Comparison of the study drug CHF 1535 formulated with two different propellants to learn about drug levels in blood and safety after inhalation, with and without the use of the Aerochamber Plus® spacer, in healthy volunteers.
This study is focusing on a new medicine, CHF 1535, which is being developed for people with asthma and a lung condition called COPD. We're testing two slightly different versions of how the medicine is delivered when you breathe it in. The aim is to understand how much of the medicine gets into the body and to check for any side effects. We are also looking at whether using a special device called an Aerochamber Plus® spacer changes anything. Healthy adult volunteers are taking part in this early stage of research to make sure the medicine is safe and to gather important information before it's tested in people with asthma or COPD.
At a glance
What is this study about?
This research is looking at a new medicine called CHF 1535, which could potentially help people with breathing conditions like asthma and COPD. Asthma causes your airways to narrow and swell, making it hard to breathe, while COPD is a long-term lung disease that makes it difficult to get air in and out of your lungs.
In this early study, we're focusing on how different ways of preparing the inhaled medicine affect how it works. Specifically, we're comparing two slightly different types of inhalers that deliver CHF 1535. We want to find out if one type of inhaler delivers more medicine into the bloodstream than the other, and we're also checking how safe both versions are.
We're also investigating whether using a special device called a spacer (like the Aerochamber Plus®) changes how the medicine is delivered. Spacers can help more of the medicine reach your lungs. This information is really important because it helps scientists understand the best way to give this new medicine to patients in the future, making sure it's as effective and safe as possible.
Key takeaways
- Tests a new medicine, CHF 1535, for asthma and COPD.
- Compares two different ways the medicine is delivered by inhaler.
- Checks how much medicine gets into the body and if it's safe.
- Investigates using a 'spacer' device with the inhaler.
- Involves healthy adult volunteers only at this stage.
- Aims to gather important information for future patient treatments.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should generally be in good health and not have any serious ongoing medical conditions.
You need to be at least 18 years old to join this study. There is no upper age limit, so adults of all ages, as long as they are healthy, can be considered.
Both men and women are welcome to participate. Researchers want to understand how the medicine works in both sexes. Ultimately, the study team will check your health carefully to make sure it's safe for you to take part.
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 at least 18 years old?
- Do you consider yourself generally healthy?
- Are you able to attend clinic appointments as required?
- Are you able to use an inhaler and a spacer device?
- Are you willing to have blood tests?
- Are you a man or a woman?
What does participation involve?
If you take part in this study, you will be given the study drug CHF 1535 to inhale. This will be done using two different types of inhalers and sometimes also with a spacer device. You will attend several appointments at the study clinic where your health will be checked regularly. This will include blood tests to measure the levels of the drug in your body, and we will also be looking out for any side effects. The exact number of visits, how long each visit lasts, and the total time you would be involved in the study would be explained in detail by the study team. You would receive all necessary medication as part of the study.
Potential risks and benefits
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Common questions
What is CHF 1535?
CHF 1535 is a new medicine being developed that might help people with breathing problems like asthma and COPD. This study is an early step in understanding it better.
Why are you studying healthy people if the drug is for asthma and COPD?
In the very first stage of testing new medicines, researchers often start with healthy volunteers. This helps us ensure the medicine is safe and understand how the body handles it before giving it to people who are already unwell.
What is a 'spacer' and why is it used?
A spacer is a device used with an inhaler that helps more of the medicine get into your lungs. We're looking at whether using a spacer changes how CHF 1535 works.
Will I get paid to take part?
The information provided does not mention payment. Usually, details about compensation, if any, for time and travel would be discussed by the study team if you express interest.
How long will I need to be in the study?
The total duration of your involvement isn't specified here, but the study team will provide you with a detailed schedule including appointments and overall commitment if you look into joining.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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