Positive results from IPF chronic cough trial

We are delighted to share news of a significant milestone in idiopathic pulmonary fibrosis (IPF) research — and to say a heartfelt thank you to all the patients from our community who took part in this important study. 

The CORAL clinical trial, led by Trevi Therapeutics has reported positive top-line results in its investigation of a new treatment — Haduvio (oral Nalbuphine ER (extended release)) — for chronic cough in people living with IPF.  CORAL stands for COugh Reduction in IPF with nALbuphine ER.

What the Trial Found

• This Phase 2b trial involved 165 patients with IPF-related chronic cough across multiple centres, including patients at University College London Hospital.
• The treatment significantly reduced cough frequency: Patients receiving Haduvio experienced up to a 60% reduction in 24-hour cough frequency by week 6 of treatment.
• The highest dose group saw a 43.3% greater reduction compared to placebo.
• Improvements were seen early: Benefits were already noticeable by week 2, the earliest measurement point.
• Most patients had a meaningful response: Around 65% of patients on the highest dose had at least a 50% reduction in coughing, compared to only 19% in the placebo group.
• Patient-reported outcomes improved too: Patients on the medium and high doses also reported significantly better scores on cough severity and the impact on daily life.
• The treatment was well-tolerated: Side effects were manageable and discontinuation rates were similar to placebo.

Why This Matters

Chronic cough affects up to 85% of people with IPF, often with no effective treatment options. Many patients describe coughing as one of the most disruptive and isolating symptoms of the disease. For the first time, we now have clear evidence that a targeted treatment — Haduvio — may offer substantial relief.

A Sincere Thank You

To the patients who participated in this trial, along with their families, your involvement helped make this breakthrough possible. You gave your time, your trust and your health experience to support research that could change lives. We are so grateful for your courage and generosity.

Some of the UCLH research team are funded by Breathing Matters and played a role in this important study – we thank you too.

What’s Next?

Trevi Therapeutics is now preparing for a Phase 3 trial in 2026 and will be meeting with the FDA to plan the next stage. We will continue to keep you informed and look forward to supporting further research as it develops.

You can read the full press release from Trevi Therapeutics here.

 

[Posted June 2025]