AuthorisedTherapeutic confirmatory (Phase III)Interventional

A 52 week, randomized, double-blind, double dummy multinational, multicenter, active controlled, 2-arm parallel group trial comparing CHF 5993 100/6/12.5 µg pMDI (fixed combination of extrafine Beclomethasone Dipropionate plus Formoterol Fumarate plus Glycopyrronium Bromide) to Seretide® Evohaler® 125/25 µg pMDI (fixed combination of fluticasone propionate / salmeterol xinafoate) in adolescent subjects with asthma uncontrolled on medium doses of inhaled corticosteroids in combination with long acting ß2 agonists.

This research study is looking at a new inhaler for teenagers who have asthma that isn't fully controlled, even though they're already using an inhaler. The new inhaler, called CHF 5993, contains three different medicines designed to help open the airways and calm inflammation. We are comparing it to a widely used asthma inhaler called Seretide Evohaler. The main goal is to find out if CHF 5993 improves lung function and helps prevent asthma flare-ups more effectively over a year of treatment. Participants will be given either the new inhaler or Seretide, and neither they nor their doctors will know which one they are using until the study ends. This helps ensure fair results.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

147

Start

26 Sep 2025

Uncontrolled Asthma

What is this study about?

This clinical trial is designed to investigate a new inhaler called CHF 5993 for teenagers who are struggling with difficult-to-control asthma. Asthma is a common lung condition that can make it hard to breathe, and for some, even with their usual inhalers, their symptoms aren't fully managed. This new inhaler contains a combination of three medicines that work together to help open the airways and reduce inflammation in the lungs, making breathing easier.

We are comparing this new inhaler to a well-known and commonly prescribed asthma inhaler called Seretide Evohaler. Seretide also contains a combination of medicines that help manage asthma symptoms. By comparing these two treatments, researchers hope to determine if CHF 5993 is more effective at improving lung function, reducing asthma attacks, and generally improving the quality of life for young people living with asthma.

This is a 'Phase III' study, which means it's a large and important step in testing a new medicine. If the results are positive, it could mean a new treatment option for teenagers with asthma that is hard to control. The study will last for 52 weeks (about one year) and will involve many participants across different countries, helping to gather reliable information about how the new inhaler works.

Key takeaways

This study compares a new asthma inhaler (CHF 5993) to a standard one (Seretide).
It's for teenagers whose asthma isn't well controlled with their current treatment.
The main goal is to see if the new inhaler improves breathing and reduces asthma attacks.
The study lasts for about one year and involves regular check-ups.
Participants will not know which inhaler they are receiving during the study.
It aims to find new, effective treatments for difficult-to-control asthma.

Who may be eligible?

This study is looking for teenagers who have asthma. The most important thing is that their asthma is not fully under control, even though they are already using an inhaler that contains a 'preventer' steroid medicine combined with a 'long-acting' bronchodilator. This means they might still have symptoms like wheezing, coughing, or breathlessness fairly often.

There aren't strict age limits for this study, but it is specifically for adolescents. Both boys and girls can take part. The research team will review each person carefully to make sure they meet all the specific criteria needed for the study, which also include details about their general health and other medicines they might be 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 a teenager with asthma?
Do you still have asthma symptoms, even though you regularly use a 'preventer' inhaler (like a steroid combined with a long-acting bronchodilator)?
Are you willing to attend regular clinic visits for about a year?
Are you willing to use the study inhaler as instructed?
Are you generally healthy, apart from your asthma?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for a total of 52 weeks, which is about one year. During this time, you will be given either the new inhaler (CHF 5993) or the Seretide Evohaler, but neither you nor your doctor will know which one you are receiving. You will also receive a 'dummy' inhaler that looks the same but contains no active medicine, which is part of ensuring fair comparison.

You will need to attend several clinic visits throughout the year for check-ups and tests. These visits will involve measurements of your breathing using a machine called a spirometer, checking your vital signs like blood pressure and heart rate, and sometimes taking blood samples. You will also be asked to answer questionnaires about your asthma symptoms and how they affect your daily life.

The research team will closely monitor your health and any side effects you might experience. Regular follow-up ensures your safety and helps gather important information about how the study treatments are working.

Potential risks and benefits

Taking part in a study like this could offer some potential benefits, as you would receive close medical attention and a new potential treatment for your asthma. However, there's no guarantee that the study medicine will work for you, and it might not be better than your current treatment. As with any medicine, there's a chance of side effects, which the study team will monitor carefully. You are free to withdraw from 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
Italy
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Unverified
Germany
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Unverified
Spain

Common questions

What is the new inhaler, CHF 5993?

It's an experimental inhaler that contains three different medicines to help improve breathing and reduce asthma symptoms.

What is Seretide Evohaler?

It's a commonly used inhaler that combines two medicines to manage asthma, acting as a 'preventer'.

Will I know which inhaler I'm getting?

No, during the study, neither you nor your doctor will know if you're using the new inhaler or Seretide. This helps make the study fair.

How long will the study last?

The study will last for 52 weeks, which is about one year.

What does 'uncontrolled asthma' mean?

It means your asthma symptoms are still causing problems, even though you're using your regular asthma inhaler as prescribed.