Efficacy and safety of nalbuphine extended-release tablets for the treatment of refractory chronic cough: A Phase 2 trial in progress

This paper described the design of an ongoing double-blind, randomized, placebo-controlled, 2-period crossover study that will evaluate the efficacy and safety of extended-release nalbuphine tablets for the management of refractory chronic cough. During the study, cough will be objectively measured on three occasions using the Vitalograph VitaloJAK electronic cough monitor. Collected data will be used to determine the relative change from baseline in 24-hour cough frequency, the proportion of responders with a ≥30%, ≥50%, or ≥75% reduction in 24-hour cough frequency, and the relative change from baseline in awake and sleep cough frequency.