Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase Ib, Multicentre, Randomised, Single-blind, Parallel-group, Placebo-controlled, Study to Characterise the Pharmacokinetics and Pharmacodynamics of AZD4604 Administered via the Turbuhaler® Device in Adults with Mild Asthma

This research study is looking at a new medication called AZD4604 for adults who have mild asthma. The medicine is given using a special inhaler device called a Turbuhaler®. Researchers want to understand how this new medicine travels through your body and what effects it has over time. They will compare it to a 'placebo', which is a dummy treatment with no active medicine. This early-stage study helps scientists learn more about new treatments by carefully checking how they work and if they are safe. It’s part of the process to develop new and better ways to help people manage their asthma symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

21 Nov 2024

Asthma

What is this study about?

This study is about a new medicine called AZD4604 for people with mild asthma. Asthma is a common condition that makes breathing difficult for some people. Researchers are trying to find new and better ways to help manage asthma.

In this study, the new medicine AZD4604 is given using an inhaler device called a Turbuhaler®. The main goal is to understand how your body handles this medicine. This is like understanding how a car uses fuel – how quickly it gets into the system, how long it stays there, and what effects it has. The study also looks at how the medicine affects your asthma.

To make sure they get clear results, some people in the study will get the new medicine, while others will get a placebo. A placebo looks exactly like the real medicine but contains no active ingredients. This helps researchers compare the effects of the new medicine against doing nothing special. This is an early stage of testing new medicines, often called a 'Phase Ib' study, which focuses on safety and how the medicine works in the body.

Key takeaways

New medicine called AZD4604 being tested for mild asthma.
Given through a common inhaler device (Turbuhaler®).
Study aims to understand how the medicine works in the body.
Compares the new medicine to a dummy treatment (placebo).
Only for adults aged 18 and over with mild asthma.
Early stage research (Phase Ib) focusing on safety and how the medicine behaves.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older. There is no upper age limit, meaning older adults are welcome to take part too.

Both men and women can participate in this study. The researchers want to make sure the new medicine is tested on a wide range of people.

However, it's important to remember that this study is specifically for people who have *mild asthma*. If your asthma is severe or you have other complex health conditions, you might not be suitable for this particular study. A doctor at the study site would check your full health history to see if it's right for you.

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 mild asthma?
Are you generally in good health apart from your asthma?
Are you able to use an inhaler properly?
Are you willing to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

Taking part in a study like this usually involves several visits to a clinic. You might have blood tests, breathing tests (like spirometry to check your lung function), and physical exams. You would also be given the study medication, which could be the new drug or a placebo, to take regularly using the Turbuhaler® device. Researchers would carefully monitor you for any changes in your asthma symptoms or any side effects. You'd likely keep a diary to record how you're feeling and when you take your medication. The total time you spend in the study, from your first visit to your last follow-up, can vary but is usually a few weeks to a few months.

Potential risks and benefits

Potential benefits of joining could include getting access to a new asthma medicine before it's widely available and receiving expert medical care throughout the study. However, there's no guarantee the new medicine will help you, and you might receive a placebo. Potential risks are possible side effects from the medication, which would be explained in full detail by the study team. You have the right to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is a 'Turbuhaler® device'?

It's a common type of inhaler that delivers medicine directly into your lungs when you breathe in.

What is 'mild asthma'?

Mild asthma means your symptoms are generally well-controlled with occasional use of a reliever inhaler, and don't seriously affect your daily life.

What does 'placebo-controlled' mean?

It means some people will get the new medicine, and others will get an inactive dummy treatment that looks the same, to help compare the effects fairly.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'single-blind' study, meaning you won't know if you're getting the active medicine or the placebo. This helps prevent your expectations from affecting the results.

What does 'pharmacokinetics and pharmacodynamics' mean?

These are scientific terms. Pharmacokinetics is how your body handles the medicine (how it's absorbed, distributed, broken down, and leaves the body). Pharmacodynamics is what the medicine does to your body and how it works.