Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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 looking at a new medicine called CHF 1535, which is being developed to help people with asthma. We want to understand how the body handles this medicine when it's breathed in using an inhaler. Specifically, we'll compare two different versions of the inhaler and see if using a special device called an AeroChamber Plus® spacer makes a difference to how much medicine gets into the blood. We will also be carefully checking for any side effects to make sure the medicine is safe. This is an early-stage study involving healthy adult volunteers, not people with asthma, to safely learn more about the medicine before testing it in patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

Start

14 Aug 2024

Asthma

What is this study about?

This study is an early step in developing a new medicine, called CHF 1535, for people who have asthma. When new medicines are created, scientists need to find the best way to deliver them and make sure they are safe. This particular study focuses on an inhaler medicine, similar to those many people with asthma already use.

The main goal is to compare two slightly different versions of the inhaler medicine to see how much of the active drug gets into the bloodstream. It also checks if using an "AeroChamber Plus® spacer" – a device that helps deliver the medicine from the inhaler more effectively – changes anything. By understanding these things, researchers can choose the best way to give the medicine to patients in the future.

This study is also very important for checking safety. Even though participants are healthy and don't have asthma, every new medicine needs to be carefully monitored for any unwanted effects. The information gathered here will help make sure that when the medicine eventually gets tested in people with asthma, it's as safe as possible.

Key takeaways

This study is testing a new asthma medicine (CHF 1535) in healthy adults.
It aims to understand how the medicine works in the body and check its safety.
Researchers will compare different ways of taking the medicine, including with a spacer.
Participation involves clinic visits, taking medicine by inhaler, and blood tests.
This is an early-stage study (Phase I) to gain important information before testing in asthma patients.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adult volunteers to take part. This means you should generally be in good health and not have any serious medical conditions.

You need to be at least 18 years old to join this study. There is no upper age limit, as long as you meet all the other health requirements.

Both men and women are welcome to participate. Specific details about your health and medical history would be discussed by the study team to see if you are a good fit.

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?
Are you generally in good health?
Do you not have asthma?
Are you able to attend several clinic appointments?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you would visit the study clinic several times. During these visits, you would receive the study medicine through an inhaler. Sometimes you would use the inhaler on its own, and sometimes you would use it with a spacer device. The team would take blood samples at different times after you've taken the medicine to measure its levels. You would also have regular health checks, like blood pressure and heart rate measurements, to make sure you're doing well and to check for any side effects. The total duration of your involvement in the study, including all visits and follow-up, would be fully explained to you before you decide to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this early-stage study, volunteers are unlikely to directly benefit from the new medicine as it's primarily designed for people with asthma. However, you would be helping advance medical knowledge and contribute to finding new treatments. Potential risks might include discomfort from blood draws, temporary side effects from the study medicine (which would be fully explained), or the time commitment. You would receive detailed information about all potential side effects before deciding to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is a 'spacer' and why is it used?

A spacer is a clear plastic tube that attaches to an inhaler. It helps make sure more of the medicine gets into your lungs, rather than settling in your mouth or throat, making the inhaler work better.

Why are healthy people taking part, not people with asthma?

In early studies like this, healthy volunteers help us safely learn how the body handles a new medicine and check for common side effects, before it’s given to people who are unwell.

Will I get paid for taking part?

Information about payment for travel or time spent in the study would be discussed and explained in full detail by the study team.

What is 'Phase I' of a clinical trial?

Phase I is the first step where a new medicine is tested in humans, usually in a small number of healthy volunteers. The main goals are to check for safety, and to learn how the medicine behaves in the body.

What if I feel unwell during the study?

The study team will closely monitor your health throughout. If you feel unwell at any point, you should tell the study staff immediately, and they will provide care and guidance.