A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease
This research study is looking at a new medicine called astegolimab for people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe. The main goal of the study is to find out if astegolimab can lower the number of serious breathing problems, called exacerbations or flare-ups, that people with COPD experience over one year. Researchers also want to see if this medicine makes people feel better, breathe more easily, and if it's safe to use. This kind of study helps us learn more about potential new treatments that could one day help people living with COPD.
At a glance
What is this study about?
This study, called a Phase IIb trial, is designed to carefully test a new medicine called astegolimab for people who have a lung condition known as Chronic Obstructive Pulmonary Disease, or COPD. COPD causes breathing difficulties, and sometimes people have sudden worsening of their symptoms, which are called flare-ups or exacerbations.
The main purpose of this research is to see if astegolimab can reduce how often these flare-ups happen over a year. The study also wants to understand if the new medicine can make a difference in how people feel and if it's safe. To do this, some participants will receive astegolimab, while others will receive a 'dummy' treatment (placebo) – neither you nor your study doctor will know which you are getting. This helps us ensure the results are accurate and fair.
Researchers will also be looking at other important things, like how the medicine affects your quality of life (how well you feel and can do daily activities), your breathing ability, and how your symptoms change over time. By carefully studying these different aspects, doctors can learn more about astegolimab and whether it could be a helpful treatment option for people with COPD in the future.
Key takeaways
- This study is testing a new medicine called astegolimab for COPD.
- The main goal is to see if it reduces flare-ups (exacerbations).
- It also checks if the medicine improves breathing and quality of life.
- Participants will receive either the study medicine or a placebo.
- The study lasts about one year, with regular health checks.
- Participation involves potential benefits but also risks like side effects.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
There will be other specific health requirements that your study doctor will check to make sure the study is a good fit for you and that it's safe for you to participate. These might include details about your COPD, other health conditions you have, or medications you are currently taking.
It's important to have an open conversation with your doctor about all your medical history to see if you meet all the criteria for the study. They can explain everything in detail.
- Are you 18 years old or older?
- Have you been diagnosed with Chronic Obstructive Pulmonary Disease (COPD)?
- Are you generally able to attend regular clinic visits for about a year?
- Are you willing to potentially receive either the new medicine or a placebo?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, it would involve several visits to a clinic over a period of about 52 weeks (roughly one year). During these visits, you would receive either the study medicine (astegolimab) or a placebo, which looks like the medicine but contains no active drug. You wouldn't know which one you are getting.
Throughout the study, the research team would regularly check your health. This would include tests to measure your breathing, questionnaires about your symptoms and how you feel, and blood tests to check how your body is reacting to the treatment. They would also keep a close eye on any side effects you might experience. After the 52-week treatment, there would likely be some follow-up appointments to check your health.
Potential risks and benefits
Locations (11)
- —France
- —Romania
- —Denmark
- —Czechia
- —Belgium
- —Poland
- —Sweden
- —Spain
- —Germany
- —Bulgaria
- —Netherlands
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe.
What is astegolimab?
Astegolimab is a new medicine being tested to see if it can help people with COPD by reducing their breathing flare-ups.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know if you are receiving the new medicine or a 'dummy' treatment (placebo), so the results are not influenced.
Will my regular COPD treatment stop if I join?
This will depend on the study's specific rules. You should discuss all your current medications with the study team before participating.
How long does the study last?
The main part of the treatment will last about 52 weeks, which is roughly one year, with some follow-up afterwards.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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