Nalbuphine ER for Chronic Cough
(LAKE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of Nalbuphine ER, an extended-release medication, in treating chronic cough unresponsive to other treatments. The study will test various doses to determine the most effective one. Individuals with a persistent cough lasting over a year, who have not found relief from other treatments, may qualify. However, those with a history of smoking or certain lung conditions might not be eligible. The goal is to identify a safe and effective treatment for long-term coughing. As a Phase 2 trial, this research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nalbuphine ER, a long-acting medication, is generally safe for people. Studies have found no serious side effects directly related to the treatment. Common side effects include constipation, sleepiness, nausea, dizziness, and headaches, affecting at least 10% of users. The medication has also been well-tolerated in studies for other conditions, supporting its safety. Overall, current research suggests that nalbuphine ER has a favorable safety profile.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for chronic cough, which often include codeine or dextromethorphan, Nalbuphine ER offers a unique approach by potentially targeting both pain and cough pathways due to its dual action as a kappa-opioid receptor agonist and mu-opioid receptor antagonist. This distinct mechanism could provide relief without the same level of dependency risks associated with traditional opioids. Researchers are excited about Nalbuphine ER because it might offer effective cough suppression while minimizing the side effects typically seen with other opioid-based treatments.
What evidence suggests that Nalbuphine ER could be an effective treatment for chronic cough?
Research has shown that Nalbuphine Extended-Release (NAL ER), which participants in this trial may receive, can effectively reduce chronic cough. In studies, patients using NAL ER experienced a 76.1% reduction in cough frequency over 24 hours, compared to a 25.3% reduction in those taking a placebo (a pill with no active medicine). Another study found a 75.1% decrease in daytime coughing for those on NAL ER. These results suggest that NAL ER significantly helps manage chronic cough, even for people with ongoing symptoms. Overall, the evidence supports NAL ER as a promising treatment for chronic cough.12567
Who Is on the Research Team?
Chief Development Officer
Principal Investigator
Trevi Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults who have had a persistent, unexplained cough for at least one year that hasn't improved with other treatments. Participants must have normal chest scans and lung function tests, and their cough must be frequent (at least 10 times per hour).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Titration
Participants receive NAL ER or placebo with dose titration starting at 27 mg QD and increasing as per assigned group
Fixed-dose Treatment
Participants receive a fixed dose of NAL ER or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nalbuphine Extended-Release (NAL ER)
Trial Overview
The study compares Nalbuphine Extended-Release tablets to a placebo to see if the medication can safely reduce coughing in people with chronic refractory cough. Participants are randomly assigned to either group.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive NAL ER during the titration period, with dose titration starting at 27 milligrams (mg) once daily (QD) and increasing up to 54 mg twice daily (BID) from Day 1 to Day 14. Participants will receive NAL ER 54 mg BID during the fixed-dose treatment period from Day 15 to Day 42.
Participants will receive NAL ER 27 mg QD during the titration period from Day 1 to Day 14. Participants will continue to receive NAL ER 27 mg QD during the fixed-dose treatment period from Day 15 to Day 42.
Participants will receive NAL ER during the titration period, starting at 27 mg QD to 27 mg BID from Day 1 to Day 14. Participants will receive NAL ER 27 mg BID during the fixed-dose treatment period from Day 15 to Day 42.
Participants will receive matching placebo during the titration period from Day 1 to Day 14 and the fixed-dose treatment period from Day 15 to Day 42.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Trevi Therapeutics
Lead Sponsor
Citations
P113 Efficacy and safety of nalbuphine extended-release ...
Cough frequency subgroups of 10–19 and ≥ 20 coughs/hr achieved PBO-adjusted improvements of 75% and 51%, respectively (both P<.0001), with NAL ER at day 21 ( ...
2.
chestphysician.org
chestphysician.org/data-show-oral-nalbuphine-significantly-reduces-chronic-cough-in-idiopathic-pulmonary-fibrosis/Data show oral nalbuphine significantly reduces chronic ...
At six weeks, all nalbuphine ER dose groups demonstrated statistically significant reductions from baseline in objective 24‑hour cough frequency ...
Trevi Therapeutics to Present Final Data from Phase 2 Trial ...
Nalbuphine ER subjects had a 76.1% reduction in 24hr cough frequency compared to a 25.3% of placebo subjects, a 50.8% placebo-adjusted change ( ...
Nalbuphine Tablets for Cough in Patients with Idiopathic ...
There was a 75.1% reduction in daytime objective cough frequency during the NAL ER treatment period versus the placebo treatment period of 22.6% ...
📊 Research Summary: Higher doses of nalbuphine ER led ...
Among patients with idiopathic pulmonary fibrosis and chronic cough, nalbuphine ER achieved dose- dependent reductions in cough and improved ...
Oral Nalbuphine Significantly Reduces Chronic Cough in IPF
The trial demonstrated a favorable safety profile for nalbuphine ER, Common adverse events included headaches, nausea, and vomiting,
NCT04030026 | A Study of Nalbuphine (Extended Release ...
To evaluate the safety and tolerability of nalbuphine ER tablets in the study population and to evaluate the effect of NAL ER tablets on the mean daytime cough ...
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