Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
This study is comparing two types of asthma inhalers for people with mild to moderate asthma. One inhaler uses a new, more environmentally friendly gas (called a propellant) to deliver the medicine. The other uses the gas found in many current inhalers. We want to make sure the new inhaler works just as effectively and safely as the existing ones. The goal is to find out if this newer, 'green' option can help people manage their asthma just as well, without compromising their health or safety. This is an important step in developing new treatments that are also better for the environment.
At a glance
What is this study about?
This research study is about comparing different asthma inhalers. When you use an inhaler, the medicine is pushed out by a gas called a propellant. This study is looking at a new kind of propellant that is designed to be much better for the environment, as it has less of an impact on global warming compared to the propellants currently used in many inhalers.
The main aim is to see if an inhaler with this new, climate-friendly propellant works just as well, is as safe, and is as easy to use as inhalers with the older type of propellant. We want to be sure that people with mild to moderate asthma who might use this new inhaler will get the same effective treatment without any new or unexpected side effects.
This study will involve people across several countries, including the UK. By taking part, you would be helping researchers understand if this new, greener inhaler can be a good option for future asthma treatment, providing effective relief while also being mindful of our planet.
Key takeaways
- This study evaluates a new, greener asthma inhaler.
- It aims to ensure the new inhaler is as safe and effective as current options.
- Participation helps advance climate-friendly asthma treatments.
- Close medical monitoring is provided throughout the study.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old who has had asthma for at least six months and was diagnosed before turning 50. You should be a non-smoker or an ex-smoker, and your body weight should be within a certain range. Your asthma must also be stable and controlled or partly controlled, meaning you're already taking specific asthma medicines like inhaled steroids, possibly with a long-acting bronchodilator, and your symptoms are fairly well managed.
There are also some reasons why you might not be able to join. For example, if you've had a very severe asthma attack or needed emergency care for your asthma in the last six months, or if you've recently needed strong steroid medicines by mouth or injection for your asthma. You also can't take part if you have certain types of asthma, like only exercise-induced or seasonal asthma that doesn't need daily medicine, or if you're currently on high doses of certain asthma medications.
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 75 years old?
- Do you have mild to moderate asthma that is stable and fairly well-controlled?
- Are you a non-smoker or an ex-smoker?
- Have you *not* had a severe asthma attack or needed emergency asthma care in the last 6 months?
- Are you currently taking low or medium doses of inhaled asthma medicines?
- Have you *not* recently taken strong steroid medicines for your asthma?
What does participation involve?
If you take part in this study, you will be given one of the study inhalers to use. There will be several visits to the clinic where the research team will check your asthma, measure your lung function (like with a breathing test called FEV1), and ask about your symptoms and how you're feeling. They will also monitor for any side effects from the inhaler.
You'll need to follow specific instructions on how to use the study inhaler and report any changes in your asthma or general health. The research team will explain everything in detail, including how often you'll need to visit and for how long the study will last for each person. You may also need to stop using some of your regular asthma medicines for a short period before or during the study, but this will be carefully supervised.
Potential risks and benefits
Locations (1)
- Elpida Trials - Parloes HubVerified postcodeDagenham, United Kingdom· Recruiting
Common questions
What is a 'propellant' in an inhaler?
It's the gas that pushes the medicine out of your inhaler so you can breathe it in.
Why is a 'climate friendly' inhaler important?
It means the gas used in the inhaler is designed to have less impact on global warming, which is better for the environment.
Will I know which type of inhaler I'm getting?
Often in studies like this, participants don't know which specific inhaler they are receiving to ensure fair results. This is called 'blinding'.
What does 'mild to moderate asthma' mean?
It refers to people whose asthma symptoms are not severe and are usually managed with regular, lower doses of asthma medicines.
What if my asthma gets worse during the study?
The study team will monitor your asthma closely. If it gets worse, they will provide appropriate care and may stop your participation if needed for your safety.
How to find out more
Chiesi Clinical Trial Info Chiesi Clinical Trials
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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