Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a Randomised, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients with Moderate to Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

This research study is looking at a new medication called AZD4604 for adults who have asthma that's still quite severe, even though they're already using common inhalers (ICS-LABA) at medium to high doses. For 12 weeks, some participants will receive the new medicine twice a day, while others will get a 'dummy' medicine (placebo) that looks the same but contains no active drug. This is so we can fairly compare how well AZD4604 works. We're mainly interested in seeing if it can help prevent asthma flare-ups and how long it takes for a flare-up to happen. We'll also check if it improves how well people can breathe and their asthma symptoms overall. The study aims to understand if AZD4604 is safe and effective for this group of people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Astrazeneca AB

Enrolment target

124

Start

07 Feb 2024

Adult Patients with Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

What is this study about?

This study is designed for adults who have asthma that is not fully under control, despite using their regular inhalers that combine two types of asthma medicines (ICS-LABA) at moderate to high doses. When asthma is not well controlled, it can lead to symptoms like wheezing, breathlessness, and even severe asthma attacks, which can be disruptive and frightening.

The main goal is to see if a new medicine, called AZD4604, can help these individuals. We want to find out if taking AZD4604 twice a day for 12 weeks can reduce the number of asthma flare-ups (also known as exacerbations). A flare-up is a period when asthma symptoms get worse and might need extra treatment. We'll be carefully tracking how long it takes for someone to have their first flare-up during the study.

Beyond preventing flare-ups, we'll also be looking at other important aspects of asthma control. This includes checking how people's breathing improves, how their asthma symptoms feel day and night, and how their quality of life is affected. This information will help us understand if AZD4604 could be a helpful new treatment option for people living with more severe asthma.

Key takeaways

Tests a new medicine, AZD4604, for adults with difficult-to-control asthma.
Compares AZD4604 to a dummy medicine (placebo) over 12 weeks.
Aims to reduce asthma flare-ups and improve breathing.
Participants will take the study medicine twice daily.
Involves regular clinic visits for health checks and symptom tracking.

Who may be eligible?

This study is looking for adults aged 18 or older. There is no upper age limit, meaning older adults are welcome to participate if they meet other criteria.

To be included, you must have moderate to severe asthma that is not well controlled, even though you are already using a combination inhaler prescribed at a medium to high dose. This means your asthma symptoms are still bothering you, or you've had asthma flare-ups despite your current treatment.

Both men and women can take part in this study. The research team will carefully check all potential participants to ensure the study is safe and appropriate for them.

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 is considered moderate to severe?
Is your asthma still not well controlled, even with your current inhalers (ICS-LABA) at medium to high doses?
Are you able to visit the study clinic regularly for assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either the new medicine, AZD4604, or a 'dummy' medicine called a placebo. You wouldn't know which one you're receiving, and neither would the study team, to keep things fair. You would take this study medicine twice a day for 12 weeks.

Throughout these 12 weeks, you would have several visits to the study clinic. During these visits, the medical team would perform various assessments. These might include checking your breathing using lung function tests, asking about your asthma symptoms, and completing questionnaires about how your asthma affects your daily life. They would also monitor your overall health and any side effects you might experience.

After the 12 weeks of taking the study medicine, there would likely be a follow-up visit or contact to check on your health and gather final information. The total duration of your participation in the study, including screening, treatment, and follow-up, would be fully explained to you before you make a decision.

Potential risks and benefits

Taking part in any clinical trial comes with potential benefits and potential risks. You might benefit if AZD4604 proves effective in improving your asthma or preventing flare-ups, but there's also a chance you could receive the dummy medicine and not experience any direct medical benefit from the study treatment itself. As with any new medicine, there's a possibility of side effects, and these would be carefully monitored and explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care, and your safety and well-being will be the priority of the study team throughout.

Locations (7)

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

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Unverified
Sweden
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Unverified
Bulgaria
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Unverified
France
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Unverified
Germany
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Unverified
Denmark
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Unverified
Spain
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Unverified
Netherlands

Common questions

What is a 'dummy' medicine or placebo?

A dummy medicine, or placebo, looks exactly like the real medicine but doesn't contain any active drug. Giving some people a placebo helps us see if the new medicine is truly making a difference compared to getting no active treatment.

What does 'uncontrolled' asthma mean?

Uncontrolled asthma means your symptoms, like wheezing, coughing, or breathlessness, are still bothering you often, or you're having asthma flare-ups, even though you're using your regular inhalers as prescribed.

What are 'asthma flare-ups'?

Asthma flare-ups, also called exacerbations, are periods when your asthma symptoms get much worse and might require extra treatment, such as steroid tablets or a trip to the GP or hospital.

How long will I need to take the study medicine?

If you join the study, you would take the study medicine (either AZD4604 or the dummy medicine) twice a day for a period of 12 weeks.

Will I know if I'm getting the new medicine or the dummy medicine?

No, neither you nor the study doctors will know whether you are receiving the new medicine or the dummy medicine. This is a common and important part of clinical trials to ensure fair and unbiased results.