Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

A Double Blind, Multicentre, Randomised Three-Period, Three-Treatment, Cross-Over Study To Evaluate The Effect of BGF MDI, BFF MDI and Placebo MDI on Exercise Parameters In Participants with Chronic Obstructive Pulmonary Disease (ATHLOS)

This research study, called ATHLOS, is for people living with a lung condition known as Chronic Obstructive Pulmonary Disease (COPD). The main goal is to find out if a new inhaler treatment, Trixeo Aerosphere, can help people with COPD exercise more easily. We’ll also be looking at how it compares to another inhaler and a 'dummy' inhaler (a placebo). Participants will try each of these treatments over time. Doctors will measure how much air people can breathe in and how far they can cycle before getting tired. They will also check if people feel less breathless and look at general lung function and any side effects. This helps us understand if the new inhaler is a helpful and safe treatment option for COPD.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

AstraZeneca AB

Enrolment target

160

Start

18 Sep 2023

Chronic Obstructive Pulmonary Disease

What is this study about?

This research is all about helping people with Chronic Obstructive Pulmonary Disease (COPD) manage their condition better. COPD is a common lung disease that makes it hard to breathe, often causing breathlessness, coughing, and wheezing. This can make everyday activities, like walking or exercising, quite difficult.

The study aims to see if a new inhaler medication, Trixeo Aerosphere, can improve how well people with COPD can exercise. To do this, we're comparing it to another type of inhaler and also to a 'dummy' inhaler, which contains no active medicine. By doing this comparison, we can clearly see if the new inhaler makes a real difference in how much air people can take into their lungs and how long they can cycle without getting too tired.

Taking part in this study would help doctors understand if Trixeo Aerosphere could be a valuable new treatment option. If successful, it could mean that people with COPD might find it easier to breathe and have more energy for their daily lives. Your participation is an important step in improving care for those with COPD.

Key takeaways

This study evaluates a new inhaler (Trixeo Aerosphere) for COPD.
It aims to see if the new inhaler helps people exercise more easily.
You would try three different inhalers: two active ones and a 'dummy' inhaler.
The study measures lung function, exercise ability, and breathlessness.
Both men and women aged 18 and over with COPD can inquire about joining.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD). There's no upper age limit, so people of all adult ages are welcome to inquire. Both men and women are invited to take part.

To make sure the study results are clear and accurate, there will be certain health conditions or medications that might mean you can't join. For example, if you have other serious health problems that might affect the results or stop you from safely taking the study medication, you might not be able to participate. The study team will discuss all of these details with you.

It’s important that your doctor agrees it’s safe and suitable for you to take part. The study team will go through a full health check and ask about your medical history to confirm if you are suitable.

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?
Have you been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)?
Are you able to attend regular clinic visits?
Are you willing to try different inhaler treatments?
Are you generally able to do some exercise (like cycling)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be trying out three different treatments over time: the new Trixeo Aerosphere inhaler, another active inhaler, and a 'dummy' inhaler with no medicine. You won't know which one you are taking at any given time, nor will the study doctors – this is called 'double-blind' and helps keep the results fair.

Throughout the study, you'll have regular visits to the clinic. During these visits, the study team will carry out various tests. These include measurements of how much air you can breathe into your lungs (called 'inspiratory capacity'), how long you can cycle on a stationary bike before getting tired, and how breathless you feel during exercise. They will also check your general lung function and take your vital signs like blood pressure.

Each treatment period will be followed by a 'washout' period where you don't take the study medication. The study will involve several visits over a period of time, and the team will monitor any side effects you might experience. They will also follow up with you after your last dose to ensure your well-being.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving close medical attention and access to a new treatment that might improve your COPD symptoms. However, there are also potential risks; you might experience side effects from the study medications, or the treatment might not be effective for you. Some tests in the study, like exercise tests, might cause temporary discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
Spain

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, usually due to long-term exposure to harmful gases or particles, most often from smoking.

What do 'Phase III and Phase IV' mean?

Phase III means the treatment is being tested on a larger group of people to confirm its effectiveness and safety. Phase IV means the treatment is already approved but being studied further over a longer time or in specific groups to gather more information.

What is a 'dummy inhaler' (placebo)?

A dummy inhaler looks exactly like the real inhalers but contains no active medicine. It helps researchers understand if the new drug truly works better than no treatment at all, or if improvements are due to other factors.

Will I know if I'm getting the new treatment?

No, this is a 'double-blind' study. Neither you nor the study doctors will know which treatment you are receiving at any time. This helps ensure the results are unbiased and accurate.

How long will I be in the study?

The study involves three separate treatment periods, each followed by a break. The study team will give you a clear timeline of how long your total participation will be, including all visits and follow-ups.