A Phase 3, 24-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-2)
A chronic cough is one that lasts for eight weeks or more. Sometimes, coughing continues even after trying different treatments, or doctors cannot find a clear medical cause. This Phase 3 trial, called CALM-2, is testing a new medicine called BLU-5937 to see if it can help adults manage this persistent cough. Participants will take either BLU-5937 tablets or dummy tablets (placebo) every day for 24 weeks. During the study, people will wear a special digital cough monitor for 24 hours at a time to count how many times they cough. Doctors will also check the safety of the medicine through regular health checks, blood tests, and heart tracings (ECGs). After 24 weeks, participants may be offered the chance to continue taking BLU-5937 in an extension study.
At a glance
What is this study about?
Coughing is an important reflex that protects our lungs, but a cough that lasts for months can be exhausting, painful, and disruptive to everyday life. When a long-lasting cough does not get better after standard medical treatments, or when doctors cannot find a specific reason for it, it is called a refractory or unexplained chronic cough. There are currently very few treatments available to help people with this frustrating condition.
This trial is looking at a new tablet called BLU-5937. It is designed to calm overactive nerve signals between the airway and the brain that trigger the urge to cough. Researchers want to find out whether taking BLU-5937 can noticeably reduce daily coughing compared to a dummy tablet, known as a placebo. Because this is a Phase 3 trial, the medicine has already passed earlier safety checks and is now being tested in a larger group of patients to confirm whether it works well.
The main 24-week period is 'double-blind', meaning neither you nor your study doctor will know whether you are taking BLU-5937 or the placebo. This helps make sure the trial results are completely fair. Once this main period finishes, participants may be invited to join an 'open-label extension', where everyone receives the active medicine.
If successful, this research could lead to a brand-new treatment option for thousands of people living with chronic cough who currently have little to no relief.
Key takeaways
- Tests a new medicine, BLU-5937, for chronic cough that hasn't responded to usual treatments.
- The main trial lasts 24 weeks, comparing the medicine against a dummy pill (placebo).
- Coughing is tracked accurately using a wearable 24-hour recording device.
- Participants may have the chance to join an extension study where everyone receives the active drug.
- Safety is monitored through regular health checks, ECGs, and blood tests.
Who may be eligible?
This trial is open to adults aged 18 and older who have been living with a chronic cough for a long time. It is specifically designed for people whose cough has not improved with standard medical care, or where thorough medical checks have not revealed an obvious cause.
Both men and women may be able to join. However, you will need to undergo a medical screening with the study doctor to make sure your cough is not caused by an active lung disease (such as severe uncontrolled asthma or a recent chest infection) or certain types of medication.
If you are interested, the trial team will review your full medical history, ask about current medicines you take, and perform basic health checks to ensure taking part is safe for you.
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 cleared up despite trying standard treatments.
- My doctor has not found an obvious cause for my cough, or previous treatments have failed.
- I am able and willing to attend regular clinic visits and wear a cough monitor.
What does participation involve?
If you take part, your participation will last for at least 24 weeks, with the possibility of staying on longer for an extension study. You will be asked to take a tablet by mouth twice a day. Half of the participants will receive the study medicine, and half will receive a dummy tablet (placebo).
Throughout the 24 weeks, you will visit the hospital or clinic regularly. At these visits, doctors will check your blood pressure, listen to your chest, carry out heart rhythm tracings (ECGs), and take routine blood and urine samples. You will also be asked to fill in questionnaires about your cough and how it affects your quality of life.
To see if the medicine works, you will occasionally wear an unobtrusive audio recording device on your body for 24 hours. This device listens for and counts your coughs while you go about your normal day and while you sleep.
Potential risks and benefits
Locations (4)
- —UnverifiedGermany
- —UnverifiedSlovakia
- —UnverifiedCzechia
- —UnverifiedPoland
Common questions
What is a placebo?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps scientists tell whether any improvements or side effects are truly caused by the study drug.
How does the cough monitor work?
It is a small, lightweight device worn on your clothing that records sound to detect and count every time you cough over a 24-hour period. It is designed to be comfortable and easy to wear during your normal routine.
Will I definitely get the active medicine?
During the first 24 weeks, a computer decides at random whether you receive the active medicine or a placebo. However, if you choose to enter the extension phase after 24 weeks, all participants will receive the active study medicine.
Will taking part cost me anything?
No, the study medicine and all trial-related tests are provided free of charge. Most trials also reimburse reasonable travel expenses to and from the clinic.
Can I stop taking part if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason, without giving an explanation. Your regular NHS doctors will continue to look after you as normal.
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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