A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-Label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough, Including Unexplained Chronic Cough (CALM-1)
A chronic cough can be exhausting, frustrating, and difficult to manage. This Phase 3 clinical study, named CALM-1, is researching a new medicine called BLU-5937 for adults living with an ongoing cough. It focuses on coughs that have lasted for months and either have no clear cause or have failed to improve with standard treatments. Participants will take either the study tablet or a dummy tablet (a placebo) once a day. Neither you nor the study team will know which one you are taking at first. Over 52 weeks, researchers will track how well the tablet works by counting your coughs with a wearable 24-hour monitor and asking you about your daily quality of life. The team will also carefully check for any side effects to confirm whether the treatment is safe and effective.
At a glance
What is this study about?
Coughing is the body's natural way of clearing the airways. However, when a cough lasts for more than eight weeks, it is called a chronic cough. For many people, doctors cannot find an obvious reason for the problem, or normal treatments like inhalers and acid reflux medicines simply do not help. This is known as unexplained or refractory chronic cough. Constant coughing can disrupt sleep, strain chest muscles, and make everyday social situations difficult.
This trial is testing a tablet called BLU-5937. It is designed to calm overactive nerve signals in the throat and lungs that trigger the urge to cough. Researchers hope that by quieting these sensitive nerves, the medicine will help people cough far less often, without causing unpleasant side effects such as losing the sense of taste.
Because this is a Phase 3 trial, the tablet has already been tested in smaller groups of patients with encouraging results. Doctors now need to test it in a much larger group of people over an entire year to confirm that it works and is safe for wider use. If the trial is successful, it could pave the way for a brand-new treatment option for people who have struggled with persistent coughing for a long time.
Key takeaways
- Tests a new daily tablet (BLU-5937) designed to reduce chronic, hard-to-treat coughing.
- Open to adults aged 18 and older with unexplained or treatment-resistant cough.
- Uses a wearable 24-hour monitor to accurately count coughs day and night.
- The main trial lasts 52 weeks, with a potential extension phase to receive the active tablet.
- Participation is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been living with a chronic cough that will not go away. You may be suitable if you have seen a doctor about your cough, but tests have not found a clear cause, or if standard treatments have failed to bring relief.
Both men and women can take part. To join, you will need to be able to take a daily tablet and agree to wear a small, lightweight recording monitor that counts your coughs over a 24-hour period at specific visits.
You may not be able to participate if you have certain other lung conditions or take specific medicines that could interfere with the study results. The study doctors will review your complete medical history and carry out health checks during a screening visit to make sure it is safe for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years of age or older.
- I have had an ongoing cough that has lasted for months.
- My cough has not improved with standard medicines, or doctors cannot find a cause.
- I am able to take a daily tablet by mouth.
- I am willing to wear a small cough recording device for 24 hours at certain visits.
- I can attend regular clinic appointments over a 52-week period.
What does participation involve?
Taking part in the study lasts for about 52 weeks (one year), with the chance to continue taking the study medicine in an extension phase afterwards. You will be asked to take a tablet by mouth every day. To ensure fair results, you will be randomly assigned to receive either the active medicine (BLU-5937) or a dummy pill (placebo).
You will need to attend regular appointments at a study clinic. During these visits, doctors will check your heart rate, blood pressure, and overall health, and you will be asked to complete questionnaires about how coughing affects your daily life. At specific milestones, such as week 12, you will be given a small monitor to wear for 24 hours that listens for and records your coughs while you go about your normal day and sleep.
Potential risks and benefits
Locations (6)
- —UnverifiedNetherlands
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedFrance
Common questions
What does 'unexplained' or 'refractory' chronic cough mean?
It means your cough has lasted for eight weeks or longer, and doctors have either found no underlying reason for it, or standard treatments have not helped it get better.
What is a placebo and why is it used?
A placebo is a dummy pill that looks just like the real medicine but contains no active ingredients. It helps researchers prove whether any improvements are truly caused by the study medicine.
Will I know if I am taking the real medicine or the placebo?
No. This is a 'double-blind' trial, which means neither you nor the study team will know which pill you are taking until this part of the study is finished.
How does the 24-hour cough monitor work?
It is a small, lightweight device that you wear during your normal daily routine. It detects and records the sound of your coughs so the team can accurately measure how often you cough day and night.
Does taking part cost anything?
No, the study medication, health checks, and monitor are provided free of charge. Travel expenses to and from the clinic visits are also usually reimbursed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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