A PHASE III, 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 into a new treatment called astegolimab for adults who have Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe. The main goal is to find out if astegolimab can lower the number of times people have moderate or serious flare-ups of their COPD over 52 weeks (about a year). Researchers also want to check how safe astegolimab is and if it helps with quality of life, lung function, and other symptoms. Half the people will get astegolimab, and the other half will get a placebo (a dummy medicine) in a process where neither the patients nor the doctors know who is getting what until the study ends.
At a glance
What is this study about?
This study is a medical trial exploring a new potential treatment for Chronic Obstructive Pulmonary Disease, often called COPD. COPD is a common lung condition that makes it difficult to breathe, and it can cause periods where symptoms suddenly get much worse, known as flare-ups or exacerbations. These flare-ups can be very serious and sometimes require hospital stays.
In this study, researchers are testing a medicine called astegolimab to see if it can help reduce how often people with COPD experience these flare-ups. They also want to understand if the medicine is safe to use and if it improves other important aspects of health, like how well people can breathe and their overall quality of life. The study will last for about a year, and during this time, researchers will carefully monitor participants.
To get clear results, the study is designed so that some people will receive the new medicine, astegolimab, while others will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers compare the effects of the new medicine against no active treatment. Neither the participants nor their study doctors will know who is getting which treatment until the study is over. This is a common and important way to ensure the study results are reliable and unbiased.
Key takeaways
- This study is testing a new medicine called astegolimab for COPD.
- It aims to see if the medicine can reduce COPD flare-ups and is safe.
- Participants will receive either astegolimab or a placebo (dummy medicine).
- Nobody in the study will know which treatment they are receiving until the end.
- The study typically involves regular clinic visits over about one year.
- You can discuss your eligibility and any concerns with your doctor and the study team.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or older. Both men and women can take part.
Beyond these basic requirements, the study will have specific health criteria to make sure it's suitable and safe for you. For example, your medical history, current health status, and specific details about your COPD will be carefully reviewed by the study team. They will also look at any other medicines you are currently taking.
It's important to remember that meeting the age and gender requirements is just the first step. The study doctors will need to check many other things to see if this study is the right fit for you. They will explain everything clearly and answer any questions you have.
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 Chronic Obstructive Pulmonary Disease (COPD)?
- Are you able to visit the clinic regularly for about a year?
- Are you willing to potentially receive an investigational medicine or a placebo?
- Are you able to provide your informed consent to participate?
What does participation involve?
If you decide to take part in this study, you will visit the clinic regularly over a period of about 52 weeks (one year). During these visits, you'll have appointments where the study team will:
* **Review your health:** They'll ask about your symptoms, any changes in your health, and if you've had any COPD flare-ups. * **Perform medical checks:** This might include tests like measuring your lung function (how much air you can breathe in and out), taking blood samples, and doing electrocardiograms (ECGs) to check your heart. * **Give you the study medicine:** You will receive either astegolimab or a placebo, likely as an injection, as scheduled by the study team. Remember, neither you nor your study doctor will know which one you are receiving. * **Ask about your quality of life:** You might fill out questionnaires about how your COPD affects your daily life and well-being.
There will also be follow-up calls or visits to monitor your progress and safety. The exact number and timing of visits will be explained in detail by the study team.
Potential risks and benefits
Locations (16)
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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, often caused by smoking or exposure to harmful fumes.
What is 'astegolimab'?
Astegolimab is the name of the new medicine being tested in this study. It's an investigational drug, meaning it's not yet approved for public use.
What does 'placebo' mean?
A placebo is a 'dummy' medicine that looks like the real medicine but doesn't have any active ingredients. It's used to compare the effects of the new medicine.
What is a 'flare-up' (exacerbation) of COPD?
A COPD flare-up is when your breathing difficulties and other symptoms suddenly get much worse than usual. These can range from moderate to severe.
How long will the study last if I join?
If you decide to join, the main treatment part of the study will last for about 52 weeks, which is roughly one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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