New research found that gefapixant is associated with a significant reduction in cough frequency in people with unexplained chronic cough.
Using the results of 2 large, phase 3 clinical trials — COUGH-1 and COUGH-2 — researchers presented a pooled analysis of objective cough frequency following treatment with gefapixant, a P2X3 receptor antagonist associated with significant reduction in 24-hour cough frequency.
The 2 companion studies (ClinicalTrials.gov Identifiers: NCT03449134 and NCT03449147), included participants aged 18 years and older with 1 year or more of chronic cough, a diagnosis of chronic cough refractory to treatment for associated conditions (RCC) or chronic cough unexplained with no associated condition (UCC), and a baseline cough severity Visual Analogue Scale (VAS) score or 40 mm or more. Participants were randomly assigned to receive either placebo, gefapixant 15 mg twice daily, or gefapixant 45 mg twice daily.
The VitaloJAK™ (Vitalograph Inc) ambulatory recording device was used to record cough frequency; data were analyzed via both software and human analysts. Objective cough frequency endpoints included both 24-hour cough frequency and Awake Cough Frequency (coughs per hour during waking hours).
“The pooled analysis of COUGH-1 and COUGH-2 is the largest prospective analysis of clinical trial data in chronic cough to date,” the researchers concluded. “Gefapixant 45 mg provided clinically important reduction in cough frequency vs placebo and was not associated with an increase in serious adverse events.”