A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
This research study is checking the safety of a new ingredient used in asthma inhalers. This ingredient is called a 'propellant', which is a gas that helps push the asthma medicine out of the inhaler so you can breathe it in. The study compares a new propellant, called HFA-152a, with one that's already commonly used in inhalers, called HFA-134a. Both propellants are types of Hydrofluoroalkane. For about 4 weeks, people with asthma will use an inhaler with one of these propellants. The main goal is to see if the new propellant is just as safe as the old one, helping to make sure future asthma treatments are effective and well-tolerated. This is a Phase 3 study, meaning it's one of the final steps before a new treatment can become widely available.
At a glance
What is this study about?
When you use an asthma inhaler, it contains the medicine you need, but also a special gas called a 'propellant'. This propellant is what makes the medicine spray out of the inhaler so you can breathe it in. Think of it like the air in an aerosol can that pushes the product out – but for medicine!
This study is focusing on these propellants, specifically looking at a new one called HFA-152a and comparing it to one that's already been used safely for a long time, called HFA-134a. The main aim is to check if the new propellant is just as safe for people with asthma over a short period of about four weeks. This is really important because ensuring the safety of all ingredients in medicines helps doctors and patients feel confident about new treatments.
By taking part, you would help researchers understand more about these propellants. This information could help develop new inhalers that are both effective for managing asthma and safe to use, contributing to better asthma care for everyone in the future.
Key takeaways
- This study checks the safety of a new inhaler 'propellant' (gas).
- It compares a new propellant with one already commonly used.
- Participation involves using a study inhaler for about 4 weeks.
- The study helps develop safer asthma treatments for the future.
- You must be 18+ with stable asthma to be considered.
Who may be eligible?
To join this study, you need to be at least 18 years old.
You should have been diagnosed with asthma for at least 6 months and your asthma should be stable, meaning no serious flare-ups in the last three months. Also, you should be managing your asthma with regular treatment, which could be an inhaler used when needed, or daily preventer inhalers, or even more advanced treatments. If you use a special device to measure your breathing, your result (called FEV1) should be at least 50% of what's expected for someone your age and height. Your asthma control, measured by a short questionnaire (ACQ-6), should also be good (score less than 1.5).
It's important that you haven't smoked or used any vaping products in the last year, and your total smoking history isn't more than 10 'pack-years' (a way to measure how much someone has smoked over their lifetime). Also, using marijuana even with a prescription would mean you can't join this study.
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 18 years old or older?
- Have you had asthma for at least 6 months?
- Is your asthma generally stable, with no serious flare-ups recently?
- Do you not smoke or vape, and haven't for the last year?
- Do you manage your asthma with regular treatments (e.g., inhalers)?
- Is your breathing (FEV1) at least 50% of what's expected for you?
What does participation involve?
If you decide to take part, you'll be given an asthma inhaler containing either the new propellant (HFA-152a) or the standard one (HFA-134a). You'll use this inhaler as part of your usual asthma treatment for about four weeks. The study will involve regular check-ups with the research team. These appointments will likely include discussions about how you're feeling, checking your breathing, and possibly some blood or urine tests to monitor your health and safety. You might also be asked to complete questionnaires about your asthma symptoms. After the four-week period, there will be a final check-up to make sure everything is okay. The total time you'd be involved in the study, including all visits and follow-ups, would be relatively short, focusing mainly on that four-week treatment period.
Potential risks and benefits
Locations (18)
- GSK Investigational SiteVerified postcodeAventura, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeMiami, United States· Recruiting
- GSK Investigational SiteVerified postcodeNaples, United States· Recruiting
- GSK Investigational SiteVerified postcodeOwensboro, United States· Recruiting
- GSK Investigational SiteVerified postcodeColumbia, United States· Recruiting
- GSK Investigational SiteVerified postcodeHenderson, United States· Recruiting
- GSK Investigational SiteVerified postcodeMedford, United States· Recruiting
- GSK Investigational SiteVerified postcodeSpartanburg, United States· Recruiting
- GSK Investigational SiteVerified postcodeSpartanburg, United States· Recruiting
- GSK Investigational SiteVerified postcodeCypress, United States· Recruiting
- GSK Investigational SiteVerified postcodeTomball, United States· Recruiting
Common questions
What is a 'propellant' in an inhaler?
It's a harmless gas inside your inhaler that helps push the medicine out so you can breathe it in.
Will I know which propellant I'm getting?
Often in these types of studies, neither you nor the study team will know who gets which propellant until the study ends. This helps keep the results fair.
How long will I be in the study?
You'll be using the study inhaler for about 4 weeks, with a few visits before, during, and after this period.
Do I have to pay to join this study?
No, you will not have to pay to participate in the study. All study-related assessments and treatments will be provided at no cost to you.
Will this study affect my regular asthma care?
The study aims to add to your regular care, not replace it. Your usual doctor will still be involved in your overall asthma management.
How to find out more
US GSK Clinical Trials Call Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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