A Randomised, Double-blind, Parallel Group, Placebo Controlled, 4-Week, Phase II Study to Evaluate the Effect of AZD4604 on Airway Inflammation and Biomarkers in Adults with Asthma - Artemisia study
The Artemisia study is a research project for adults with asthma. It's looking into a new medicine called AZD4604. Researchers want to see if this medicine can reduce inflammation in the airways, which is a key part of asthma. For four weeks, some participants will receive the new medicine, while others will get a dummy medicine (a placebo). This is a 'blinded' study, meaning neither you nor your doctor will know if you're taking the real medicine or the placebo until the study ends. This helps make the results fair and accurate. The main aim is to understand how the new medicine changes certain markers in the airways that are related to inflammation. This is an early stage study (Phase II) to gather more information about how this potential new treatment works.
At a glance
What is this study about?
The Artemisia study is investigating a new medicine called AZD4604 for people living with asthma. Asthma is a common condition that affects your airways, making them inflamed and sometimes narrow, which can lead to coughing, wheezing and breathlessness. This study aims to understand *how* AZD4604 works in the body to hopefully reduce this inflammation.
Researchers will compare AZD4604 with a 'placebo', which looks exactly like the real medicine but contains no active ingredient. This is a standard way to test new medicines fairly, so we can be sure any improvements are due to the medicine itself. Neither you nor your study doctor will know whether you're receiving the active medicine or the placebo during the study – this is called a 'double-blind' approach.
The main goal is to look at changes in your airways to see if the medicine affects certain genes and processes related to inflammation. They will collect small samples from your airways, specifically from the lining of your breathing tubes. They'll also look at changes in different types of cells in your airways, including inflammatory cells, to see if the medicine has an effect. This study is an important step in learning more about AZD4604 and whether it could be a useful treatment for asthma in the future.
Key takeaways
- This study is for adults with asthma.
- It's testing a new medicine called AZD4604 for asthma inflammation.
- You might receive the new medicine or a dummy medicine.
- The study lasts about four weeks for treatment, plus follow-up.
- It involves clinic visits and airway sample collections.
- Your participation could help develop future asthma treatments.
Who may be eligible?
This study is open to adults who are 18 years old or older. You could be male or female.
To join, you must have a doctor's diagnosis of asthma. The research team will need to check your medical history to make sure taking part is safe for you and that you meet all the study requirements. This might include checking what other medicines you take and if you have any other health conditions. They will also assess your asthma to ensure it's suitable for this particular study.
It's important to remember that even if you meet these basic criteria, there might be other reasons why you can't join. The study team will explain everything to you in detail.
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 willing to attend regular clinic visits?
- Are you comfortable with having small samples taken from your airways?
- Are you available for the four-week treatment period plus follow-up?
- Are you willing to take study medication as directed?
What does participation involve?
If you decide to take part, the study will last for approximately four weeks during which you will receive either the new medicine (AZD4604) or a dummy medicine. You'll have regular visits to the clinic to monitor your health and how you're responding to the treatment. These visits will involve various medical checks, such as physical exams and possibly blood tests.
A key part of this study will be taking small samples from your airways, specifically brushings and tiny tissue samples (biopsies). These procedures are done in a clinic setting and are designed to help researchers understand the effects of the medicine on your inflammation. You'll also likely need to complete questionnaires about your asthma symptoms. After the four-week treatment period, there will be a follow-up period to ensure your well-being. The total duration of your participation, including follow-up, will be explained fully by the study team.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedDenmark
- —UnverifiedSpain
Common questions
What is AZD4604?
AZD4604 is a new medicine being tested to see if it can help reduce inflammation in the airways for people with asthma.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you're receiving the active medicine or a dummy medicine until the study is over.
How long will I be in the study?
You will receive the study medicine for four weeks, and there will be a follow-up period after that. The total time will be explained by the study team.
Will I have to have any procedures?
Yes, the study involves taking small samples from your airways, like brushings and small tissue samples (biopsies), to understand how the medicine works.
Can I stop participating if I want to?
Absolutely. You can withdraw from the study at any time without having to give a reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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