Schelfhout Jonathan, Tzontcheva Anjela, Muccino David
机构信息
Albert Einstein College of Medicine & Montefiore Medical Center, Bronx, New York.
Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, United Kingdom.
出版信息
Ann Allergy Asthma Immunol. 2023 Jan;130(1):60-66. doi: 10.1016/j.anai.2022.05.003. Epub 2022 May 13.
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).
背景
目前对难治性或不明原因慢性咳嗽（分别为RCC和UCC）患者的特征描述主要来自相对较小的临床研究。
目的
报告参与COUGH-1和COUGH-2这两项大型全球3期试验的RCC或UCC患者的基线病史和临床特征，这两项试验是关于P2×3受体拮抗剂gefapixant的试验。
方法
慢性咳嗽持续超过1年、诊断为RCC或UCC且在筛查和基线时100毫米咳嗽严重程度视觉模拟量表评分大于40毫米的成年人符合入组条件。在基线时收集人口统计学、病史和咳嗽特征。与咳嗽相关的测量包括客观咳嗽频率、咳嗽严重程度视觉模拟量表、莱斯特咳嗽问卷和赫尔气道反流问卷。数据采用描述性统计进行汇总。
结果
在2044名参与者中，75%为女性；平均年龄为58岁，平均咳嗽持续时间约为11年。在所有参与者中，73%先前被诊断患有哮喘、胃食管反流病或上气道咳嗽综合征。莱斯特咳嗽问卷的平均总分是10.4，各领域得分反映出在身体、心理和社会领域咳嗽特异性生活质量受损。赫尔气道反流问卷的平均得分是39.6，一些报告的最沉重项目与咳嗽反射高敏反应的特征一致。不同地理区域的参与者特征和咳嗽负担具有可比性。
结论
RCC或UCC患者的特征与已发表的与慢性咳嗽相关的人口统计学特征一致。这些数据反映了一个全球人群，其咳嗽持续时间长且负担沉重，对生活质量有严重损害。
临床试验注册
ClinicalTrials.gov标识符：COUGH-1，NCT03449134（https://www.
临床试验
gov/ct2/show/NCT03449134）；COUGH-2，NCT03449147（https://clinicaltrials.gov/ct2/show/NCT03449147）。
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