Cough Reduction in IPF with nalbuphine ER (CORAL)
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)
IRAS ID
1008035
Contact name
Katherine Takaki
Contact email
Sponsor organisation
Trevi Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
Idiopathic pulmonary fibrosis (IPF) is a chronic type of pneumonia of unknown cause. Cough is present in approximately 80-85% of patients with IPF. The cough is often severe and very difficult to treat. Currently, there are no treatments approved by the MHRA for cough in patients with IPF. Many previously studied investigational therapies have failed and been abandoned.
This research study will evaluate the safety and effectiveness of nalbuphine extended-release tablets (NAL ER) for the treatment of cough in patients with IPF. The active ingredient in NAL ER is nalbuphine, which binds to ĸ- and µ-opioid receptors that are found in the brain and in the lungs and may play a role in the cough reflex. In a previous proof-of-concept study in patients who had cough associated with IPF, NAL ER reduced daytime cough compared to placebo treatment (a tablet that contains no active ingredients).
The current study is a Phase 2, dose-ranging study in patients with IPF. Three doses of NAL ER will be compared to placebo. Participants will be randomly assigned to receive one of the three doses of NAL ER or placebo for a total of 6 weeks. Neither the doctors nor the participants will know which treatment they receive.
Approximately 160 participants are planned across approximately 75 study sites in 11 countries, including the UK.
To study the effectiveness of NAL ER, participants will wear a cough monitor for a period of 24 hours at different times during the study. Other study procedures include: the completion of questionnaires and safety assessments (physical examination, blood and urine tests, spirometry, and ECGs to measure the electrical activity of the heart).
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0827
Date of REC Opinion
26 Oct 2023
REC opinion
Further Information Favourable Opinion