Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of Atuliflapon Given Orally Once Daily for Twelve Weeks in Adults with Moderate to Severe Uncontrolled Asthma

This research study is investigating a new oral medicine called Atuliflapon for adults living with moderate-to-severe asthma that isn't fully controlled. For 12 weeks, some participants will take Atuliflapon, while others will receive a dummy pill (placebo). Everyone will also continue to use their salbutamol inhaler as needed. The main goal is to find out if Atuliflapon can reduce the number of serious asthma flare-ups or worsening of symptoms. We'll also check how it affects breathing, asthma control, and quality of life. The study design is 'double-blind,' meaning neither you nor your study doctor will know if you're taking the new medicine or the placebo, to ensure fair results. Safety is very important, and we'll closely monitor for any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

AstraZeneca AB

Enrolment target

431

Start

16 Jul 2024

Moderate-to-Severe Uncontrolled Asthma

What is this study about?

Imagine your asthma still causes frequent problems, even with your usual medicines. This study is for adults whose asthma is moderate to severe and isn't fully under control. Researchers are testing a new medicine called Atuliflapon, which you would take as a pill by mouth once a day.

The main aim of this study is to see if Atuliflapon can prevent or reduce asthma flare-ups (also called exacerbations) and other serious asthma events. We'll also be looking at how well it helps your breathing, controls your asthma symptoms (like wheezing, coughing, or breathlessness), and improves your overall quality of life. Participants will be divided into groups, with some receiving Atuliflapon and others getting a 'placebo' – a pill that looks the same but contains no active medicine. This allows us to fairly compare the effects of the new drug.

This study is important because it could lead to new treatment options for people with asthma that's hard to manage. By taking part, you could contribute to medical knowledge that helps countless others with asthma in the future.

Key takeaways

This study tests a new oral medicine (Atuliflapon) for moderate-to-severe uncontrolled asthma.
It aims to see if Atuliflapon reduces asthma flare-ups and improves breathing.
Participants will take either Atuliflapon or a placebo for 12 weeks.
You'll continue using your salbutamol inhaler for quick relief.
The study is 'double-blind' for fair results.
Your health and safety will be closely monitored throughout.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. We welcome both men and women to participate.

The main requirement is that you have moderate-to-severe asthma that is not currently well controlled, despite the treatments you are already using. Your study doctor will check your medical history and conduct some tests to make sure you meet all the specific health requirements for the study.

There might be other reasons why you wouldn't be able to join, such as other medical conditions or medicines you are taking. All these details will be thoroughly checked by the study team during a screening visit.

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 moderate-to-severe asthma that isn't well controlled?
Are you able to take medicine by mouth once a day?
Are you willing to attend regular clinic visits for about 12 weeks?
Are you able to use a salbutamol inhaler if needed?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be involved for about 12 weeks, plus initial screening and a follow-up. You'll likely have several visits to the clinic for check-ups and tests. During these visits, the study team will measure your breathing, ask you about your asthma symptoms, and take blood samples. You'll receive either the study medicine (Atuliflapon) or a placebo, which you'll take once a day by mouth. You'll also continue to use your salbutamol inhaler as needed for quick relief. We'll monitor any side effects you might experience and keep track of your overall health throughout the study.

Potential risks and benefits

By taking part, you might benefit from closer medical attention for your asthma and potentially experience improved asthma control if you receive the active study drug. However, there's a chance you might experience side effects from the new medicine, or you might receive a placebo and not get any direct treatment benefit. There are also potential risks from blood tests or other procedures, though these are usually minor. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

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Unverified
Poland
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Unverified
Croatia
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Unverified
Bulgaria
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Unverified
Hungary
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Unverified
Germany
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Unverified
Netherlands
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Unverified
Slovenia
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Unverified
Spain
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Unverified
Romania
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Unverified
Slovakia

Common questions

What is a 'double-blind' study?

It means neither you nor your study doctor will know if you're getting the new medicine or a dummy pill. This helps us ensure the results are fair and unbiased.

What is a 'placebo'?

A placebo is a pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real effects of the new medicine.

Will I still use my regular asthma medicine?

You will continue to use your salbutamol reliever inhaler as needed, but other specific asthma medicines might be adjusted as part of the study plan. Your study doctor will explain this clearly.

How long will I be in the study?

The main treatment period is 12 weeks, but with screening and follow-up, your total involvement will be a bit longer. Your study team will give you a detailed timeline.

What are asthma 'flare-ups'?

Asthma flare-ups, or exacerbations, are times when your asthma symptoms get much worse, often needing extra medicine, a doctor's visit, or even hospitalisation.