Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort® Turbuhaler® in Participants with Inadequately Controlled Asthma (VATHOS)

This study is for adults whose asthma isn't fully controlled by their current treatment. Researchers are comparing different inhaler medications, including new combinations of budesonide and formoterol, with existing treatments like Symbicort. The main aim is to see how well these new treatments improve lung function over 24 weeks. They also want to understand how quickly the medicines start working and if they help people use their rescue inhalers less often. Safety is also a key part of the study, monitoring any side effects. This research aims to find better ways to manage asthma and improve daily life for people living with the condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

160

Start

12 Jun 2024

Inadequately Controlled Asthma

What is this study about?

This research is looking for better ways to help adults whose asthma isn't fully under control. Even if you're using treatments, you might still have symptoms like wheezing, breathlessness, or coughing. This study aims to find out if certain inhaler medicines, specifically different versions of budesonide and formoterol, can improve breathing and reduce asthma symptoms more effectively than current treatments.

Researchers will compare a new combination inhaler with a common existing one (Symbicort Turbuhaler) and an inhaler that only contains budesonide. They want to see which treatment works best over 24 weeks by measuring how much air you can breathe out of your lungs (this is called FEV1). They'll also check how often you need to use a rescue inhaler, how quickly the medicine starts to work, and if it improves your quality of life.

Understanding how these different inhalers work can lead to better options for managing asthma. The goal is to help people breathe more easily, have fewer asthma attacks, and generally feel better, leading to an improved quality of life.

Key takeaways

Tests new inhaler treatments for adults with uncontrolled asthma.
Compares medicines to see which improves breathing and symptoms best.
Lasts about 24 weeks with regular clinic visits.
Monitors lung function, rescue inhaler use, and quality of life.
Aims to find better ways to manage asthma and improve daily living.

Who may be eligible?

This study is for adults aged 18 and over. Both men and women can take part.

You would be considered if your asthma isn't well controlled, meaning you might still experience symptoms even though you're on asthma medication.

There will be other specific health requirements that the study doctor will check to make sure the study is right for you and 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 asthma that isn't fully controlled by your current medicines?
Are you able to attend regular clinic visits for about 6 months?
Are you willing to use a study inhaler and keep a daily diary?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for about 24 weeks (around 6 months). You'll have several visits to the clinic where the study team will carry out health checks, take blood samples, and measure your breathing. You'll be given a study inhaler to use at home, but you won't know if it's the new treatment or a comparison medicine. You'll also be asked to keep a daily diary of your symptoms and how often you use your rescue inhaler. Training will be provided on how to use all devices. Regular follow-up will help the doctors understand how the treatment is working for you.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving close medical attention and potentially trying a new treatment that could improve your asthma symptoms. However, there are also potential risks, like experiencing side effects from the medication, even if they are mild. You might also find the clinic visits and tests inconvenient. It's important to remember that you can stop being part of the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
Italy
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Unverified
Germany

Common questions

What kind of asthma is this study for?

This study is for adults whose asthma is not well controlled, meaning you still have symptoms even while using your current asthma medicine.

Will I know what medicine I'm getting?

No, this is a 'double-blind' study, meaning neither you nor the study doctors will know which specific treatment you are receiving until after the study is complete. This helps make the study fair.

How long will I be in the study?

If you join, your participation will last for about 24 weeks, which is roughly six months.

What is FEV1?

FEV1 is a measurement of how much air you can forcefully breathe out of your lungs in one second. It's a common way to check how well your lungs are working.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your regular medical care.