Actively Enrolling -
Refractory Chronic Cough Trial
The LAKE trial is a Phase 2b clinical trial seeking to understand different doses of an investigational treatment, oral nalbuphine ER (extended-release) (NAL ER), and its potential effects on cough in patients with Refractory Chronic Cough (RCC).
The LAKE Trial
Who Can Join
Patients 18 and older suffering from a persistent cough for at least one year.
What to Expect
Participation in this trial will take approximately 13 weeks and include taking an oral study drug (NAL ER or placebo).
Where it is Taking Place
Canada, Poland, and the United Kingdom.
There is no cost to participate. You will be reimbursed for your time and trial-related expenses such as transportation costs and meals. In the LAKE trial, you will receive trial-related medical care from a dedicated team of healthcare providers.
Is the LAKE Trial Right for You?
To be able to take part in the LAKE trial, you must meet the following criteria:
- Adults 18 and older
- Have had a persistent cough for at least one year
Please note that this list above does not include all of the criteria. If you are able to participate, all further trial procedures will take place at the trial site with the Trial Doctor/Trial Team. The Trial Doctor will tell you if you are able to participate in this trial.
What is Refractory Chronic Cough?
Refractory chronic cough is a persistent cough lasting more than eight weeks that does not get better with most medicines for common causes like asthma, reflux, or allergies.
10% of adults suffer from chronic cough and patients see a number of specialized doctors to help treat this condition.
*Behr J. Et al., DOI: 10.1183/23120541.00926-2024.
Why is it Important to Participate in Clinical Trials?
Clinical trials can only take place when patients with a certain disease or condition choose to participate. Examples of reasons patients choose to join clinical trials include:
1. To play a more active role in their own health care
2. To gain deeper understanding about their disease
3. To help find new or better treatments
Why Join the LAKE Trial?
By participating in the LAKE trial, it will help researchers to expand on their understanding of the efficacy and safety of oral NAL ER in patients with RCC.
The Trial at a Glance
Enrollment in the trial for approximately 13 weeks.
7 in-person visits to the trial location.
Taking an oral study drug (NAL ER or placebo).
A dedicated team who will monitor you throughout the trial.
Comprehensive medical testing, periodically wearing a cough monitor, and completing electronic questionnaires.
No cost to participate. You will be reimbursed for your time and trial-related expenses such as transportation costs and meals.
What to Expect During the Trial
The trial will take approximately 13 weeks and includes screening, placebo run-in, treatment, and follow‑up. During this time, you will have seven in‑person visits for medical testing, periodically wear a cough monitor, and you will be asked to complete electronic questionnaires on a tablet that the trial team will provide.
Part 1
Screening
The trial team will check to see if you are a good fit for the trial.
Placebo Run-In: If you qualify, you will take a placebo for two weeks. This is to help you become accustomed to taking the study drug twice daily before you start the main part of the trial.
Up to 4 Weeks
(including a 2-week placebo run-in)
Part 2
Treatment
If you’re selected to continue, you’ll begin taking the study drug (either NAL ER or placebo).
- Weeks 1–2: Your dose will gradually increase to help your body adjust.
- Weeks 3–6: You will stay on a steady dose for the rest of the trial.
6 Weeks
Part 3
Follow-up
Once you have completed treatment, the trial team will follow up with you periodically by phone with additional questions.
3 Weeks
What is a placebo and why is it used?
The purpose of a placebo is to show if the investigational treatment is working. The placebo looks identical to the investigational treatment but contains no active ingredients.
Once through the placebo run-in period, patients will be randomly assigned to one of four treatment groups:
- oral NAL ER 27 mg once a day
- oral NAL ER 27 mg twice a day
- oral NAL ER 54 mg twice a day
- oral placebo
Three out of every four participants will receive a dose of oral NAL ER.
This trial is double-blinded which means both the participant and clinical trial staff do not know which treatment group they are in.
Find a LAKE Trial Location Near You
Click on a marker to find a trial location near you. Use the contact details to call or email your closest trial location. If you are not located near a trial location but are willing to travel, trial staff will provide reimbursement for travel expenses.
Trial Locations
Thank you for considering participation in the LAKE trial for the treatment of patients with RCC.
More information about this clinical trial can be found on ClinicalTrials.gov/study/NCT07671924
Doctor Referral Card
Interested in discussing this trial with your doctor? Use the following button to access the Doctor Referral Card. Take a picture or print out the card to bring with you when you speak to your doctor about the LAKE trial.
Frequently Asked Questions
What is a clinical trial?
A clinical trial is medical research aimed at understanding if investigational treatments work and if they are safe. All investigational treatments must undergo testing and obtain regulatory approval or authorization before they can be prescribed. Strict regulations ensure ethical treatment of participants. Trials are conducted by a team of healthcare professionals, typically funded by pharmaceutical companies.
Is there cost to participate?
Your participation is valuable. There is no cost to participate. You will be reimbursed for your time and trial-related expenses such as transportation costs and meals.
What oversight goes into clinical trials?
Before human studies are conducted sponsors must submit a trial plan and safety documentation to local health authorities and ethics committees, who must approve it before the trial can start.
What is nalbuphine ER and how does it work?
Nalbuphine ER (NAL ER) is an investigational oral medication being studied for the treatment of refractory chronic cough (RCC). NAL ER may help decrease the number of times a person coughs by working in the lungs and central nervous system. NAL ER was previously studied in a Phase 2 clinical trial in patients with RCC.
Are there any potential risks if I join the LAKE trial?
Your safety is a priority. Your trial team will explain all the potential benefits and risks involved with participation in the trial, and you will have the chance to consider this carefully before deciding whether or not to participate.