Trialling Nalbuphine ER as a treatment for Cough in Idiopathic Pulmonary Fibrosis

A research team led by Philip Molyneaux, Professor of Interstitial Lung Disease at the NHLI, recently completed a successful phase two clinical trial into the use of Nalbuphine ER as a treatment for cough in patients living with Idiopathic Pulmonary Fibrosis (IPF).

IPF is a scarring lung disease with a life expectancy of around three and a half years. Around 80% of IPF patients suffer with chronic cough, for which there is currently no treatment. Previous studies have shown that cough can contribute to anxiety and depression in IPF patients and in severe cases, can lead to incontinence and blackouts. 

In the phase two trial, 165 IPF patients with chronic cough were either given one of three different strength doses of Nalbuphine ER, or a placebo, for six weeks. Coughs-per-hour were recorded for each patient over the first and last 24 hours of the study; the cough count dropped across all three doses of the drug compared to the placebo, with the strongest dose proving to be the most effective. Patients were also asked about their own perception of the rate and severity of their cough, with those taking the two stronger doses of the drug noticing a significant decrease in their symptoms. 

The trial, which recruited at the Royal Brompton Hospital’s Cardiorespiratory clinical research facility, is the first positive head-to-head placebo-controlled study into IPF cough. It is set to be followed by a phase three trial later this year, looking at a larger patient population for a longer duration. 

Speaking about the research, Professor Molyneaux said, “Our research shows that the mechanisms we are targeting improve cough, helping us to gain a deeper understanding of IPF and its symptoms.” 

When asked about questions subsequent research may aim to answer, he said, “While we can now potentially improve a patient’s quality of life, we don’t know if reducing cough can slow disease progression, nor do we know why some IPF patients cough more than others. Hopefully we will be able to answer these questions with the upcoming study. 

“Moreover, we are currently only looking at idiopathic pulmonary fibrosis, so there is a possibility that Nalbuphine ER may work for those living with non-idiopathic or familial pulmonary fibrosis too.” 

You can read the full interview with Professor Molyneaux on the NHLI blog. 

You can also read the full paper, published in JAMA.