Nalbuphine Tablets for Cough in Patients with Idiopathic Pulmonary Fibrosis

BackgroundThere are no approved therapies for cough in patients with idiopathic pulmonary fibrosis (IPF). In this small crossover trial we administered nalbuphine extended-release tablets (NAL ER) as a potential therapy such patients.MethodsThis randomized, double-blind, placebo-controlled, involved two 22-day treatment periods ER→placebo and placebo→NAL separated by 2-week washout period. NAL ER was started at dose of 27 mg once daily titrated up to 162 twice day 16. The primary end point percent change from baseline hourly daytime objective frequency measured an electronic monitor. period defined the patient-reported time awakening bedtime. Secondary points included 24-hour frequency, changes severity, breathlessness, per outcomes.ResultsA total 41 were randomly assigned received one or more doses study medication. There 75.1% reduction during versus placebo 22.6%, 52.5 percentage placebo-adjusted decrease (P<0.001) 21. 76.1% (95% confidence interval, 83.1 69.1) ER, 25.3% (43.9 6.7) placebo, 50.8 change. Nausea, fatigue, constipation, dizziness common than placebo.ConclusionsIn short-term trial, reduced individuals IPF. Larger longer trials needed assess impact on drug adverse effects. (Funded Trevi Therapeutics; ClinicalTrials.gov number, NCT04030026.)