A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough

Summary

To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime cough frequency (coughs per hour) at Day 22 (dose 162 mg BID) as compared to placebo tablets.

Timeline

Start

2019-10-29

Primary completion

2022-05-27

Completion

2022-05-27

Publications

• Maher TM, Avram C, Bortey E, Hart SP, Hirani N, Molyneux PL, Porter JC, Smith JA, Sciascia T. Nalbuphine Tablets for Cough in Patients with Idiopathic Pulmonary Fibrosis. NEJM Evid. 2023 Aug;2(8):EVIDoa2300083. doi: 10.1056/EVIDoa2300083. Epub 2023 May 22.

Drugs

Indications