A Study to Investigate the Efficacy and Safety of SC0032, a Magnesium Salt Oral Spray, in Adults With Refractory or Unexplained Chronic Cough
This study is testing a new oral spray called SC0032, which contains a magnesium salt. It's for adults aged 18 to 80 who have a chronic cough. This means a cough that has lasted for a long time (at least 6 months) and either hasn't improved with other treatments (refractory) or for which doctors haven't found a clear cause (unexplained). The main goal is to find out if SC0032 is safe and if it helps reduce coughing. Some participants will receive the active spray, while others will get a placebo (a dummy spray with no active ingredients) to compare the effects. The study involves several stages, including treatment periods and follow-up, and will check how often people cough and how severe their cough feels.
At a glance
What is this study about?
This research is looking into a new oral spray called SC0032. It's a special type of magnesium salt designed to help people who have had a cough for a very long time – at least six months. This kind of cough is often called a 'chronic cough.' Some people have chronic coughs that don't get better with usual medicines, which doctors call 'refractory.' Others have a chronic cough where doctors can't find a clear reason for it, known as an 'unexplained' chronic cough.
The study aims to see two main things about the SC0032 spray: first, if it's safe for people to use, and second, if it actually helps to reduce the coughing spells. To do this, some people will get the active SC0032 spray, and others will get a placebo. A placebo looks exactly like the real spray but has no active ingredients. This helps researchers compare the effects accurately, so they can be sure any improvements are due to the treatment and not just other factors.
Finding new ways to manage chronic cough is important because it can significantly impact daily life, sleep, and overall well-being. If SC0032 proves to be safe and effective, it could offer a new option for people who are currently struggling with persistent coughs that haven't responded to existing treatments.
Key takeaways
- Tests a new magnesium oral spray (SC0032) for stubborn chronic cough.
- Compares the spray to a placebo (dummy spray) to see if it works.
- Aims to check both safety and effectiveness in reducing coughs.
- Participation involves treatment periods, follow-up, and about four visits.
- Designed for adults aged 18-80 with long-lasting coughs.
- You can stop participating at any time.
Who may be eligible?
This study is for adults generally aged between 18 and 80 years old, who have been diagnosed with a chronic cough for at least six months. This means a cough that has either not responded to other treatments or for which no clear cause has been found. To qualify, you must be coughing quite frequently, typically at least 8 times an hour over a full day, and your cough should feel noticeable or bothersome.
There are also some important things that would prevent you from taking part. For example, if you've smoked or vaped recently (within the last six months), or have a long history of heavy smoking, you wouldn't be able to join. You also can't have certain serious lung conditions like severe asthma or COPD, or a recent chest infection. If you've had cancer in the last five years (unless it was a minor skin cancer) or certain types of liver infections, you would also be excluded. Additionally, if you're taking specific medications like strong painkillers (opioids), certain heart medicines (ACE inhibitors), or cough suppressants, you might not be eligible.
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 hasn't gone away for at least 6 months, and either other treatments haven't helped, or doctors can't find a clear cause?
- Do you currently cough quite often (e.g., several times an hour)?
- Have you not smoked, vaped, or stopped using other inhaled substances (like cannabis) in the last 6 months?
- Do you not have serious lung conditions like severe COPD or uncontrolled asthma?
- Are you able to use effective contraception if you are a woman who could become pregnant or a man whose partner could become pregnant?
What does participation involve?
Taking part in this study involves several stages over a few months. Initially, there's an optional stage where you might help check how easy the spray device is to use, which doesn't add extra visits. The first main part lasts two weeks, where you'll get used to the study routine. This is followed by a three-week treatment period where you'll use either the active spray or the placebo. Finally, there's a four-week follow-up period after your treatment ends, where you won't be taking the spray.
Throughout the study, you would attend four main visits. You’ll be asked to keep track of your cough, possibly using a special monitor and a phone app. If you don't meet the requirements to continue after the first two weeks, your participation would be shorter, involving only two visits, and you wouldn't receive the active treatment. If you decide to stop participating at any point, you'll be asked to attend one final visit.
Potential risks and benefits
Locations (3)
- The Wellcome Trust-Wolfson Northern Ireland Clinical Research Facility U Floor, Belfast City HospitalVerified postcodeBelfast, United Kingdom
- Kings College HospitalVerified postcodeLondon, United Kingdom
- Royal Brompton HospitalVerified postcodeLondon, United Kingdom
Common questions
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real spray but contains no active medicine. It helps researchers see if the real spray genuinely works better than nothing.
How long will I need to be in the study?
If you complete all main parts, your active participation will last about nine weeks, with four study visits. There's also an optional early part that doesn't add extra visits.
Will I know if I'm getting the real spray or the placebo?
No, during the main treatment phase, neither you nor your study doctor will know whether you are receiving the active spray or the placebo. This helps keep the study fair and unbiased.
What if I decide I don't want to continue with the study?
You are free to leave the study at any time, for any reason, without providing an explanation. Your medical care will not be affected.
What if I have other health problems or take other medicines?
Certain health conditions or medications might prevent you from joining the study for safety reasons. This will be discussed with you during the screening process.
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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