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

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

Abstract

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 ≥ 1year and cough severity visual analog scale (VAS) score of > 40mm 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 30days before screening and chronic cough treatments within 1year before screening. Data were summarized using descriptive statistics. Results: Patients (N = 253; female, 76%; mean age, 60years) had severe (mean cough severity VAS, 57.5mm) and long-lasting (median duration, 11years) 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

Citation

Morice, A. H., Birring, S. S., Smith, J. A., McGarvey, L. P., Schelfhout, J., Martin Nguyen, A., …Sher, M. R. (2021). Characterization of Patients With Refractory or Unexplained Chronic Cough Participating in a Phase 2 Clinical Trial of the P2X3-Receptor Antagonist Gefapixant. Lung, 199(2), 121-129. https://doi.org/10.1007/s00408-021-00437-7

• Journal Article Type: Article
• Acceptance Date: Mar 6, 2021
• Online Publication Date: Apr 7, 2021
• Publication Date: 2021-04
• Deposit Date: May 12, 2022
• Publicly Available Date: May 12, 2022
• Journal: Lung
• Print ISSN: 0341-2040
• Electronic ISSN: 1432-1750
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 199
• Issue: 2
• Pages: 121-129
• DOI: https://doi.org/10.1007/s00408-021-00437-7
• Keywords: Persistent cough; Troublesome cough; Refractory cough; Idiopathic chronic cough; Cough hypersensitivity syndrome
• Public URL: https://hull-repository.worktribe.com/output/3750168