Cough Reduction in IPF With Nalbuphine ER

Summary

The main purpose of the study is to evaluate the effect of NAL ER on 24-hour cough frequency using objective digital cough monitoring and to assess safety and tolerability of NAL ER.

Timeline

Start

2024-02-06

Primary completion

2025-04-24

Completion

2025-04-24

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs NAL ER 27 mg; p = 0.0028; Least square (LS) mean difference -0.71 (95% CI -1.17 to -0.25) NCT05964335 ↗

registry analysis (superiority test); Placebo vs NAL ER 54 mg; p = 0.0000; Least square (LS) mean difference -1.08 (95% CI -1.55 to -0.61) NCT05964335 ↗

registry analysis (superiority test); Placebo vs NAL ER 108 mg; p = 0.0000; Least square (LS) mean difference -1.14 (95% CI -1.61 to -0.67) NCT05964335 ↗

Publications

• Molyneaux PL, Mogulkoc N, Gunen H, Doboszynska A, Kreuter M, Neustifter B, Mathur V, Cassella J; CORAL Study Group. Oral Nalbuphine in Idiopathic Pulmonary Fibrosis-Associated Cough: The CORAL Randomized Clinical Trial. JAMA. 2026 Mar 24;335(12):1050-1059. doi: 10.1001/jama.2025.26179.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nalbuphine	Small molecule	27 mg	Oral
Subject	Nalbuphine	Small molecule	54 mg	Oral
Subject	Nalbuphine	Small molecule	108 mg	Oral

Indications