Evaluating Nalbuphine Extended-Release Tablets for Treating Refractory Chronic Cough in Adults

What this Trial Is About

Researchers are evaluating the efficacy and safety of Nalbuphine ER extended-release tablets in adults with refractory chronic cough RCC, a persistent cough lasting at least one year that has not improved with previous treatments. The study aims to better understand how this medication affects cough frequency and severity in participants whose cough has no clear underlying cause despite thorough investigation. This phase 2 clinical trial uses a randomized, double-blind design to compare different doses of Nalbuphine ER to placebo. Participants are assigned to one of four groups three receive Nalbuphine ER at varying doses during a 14-day titration period followed by a fixed-dose treatment period from Day 15 to Day 42, while the fourth group receives a matching placebo for the same duration. The Nalbuphine ER doses range from 27 mg once daily up to 54 mg twice daily, depending on the assigned group. This schedule allows gradual adjustment to the medication before reaching the fixed dose. During the study, participants will be evaluated using objective cough frequency monitoring over 24 hours, patient-reported assessments of cough frequency and severity, and quality of life questionnaires. Safety will be monitored through tracking treatment-emergent adverse events. The primary outcome is the change in 24-hour cough frequency at Week 6 compared to baseline. Participants are involved in regular monitoring visits throughout the approximately 6-week treatment period, with follow-up to assess tolerability and efficacy.

The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)