Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Not applicable

This is an early-stage research study, often called a Phase 1 trial. We are looking for healthy adults and people who have a lung condition called bronchiectasis, but not the type linked to cystic fibrosis. The main aim is to understand how a new potential treatment behaves in the human body. This includes seeing how well it's absorbed, how it's processed, and how it leaves the body. Researchers also want to check for its safety. By joining, you could help scientists learn more about this condition and contribute to the development of new treatments that might help people in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

Start

15 Jan 2025

Non-cystic fibrosis bronchiectasis

What is this study about?

This research is an early step in testing a new treatment. It's often called a 'Phase 1 human pharmacology study'. What that means is the doctors and scientists want to carefully see how a new medicine or treatment works inside the human body. They'll be looking at things like how much of the treatment gets into your system, how long it stays there, and how your body gets rid of it. This helps them understand the best way to give the treatment if it goes on to be studied more.

The study involves two groups of people: healthy volunteers and people who have non-cystic fibrosis bronchiectasis. Bronchiectasis is a long-term lung condition where your airways become abnormally widened, which can lead to infections and breathing difficulties. It's important to test the treatment in both healthy people and those with the condition to see if there are any differences.

The main goal is to check that the new treatment is safe and to get a good idea of how it acts in the body. This kind of early study is crucial because the information gathered helps decide if the treatment is promising enough to be tested in larger studies later on. Your participation could provide valuable information that helps improve health for people living with bronchiectasis in the future.

Key takeaways

This is an early-stage study (Phase 1) looking at a new treatment for non-cystic fibrosis bronchiectasis.
The main goals are to understand how the treatment works in the body and to check its safety.
It needs healthy adults and adults with non-cystic fibrosis bronchiectasis.
Participation involves clinic visits, health checks, and receiving the study treatment.
You'll be closely monitored, and your contribution could help future patients.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit. Both men and women can join.

The study is looking for two groups of people: healthy volunteers and people who have already been diagnosed with a specific lung condition called non-cystic fibrosis bronchiectasis. This means your bronchiectasis is not caused by cystic fibrosis.

There will be other detailed checks to make sure the study is safe and right for you. For instance, the research team will ask about your health history and any medicines you are currently taking.

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 bronchiectasis that is NOT due to cystic fibrosis?
Are you generally healthy and able to attend clinic visits?
Are you comfortable with regular health checks, including blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would likely have several visits to the study clinic. These visits might include health checks, blood tests, and other assessments to see how your body is responding to the treatment. You would receive the study treatment, which could be given in different ways, like a pill or injection, depending on what is being tested. Researchers will carefully collect information about your health and any effects you experience.

The specifics of your participation, such as the total number of visits, how long each visit lasts, and the overall duration of the study – from your first visit to your last follow-up – will be explained by the study team. Usually, early-stage studies like this involve close monitoring for a set period.

Potential risks and benefits

Taking part in any study has possible benefits and risks. A potential benefit is that you could be helping to advance medical science and contribute to finding new treatments for bronchiectasis, which might help others in the future. For yourself, you might receive additional health monitoring. Potential risks could include side effects from the experimental treatment, which will be carefully discussed with you by the study team. They will also explain any discomfort from tests or procedures. Remember, participating is always your choice, and 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
Belgium

Common questions

What is non-cystic fibrosis bronchiectasis?

It's a long-term lung condition where the airways in your lungs become abnormally wide, which can make you prone to infections and breathing problems. It's not the type of bronchiectasis caused by cystic fibrosis.

Why is this study called 'Phase 1'?

Phase 1 means it's one of the first times a new treatment is being tested in humans. The main goals are to check how safe it is and how it behaves in the body.

Will I definitely get the new treatment?

In some early studies, participants might receive the new treatment, while others might receive a placebo (a dummy treatment) or a standard treatment for comparison. The study team will tell you exactly what to expect for this particular study.

Will I have to spend time in a clinic?

Yes, it's very likely you will need to come to a study clinic for visits, medical checks, and to receive the treatment. The research team will give you all the details about the schedule.

Will I be paid for taking part?

Some studies offer payment for your time and travel, especially for early-stage trials. This will be discussed with you by the research team if you are suitable for the study.