Active not recruitingPHASE3INTERVENTIONAL

A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

This study is looking at a new medicine called BLU-5937 for adults in the UK who have a stubborn cough that has lasted for over a year and hasn't improved with other treatments. This type of cough is often called a 'refractory chronic cough.' The study will compare BLU-5937 to a 'dummy' pill (placebo) to see if it can effectively reduce how often people cough over 24 weeks. Participants won't know if they are receiving the medicine or the dummy pill, and neither will their study doctor. This helps us get clearer results about the medicine's effects and its safety. If you're an adult between 18 and 80 with this kind of cough, you might be able to take part.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bellus Health Inc. - a GSK company

Enrolment target

975

Start

05 Dec 2022

Estimated completion

17 Mar 2027

Cough Refractory Chronic Cough

What is this study about?

This research study is about finding a new way to help adults who suffer from a very persistent cough. This isn't just any cough, but one that has lasted for at least a year and hasn't gotten better with standard treatments. Doctors often call this a 'refractory chronic cough,' and sometimes the cause isn't even known.

The study is testing a medicine called BLU-5937. We want to see if this medicine can help reduce how often people cough throughout the day and whether it's safe to use. Half of the participants will receive BLU-5937, and the other half will receive a 'placebo' – a pill that looks exactly like the study medicine but contains no active ingredient. This comparison helps us understand if any improvements are genuinely due to the medicine or just the effect of being in a study. The study will last for 24 weeks, during which we'll closely monitor participants' coughs and their general health.

Finding better treatments for chronic cough is really important because it can significantly affect daily life, sleep, and overall well-being. This study aims to contribute to developing new options for people who currently have limited choices for managing their persistent cough.

Key takeaways

Tests a new medicine (BLU-5937) for persistent, hard-to-treat cough.
Compares the medicine to a dummy pill to see if it reduces coughing.
For adults aged 18-80 with a cough lasting over a year.
Study lasts 24 weeks with regular check-ups.
Participation is voluntary, and you can leave at any time.
Aims to find new options for chronic cough sufferers.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old who has been experiencing a persistent cough for at least one year that hasn't improved with other treatments.

There are certain conditions that would mean you can't take part. For example, you shouldn't be currently smoking or vaping, or have stopped within the last six months. Also, if you have certain lung conditions like severe asthma, COPD, or cystic fibrosis, or have had a recent chest infection, you wouldn't be able to join. We also wouldn't be able to include someone who has been diagnosed with certain serious illnesses in the last five years, or has a history of substance abuse in the past three years.

If you're a woman who could become pregnant, you would need to use effective contraception throughout the study and for a short time after your last dose of the study medicine. This is to ensure maximum safety.

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.

Are you between 18 and 80 years old?
Have you had a cough that has lasted for at least one year and hasn't responded to other treatments?
Are you a non-smoker/non-vaper (or stopped at least 6 months ago)?
Have you been free from recent chest infections (past 4 weeks) and serious lung conditions?
Are you willing to use effective contraception if you are a woman who could become pregnant?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would receive either the new medicine, BLU-5937, or a dummy pill, for 24 weeks. You wouldn't know which one you're taking, and neither would your study doctor. You would have regular appointments at the clinic for health checks, to discuss your cough symptoms, and to ensure you're doing well. These visits would involve various assessments, which might include questionnaires, physical examinations, and possibly some blood tests. The total duration of your involvement in the study, including follow-up visits after you stop taking the medicine, would be explained in full detail by the study team.

Potential risks and benefits

Participating in this study might offer the potential benefit of improving your chronic cough if you receive the active medicine. However, there's also a chance you could receive the dummy pill, and your cough might not improve. While all medicines carry some risks of side effects, the study will closely monitor your health to identify and manage any potential issues. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (252)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
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Foley, United States
GSK Investigational Site
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Litchfield Park, United States
GSK Investigational Site
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Phoenix, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Los Angeles, United States
GSK Investigational Site
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Paramount, United States
GSK Investigational Site
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Redding, United States
GSK Investigational Site
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Sacramento, United States
GSK Investigational Site
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San Diego, United States
GSK Investigational Site
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San Diego, United States
GSK Investigational Site
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San Jose, United States
GSK Investigational Site
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Aurora, United States

Common questions

What is 'refractory chronic cough'?

It's a persistent cough that has lasted for over a year and hasn't responded well to standard treatments, even when the cause isn't clear.

Will I know if I'm getting the real medicine or a dummy pill?

No, both you and the study doctors will not know if you are receiving BLU-5937 or the dummy pill. This helps ensure the study results are fair and accurate.

How long will the study last for me?

The main treatment part of the study is 24 weeks. The total length of your participation, including follow-up, will be clearly explained by the study team.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, without it affecting your usual medical care.

Are there any costs for me to participate?

Taking part in a clinical trial does not typically involve any costs to you. Any study-related visits or medications will be provided as part of the study.