Evaluation of the CHF 5993 concentration in blood, after inhalation with two different devices, (NEXThaler® versus pMDI), with and without Aerochamber spacer device, in healthy volunteers.
This research study is for healthy adult volunteers and aims to understand how a specific asthma medicine, called CHF 5993, gets into the bloodstream. Researchers want to compare two common ways of taking this medicine: using a NEXThaler inhaler and using a pMDI (often called a 'puffer' or metered-dose inhaler). They will also look at whether using a spacer device, which helps deliver the medicine to the lungs more effectively, makes a difference with either inhaler. The main goal is to see which combination of inhaler and spacer, if any, helps the medicine get into the body best. This kind of early study helps make sure medicines are used in the safest and most effective way for people with asthma in the future.
At a glance
What is this study about?
Imagine you have asthma and your doctor prescribes an inhaler to help you breathe easier. This study is all about making sure that the medicine from those inhalers gets to where it needs to be in your body. Specifically, researchers are looking at a medicine called CHF 5993, which is used for asthma. They want to understand how much of this medicine actually gets into your blood when you use it through different types of inhalers.
Think of it like this: Sometimes you drink water directly from a cup, and sometimes you use a straw. Both get water to you, but the way it's delivered is a bit different. In this study, they're comparing two main types of inhalers – one called NEXThaler and another called a pMDI (often known as a 'puffer'). They're also adding a 'spacer' device into the mix. A spacer is a clear chamber that attaches to your inhaler and helps make sure more of the medicine reaches your lungs, rather than settling in your mouth or throat. By comparing these different combinations, the researchers hope to learn the most effective way for people to take this asthma medicine.
This is an early-stage study, sometimes called a 'Phase I' study. This means it's one of the first times researchers are testing these specific ways of delivering the medicine in healthy people. The information gathered from this study will help doctors and scientists make better decisions about how to recommend asthma medications in the future, ultimately aiming to improve treatment for people living with asthma.
Key takeaways
- The study helps understand how an asthma medicine gets into the blood.
- It compares two common types of inhalers: NEXThaler and pMDI (puffer).
- It also checks if using a 'spacer' device makes a difference.
- Participants must be healthy adults, aged 18 or over.
- This research aims to improve future asthma treatments.
- Your involvement helps medical science advance.
Who may be eligible?
To join this study, people need to be at least 18 years old. There's no upper age limit, so adults of all ages can be considered.
Importantly, this study is looking for healthy volunteers. This means you should not have any major ongoing health problems, especially not asthma or other breathing difficulties. The aim is to see how the medicine works in a 'normal' body environment before testing it in people who actually have the condition.
Anyone who fits these general descriptions, regardless of their gender, can potentially take part. Deeper checks will be done by the study team to make sure it's safe for you to join.
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?
- Do you consider yourself generally healthy?
- Do you NOT have asthma or any other significant breathing problems?
- Are you comfortable having regular blood samples taken?
- Are you able to commit to several study visits?
What does participation involve?
This study involves a few visits to a clinic. During these visits, you will breathe in the study medicine using different inhalers, sometimes with a spacer and sometimes without. You will have blood samples taken regularly after each inhalation to measure how much of the medicine gets into your blood. Researchers will also monitor your general health.
The total amount of time you will spend participating in the study will be described in detail by the study team. Usually, early-stage studies like this involve completing all visits within a relatively short period, often over a few days or weeks, but with follow-up appointments.
Potential risks and benefits
Locations (1)
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Common questions
What is CHF 5993?
CHF 5993 is a specific asthma medicine that researchers are studying to understand how it's absorbed into the body.
What is a 'spacer' device?
A spacer is a plastic chamber that can be attached to some inhalers. It helps more of the medicine get into your lungs instead of staying in your mouth or throat.
Why are you looking for healthy volunteers?
Because this is an early-stage study, researchers first want to see how the medicine behaves in people without asthma or other health conditions. This helps them understand the medicine better before testing it in patients who have the illness.
Will I get paid for taking part?
This information is not provided in the brief details, but compensation for your time and travel is common in healthy volunteer studies. The study team will explain any payment details.
How long will I need to be involved?
The full duration isn't specified, but the study team will provide a schedule of all visits and how long each will take, including any follow-up appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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