Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AZD8630, Administered Once Daily via Inhalation, for 2 Weeks, in Adults with Asthma on Medium-to-high Dose Inhaled Corticosteroids and Long-acting Beta-agonists

This research study is testing a new inhaled medicine called AZD8630 for people with asthma. It's an early-stage study, meaning it's one of the first times this medicine is being given to people. The main goals are to check if the medicine is safe to use and to understand how it works in the body. Researchers will also look at how the body handles the medicine and what effects it has. Participants will use the inhaler once a day for two weeks. This study is for adults whose asthma is currently managed with medium-to-high dose corticosteroid inhalers and long-acting beta-agonist inhalers, which are common treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

17 Oct 2024

Asthma

What is this study about?

Imagine you have asthma and are already using your regular inhalers, but doctors are always looking for even better ways to help. This study is a step in that direction.

It's called a 'Phase I' study, which means it's an early look at a new medicine. Think of it like a first test flight for a new plane – the main focus is making sure it's safe and understanding how it behaves. The new medicine is called AZD8630, and it's given as an inhaler, just like many asthma medications you might already know.

The study aims to answer a few important questions: Is AZD8630 safe for people with asthma? How does the body handle the medicine once it's inhaled (this is called 'pharmacokinetics')? And what effects does it have on the body (this is called 'pharmacodynamics')? By giving it once a day for two weeks, researchers hope to get a good initial understanding before larger studies are done.

Key takeaways

It's an early safety study (Phase I) for a new asthma inhaler (AZD8630).
Focuses on safety and how the medicine works in the body.
Participants will use the inhaler once daily for two weeks.
Open to adults (18+) with asthma already on specific routine inhalers.
Does not aim to cure asthma, but to gather important initial information.
You can stop participating at any time.

Who may be eligible?

This study is looking for volunteers who are adults, meaning you must be 18 years old or older. There is no upper age limit, so older adults can also take part if they meet the other criteria.

The study is open to both men and women.

Importantly, participants must have asthma and currently be using a specific type of treatment: a medium-to-high dose inhaled corticosteroid (a steroid inhaler) and a long-acting beta-agonist (another type of inhaler that helps open your airways). This means the study is for people whose asthma is already being managed with these common medications.

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 a diagnosis of asthma?
Are you currently using a 'medium-to-high dose' steroid inhaler?
Are you also currently using a 'long-acting beta-agonist' inhaler?
Are you able to commit to several clinic visits over a few weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new study medicine, AZD8630, as an inhaler. You would use it once a day for a period of two weeks. During this time, and possibly before and after, you would need to attend several appointments at the study clinic. These visits are important for the research team to monitor your health, check how you're reacting to the medicine, and carry out various tests. These tests might include breathing tests, blood samples, and physical examinations. The total length of your participation, including screening checks and follow-up, could extend beyond the two weeks of treatment.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit could be helping researchers find new ways to treat asthma, which might help future patients. For you personally, there's always the chance that the new medicine could help your asthma, though this is not the main goal of this early-stage study. However, like all medicines, AZD8630 could cause side effects, and some might not be known yet. The research team will carefully explain all known risks. It's crucial to remember that you are free to leave the study at any time, for any reason, without it affecting 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 AZD8630?

AZD8630 is a new medicine in an inhaler being tested for asthma. This study is one of the first times it's given to people.

Will this study cure my asthma?

No, this is an early-stage study focused on safety and understanding the medicine. It's not designed to cure asthma, but it contributes to finding better future treatments.

Do I have to stop my current asthma medicine to join?

No, this study is for people who are already on specific asthma medicines (medium-to-high dose inhaled corticosteroids and long-acting beta-agonists).

How long will I take the new medicine?

You will take the new medicine once a day for two weeks as part of this study.

What if I experience side effects?

The research team will monitor you closely. If you experience any side effects, you should tell them immediately. They will guide you on what to do.