Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Phase I, Randomized, Partial Double-blind, Single dose, 3-Way Cross-over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol for BGF MDI HFO Compared with BGF MDI HFA Using an AeroChamber Plus Flow-Vu Spacer and to Compare the Lung Exposure of BGF MDI HFO with a Spacer to BGF MDI HFO without a Spacer

This research is investigating a new type of inhaler that combines three medicines (Budesonide, Glycopyrronium, and Formoterol) often used for conditions like asthma or COPD. The main goal is to see how much of the medicine gets into the lungs when people use this new inhaler, especially comparing it with a spacer device versus without a spacer. We are also comparing it to a similar, existing inhaler. This is an early-stage study involving healthy adult volunteers. It helps scientists understand if the new inhaler delivers the medicine effectively and safely before it's tested in people with breathing conditions. Think of it as fine-tuning the way the medicine gets to where it needs to work.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

AstraZeneca AB

Enrolment target

132

Start

22 Apr 2024

Not applicable healthy volunteers

What is this study about?

This study is about a new inhaler that contains three different medicines (Budesonide, Glycopyrronium, and Formoterol). These medicines are commonly used to help people with lung conditions like asthma or chronic obstructive pulmonary disease (COPD) breathe more easily. The researchers want to understand how well the new inhaler delivers these medicines to the lungs.

Specifically, they're looking at two main things. Firstly, they want to compare this new inhaler with an existing one to see if they deliver a similar amount of medicine to the lungs. Secondly, they're interested in whether using a 'spacer' device with the new inhaler helps more medicine reach the lungs compared to using the inhaler on its own. A spacer is a large plastic tube that attaches to your inhaler and can make it easier to take your medicine correctly.

Because this is an early-stage study, it involves healthy adult volunteers. This helps the researchers focus on how the inhaler works in the body without other health conditions affecting the results. This kind of research is really important because it helps ensure that new medicines and inhaler devices are effective and deliver the right amount of medication to the right place.

Key takeaways

This study evaluates a new inhaler for lung conditions.
It aims to see how well medicine reaches the lungs with or without a spacer.
Healthy adults (18+) can participate, regardless of sex.
You would try different inhaler methods and be closely monitored.
Your involvement helps improve future lung treatments.
You can leave the study at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also take part.

This study is open to both men and women. The most important thing is that you are generally healthy, as the study is designed to understand how the new inhaler delivers medicine in healthy bodies, rather than testing it on people with existing health problems.

There might be other health checks or requirements that the study team will discuss with you to make sure it's safe for you to participate.

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?
Are you able to attend multiple study visits?
Are you comfortable giving blood samples?
Are you able to use an inhaler and a spacer device?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study inhalers in different ways. In a 'crossover' study like this, you would try using the new inhaler with a spacer, the new inhaler without a spacer, and also the comparison inhaler. Each of these would be given at separate times. This allows researchers to compare the different methods in the same person.

During your visits, you would have medical checks, give blood samples, and have specific tests to measure how much of the medicine reaches your lungs. You'll be asked to use the inhalers as directed by the study team. They will carefully monitor you after you take the medicine. There will also be follow-up appointments to ensure everything is okay. The study's total duration would involve several visits over a period of time, with breaks in between each different treatment part.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of taking part is contributing to medical science, helping to develop new and improved treatments for people with lung conditions. You will also receive careful medical monitoring throughout the study. Potential risks could include minor side effects from the study medication, though these are typically mild in early-stage studies and you will be closely watched. There might also be discomfort from blood samples or other assessments. 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
Germany

Common questions

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

A spacer is a large, clear tube you attach to your inhaler. It helps you breathe in the medicine more slowly and deeply, meaning more of it reaches your lungs where it's needed.

Will I get the actual medicine for breathing problems?

Yes, you will receive the active medications in the inhalers. This study is testing how well those medications are delivered to the lungs.

Why are healthy volunteers needed for this kind of study?

Using healthy volunteers helps researchers understand how the inhaler works and delivers medicine in a straightforward way, without other health conditions making the results complicated.

What does 'Phase I' mean for a study?

Phase I is an early stage of research, focusing on safety and how the medicine is processed by the body. It helps ensure a medicine is safe before being tested in larger groups of people.

Is this a new medicine not currently available?

The combination of medicines might be available in other forms, but this specific inhaler device and its delivery method are being assessed as a new potential option.