Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A single-centre, single-dose, open label, non-randomized, parallel group, clinical pharmacology study of CHF 6001 in asthmatic adolescent patients and in asthmatic adult patients as control group

This study is looking at a new asthma medicine called CHF 6001, which is given through an inhaler. It's an early phase study, meaning researchers are mainly trying to understand how the medicine works in the body and if it's safe. They are giving a single dose to teenagers and adults who have asthma. The study wants to find out how much of the medicine gets into the blood and how long it stays there. They will also check if it affects things like heart rate or blood pressure. This research is important for finding new ways to help people manage their asthma.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

Start

23 Jan 2025

Asthma

What is this study about?

This study is about a new medicine for asthma, called CHF 6001. When you breathe in this medicine using a special inhaler, the researchers want to see what happens inside your body. They are particularly interested in how much of the medicine gets into your blood and how quickly your body uses or gets rid of it. This helps them understand if the medicine is reaching the right places and how often it might need to be taken in the future.

They will be giving a single dose of this new medicine to both teenagers and adults who have asthma. It's a phase II study, which means it's an early step in testing new medicines. At this stage, the main goal is to learn a lot about the medicine's properties and to make sure it's not causing any unexpected problems.

By gathering this information, scientists can decide if CHF 6001 is promising enough to test further in larger studies. The aim is always to find better and safer treatments for people living with asthma.

Key takeaways

This study is testing a new asthma medicine delivered by inhaler.
It's an early-stage study to understand how the medicine works in the body.
Participants will receive a single dose of the medicine.
Researchers will check how the medicine behaves and if it causes side effects.
The study includes adults and teenagers aged 18 and older with asthma.
Your safety will be carefully monitored throughout the study.

Who may be eligible?

To join this study, you need to be an adult or a teenager aged 18 years or older. This study is open to everyone, regardless of whether you are male or female.

Specifically, you must have been diagnosed with asthma. If you fit these basic requirements, the research team will do further checks to make sure the study is right for you and that taking part would be safe.

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 have a diagnosis of asthma?
Are you able to attend all study visits?
Are you willing to take a single dose of a new medicine?
Are you comfortable with blood tests and heart checks (ECGs)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a single dose of the new asthma medicine, CHF 6001, through an inhaler. Throughout your participation, doctors and nurses will closely monitor your health. They will take blood samples to measure how much of the medicine is in your body and how long it stays there. They will also check your heart with an ECG (a simple test to look at your heart's electrical activity) and measure your blood pressure at different times.

Your safety is a top priority, so the research team will regularly ask you if you're experiencing any side effects or unusual feelings. This study involves several visits over a period, starting with an initial check-up (screening) and continuing for a set amount of time after taking the medicine, including a final follow-up visit.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, potential benefits include contributing to medical research that could lead to new asthma treatments and receiving close medical monitoring. However, as this is a new medicine, there's a chance you might experience side effects that aren't fully known yet. Researchers will be carefully looking for any problems, such as changes in heart rate or blood pressure. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Bulgaria

Common questions

What is CHF 6001?

CHF 6001 is a new medicine being developed for people with asthma, which you take by inhaling it.

Why are teenagers included?

The study includes people aged 18 and over to see how the medicine works in both younger adults and older adults with asthma.

What does a 'single dose' mean?

It means you will only take the new medicine once during the study, rather than over many days or weeks.

Will I know if I'm getting the real medicine?

Yes, in this study, everyone who takes part will receive the actual medicine, CHF 6001. There is no 'dummy' medicine (placebo).

How long will the study physically last for me?

The study involves several visits, from your initial checks to a follow-up appointment after taking the medicine. The research team will give you a clear timeline.