Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial to learn how much budesonide, glycopyrronium, and formoterol fumarate (BGF) gets into and moves throughout the body when it is taken with hydrofluoroolefin (HFO) compared to when it is taken with hydrofluoroalkane (HFA) in healthy adults

This study is for healthy adults and is trying to understand how a medicine, known as BGF, behaves in the body when delivered by an inhaler. BGF is a combination of three medicines (budesonide, glycopyrronium, and formoterol fumarate) often used to treat breathing conditions. Researchers are comparing two different propellants, which are the substances that push the medicine out of the inhaler. One propellant is a newer type called HFO, and the other is a more common type called HFA. By studying healthy people, scientists can carefully check how much of the medicine gets into the bloodstream and how it moves around. This helps ensure future inhaler treatments are effective and safe for patients who need them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

11 Mar 2024

Not applicable healthy volunteers

What is this study about?

Imagine you use an inhaler to help you breathe. This study is all about understanding how a particular type of medicine, called BGF, gets from the inhaler into your body and moves around. BGF is actually a combination of three different medicines that often work together to help people with conditions like asthma or COPD (a lung disease).

When you use an inhaler, a special gas, called a 'propellant', pushes the medicine out so you can breathe it in. In this study, scientists are comparing two different propellants. One is a newer kind called HFO, and the other is a more commonly used kind called HFA. They want to see if the medicine behaves differently in the body depending on which propellant is used to deliver it.

This is a very early-stage study, sometimes called a 'Phase I' study, which means it's one of the first steps in testing a new treatment. Because it's focused on how the medicine moves through the body, it involves healthy adult volunteers. This allows researchers to observe the medicine's behaviour without other health conditions getting in the way. The information they gather will be crucial for developing better and safer inhalers for patients in the future.

Key takeaways

This study is testing different ways to deliver inhaler medicine.
It's for healthy adults aged 18 and over.
The goal is to understand how the medicine moves through the body.
Participation involves clinic visits and health checks.
You help advance medicine and may receive payment for your time.
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 ongoing medical conditions that might affect how the medicine works or how your body handles it.

You need to be at least 18 years old to join this study. There is no upper age limit, so adults of any age, as long as they are healthy, can be considered.

Both men and women are welcome to participate. The study aims to gather information that represents a broad range of people.

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 currently have any serious medical conditions?
Are you able to visit the clinic for appointments?
Are you comfortable taking new medication in an inhaler?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have several visits to a clinic over a period of time. These visits would involve taking the study medication (the inhaler) and undergoing various tests. These tests might include blood samples to measure how much of the medicine is in your body, and possibly other general health checks to make sure you remain well.

The researchers will closely monitor your health throughout the study. After the main part of the study, there might be follow-up calls or a final visit to ensure everything is okay. The total duration of your participation would be explained in detail before you agree to join, but studies like this often last for a few weeks.

Potential risks and benefits

Participating in a study like this helps advance medical science and could lead to better inhaler treatments for people in the future. As a healthy volunteer, you might not experience direct health benefits, but you would be compensated for your time. There are always potential risks with taking any medication, even in a study. These risks can include side effects, which the study staff will explain in detail. You have the right to withdraw from 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
Germany

Common questions

Why is this study only for healthy adults?

By studying healthy people, researchers can clearly see how the medicine works in the body without other health problems affecting the results.

What is BGF?

BGF is a combination of three medicines (budesonide, glycopyrronium, and formoterol fumarate) commonly used in inhalers for breathing conditions.

What is a propellant?

A propellant is the gas in an inhaler that pushes the medicine out so you can breathe it in.

Will I get paid to take part?

It's common for healthy volunteer studies to offer payment for your time and inconvenience. This will be openly discussed with you before you agree to participate.

What happens if I change my mind after joining?

You are free to leave the study at any point, for any reason, without it affecting your future medical care.