A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
This study is looking into a new medication, BLU-5937, for adults who have a chronic cough that hasn't improved with other treatments, also known as refractory chronic cough. We want to find out if BLU-5937 can help reduce how often these individuals cough over a period of 12 weeks. Participants will be randomly assigned to receive either BLU-5937 or a placebo (a pill with no active medicine), and neither they nor their doctors will know which treatment they are getting. This helps us ensure the results are fair and accurate. The study will last for 52 weeks in total and carefully monitor both the effectiveness and safety of the new medicine.
At a glance
What is this study about?
This study is designed to explore a new potential treatment, called BLU-5937, for people who suffer from a very persistent cough that hasn't cleared up with typical medications. This kind of cough is often called 'refractory chronic cough' or 'unexplained chronic cough.' It can be very frustrating and significantly impact daily life.
The main goal of this research is to see if BLU-5937 can reduce how often people cough over a 12-week period. To make sure the results are reliable, some participants will receive the new medicine, while others will be given a 'dummy pill' (placebo) that looks the same but contains no active ingredients. Neither you nor your study doctor will know which one you are taking; this is a common and important step in medical research to get the clearest possible answers.
Over 52 weeks, the study team will carefully monitor participants to understand how well BLU-5937 works and if it has any side effects. This thorough approach helps us determine if this new medication could be a safe and effective option for those struggling with this challenging type of cough.
Key takeaways
- This study is for adults with difficult, long-term coughs.
- It's testing a new medicine called BLU-5937.
- You might receive the medicine or a dummy pill.
- The study lasts for about a year (52 weeks).
- Your health and cough frequency will be closely monitored.
- You can stop participating at any time.
Who may be eligible?
This study is looking for adults between 18 and 80 years old who have had a persistent, stubborn cough for at least a year that hasn't gotten better with other treatments. If you are a woman who can become pregnant, you'll need to use very effective birth control during and shortly after the study.
However, there are some reasons why you might not be able to join. For example, if you currently smoke or vape (or have recently quit), or have a history of heavy smoking, this study might not be suitable for you. We also can't include people with certain lung conditions like severe asthma or long-term bronchitis, or if you've recently had a chest infection.
Other reasons you might not be eligible include a recent cancer diagnosis, a history of drug or alcohol misuse, or certain blood infections like HIV or hepatitis. We also can't include anyone who has previously taken part in a study for this specific medicine, BLU-5937.
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 persistent cough for at least a year that hasn't improved with other treatments?
- Are you not currently smoking or vaping?
- Do you not have certain serious lung conditions (like severe COPD or uncontrolled asthma)?
- Have you been free from cancer for the last 5 years?
- If you are a woman who can become pregnant, are you willing to use effective birth control during the study?
What does participation involve?
If you decide to take part in this study, you'll be involved for about 52 weeks. Over this time, you'll have regular visits to the study clinic where the team will monitor your health and how the treatment is affecting your cough. You'll be given either the new medicine, BLU-5937, or a dummy pill to take, as assigned by chance. The team will carefully explain how and when to take your study medication.
During your visits, assessments will likely include checking your cough frequency, which might involve using a special device or keeping a diary, physical examinations, and possibly blood tests or other evaluations to check your health and safety. There will be initial screening appointments to confirm you meet the study requirements, and follow-up visits throughout the 52 weeks to track your progress and any changes. Everything will be explained in detail before you decide to join.
Potential risks and benefits
Locations (191)
- GSK Investigational SiteVerified postcodeLitchfield Park, United States
- GSK Investigational SiteVerified postcodeScottsdale, United States
- GSK Investigational SiteVerified postcodeEncinitas, United States
- GSK Investigational SiteVerified postcodeMission Viejo, United States
- GSK Investigational SiteVerified postcodeParamount, United States
- GSK Investigational SiteVerified postcodeRoseville, United States
- GSK Investigational SiteVerified postcodeAurora, United States
- GSK Investigational SiteVerified postcodeColorado Springs, United States
- GSK Investigational SiteVerified postcodeClearwater, United States
- GSK Investigational SiteVerified postcodeGainesville, United States
- GSK Investigational SiteVerified postcodeMiami, United States
- GSK Investigational SiteVerified postcodeMiami, United States
Common questions
What is 'refractory chronic cough'?
It's a persistent cough that has lasted for longer than 8 weeks and hasn't responded to usual treatments.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredients. It helps us compare the real medicine's effects.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know whether you are receiving BLU-5937 or the placebo. This helps ensure fair results.
How long will I be in the study?
The study will last for a total of 52 weeks from when you start.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and it won't affect any future medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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