Efficacy of oral nalbuphine extended release in patients with idiopathic-pulmonary-fibrosis-related chronic cough: A Phase 2 study

This randomized, double-blind, Phase 2 crossover trial compared the efficacy of extended-release oral nalbuphine versus placebo in 42 patients with IPF-related chronic cough. The primary endpoint was the mean percent change from baseline in the hourly daytime cough frequency; secondary endpoints included cough frequency over 24 hours and cough frequency per the patient-completed EXACT2 questionnaire. Objective measurement of cough was undertaken using the Vitalograph VitaloJAK cough monitor.