Sample size re-estimation in an ongoing dose-ranging study of nalbuphine extended-release for cough in idiopathic pulmonary fibrosis: The CORAL study

This paper described the design of an ongoing randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b dose-ranging study that will evaluate the efficacy and safety of three doses of extended-release nalbuphine tablets for the management of cough in patients with IPF. The primary endpoint is the relative change from baseline to Week 6 in 24-hour cough frequency with nalbuphine versus placebo, measured using the Vitalograph VitaloJAK digital cough monitor.