Journal Article

Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant

Martin Nguyen, Allison, Sher, Mandel R., McGarvey, Lorcan P., Muccino, David R., Wu, Wen-Chi, Morice, Alyn H., Birring, Surinder S., Schelfhout, Jonathan, Smith, Jaclyn A., Xu, Zhi Jin

2021

Overview

Purpose This analysis assesses clinical characteristics of patients with refractory chronic cough (RCC) or unexplained chronic cough (UCC) enrolled in a phase 2 study to better understand this patient population. Methods Patients with RCC/UCC lasting for ≥ 1 year and cough severity visual analog scale (VAS) score of > 40 mm at screening were eligible. Demographics, clinical characteristics, and medical history were collected at baseline. Cough-related measures included cough severity VAS, Cough Severity Diary (CSD), Leicester Cough Questionnaire (LCQ), and a structured cough-trigger questionnaire. Medication history included all medications 30 days before screening and chronic cough treatments within 1 year before screening. Data were summarized using descriptive statistics. Results Patients ( N  = 253; female, 76%; mean age, 60 years) had severe (mean cough severity VAS, 57.5 mm) and long-lasting (median duration, 11 years) cough. The most burdensome self-reported aspects included psychological and social factors (LCQ) and cough frequency and intensity (CSD). Patient-reported triggers were consistent with cough hypersensitivity (e.g., 95% to 96% reported irritation or tickle in throat). Common reported comorbidities included gastroesophageal reflux disease (GERD; 56%), allergic rhinitis (47%), and asthma (30%); 12% of patients had been diagnosed with all 3 conditions. The most common prior medications included inhaled or oral steroids (21%), antihistamines (15%), and antacids (15%). Conclusion Patients with RCC/UCC had severe, long-lasting, and burdensome cough with clinical features of cough hypersensitivity. Many patients had been diagnosed with GERD, allergic rhinitis, and asthma but had a persistent cough despite treatment of these conditions. Trial registration: ClinicalTrials.gov, NCT02612610; registered November 20, 2015

• Publisher: Springer US,Springer,Springer Nature B.V
• Subject: Allergic rhinitis / Antacids / Antihistamines / Asthma / Clinical trials / Comorbidity / Cough / Demographics / Demography / Gastroesophageal reflux / Health aspects / Hypersensitivity / Irritation / Mean / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / NCT / NCT02612610 / Patients / Pharmaceutical industry / Pneumology/Respiratory System / Questionnaires / Respiratory agents / Rhinitis / Social factors / Statistical analysis / Steroid hormones / Steroids