Erdosteine effect on oxidative stress, inflammatory response and immune modulation in patients with COPD. A single center, open label, double arm, controlled, 4-week, explorative, ex vivo study.
This study aims to understand how a medicine called erdosteine might help people with Chronic Obstructive Pulmonary Disease (COPD). Specifically, it's looking at how erdosteine affects 'oxidative stress' (which is like rust in the body's cells), inflammation, and the immune system. Researchers will give some patients erdosteine along with their standard COPD care, while others will just receive standard care. Over four weeks, they will take blood samples to see if there are any changes in certain markers related to these body processes. This is an early-stage study to learn more about the drug's effects.
At a glance
What is this study about?
This study is about a medicine called erdosteine and how it might help people who have Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe. Researchers are interested in how erdosteine affects three key areas in the body: oxidative stress, inflammation, and the immune system. Oxidative stress is when there's an imbalance of certain chemicals in your body that can damage cells, a bit like rust. Inflammation is your body's response to injury or infection, but too much can be harmful. The immune system is your body's defence against illness.
The main goal of the study is to see if taking erdosteine, alongside a patient's usual care, changes the levels of a specific protective protein called GPX2 in their blood after 30 days. GPX2 is involved in protecting cells from damage. The researchers will compare people who take erdosteine with their usual care to those who only receive their usual care. They will do this by looking at blood samples taken at the start and end of the study.
The study will also check for changes in other markers related to inflammation and the immune system. By looking at these different parts of the body's response, researchers hope to get a clearer picture of how erdosteine works and whether it could be a helpful treatment for people with COPD. This is an exploratory study, meaning it's designed to gather initial information rather than prove a treatment is effective.
Key takeaways
- The study investigates erdosteine's effects on COPD.
- It focuses on inflammation, oxidative stress, and the immune system.
- Participation involves 4 weeks of treatment and blood tests.
- It's an 'open label' study, so you'll know your treatment group.
- The findings could help improve future COPD treatments.
- You can withdraw from the study at any time.
Who may be eligible?
To be eligible for this study, you must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can take part as long as they meet other requirements.
Both men and women are welcome to participate in this study. The researchers want to include a diverse group of people to ensure the findings are relevant to everyone with COPD.
Crucially, you would need to have a diagnosis of COPD. The study details do not mention specific severity levels, but your doctor would be able to check if your particular situation fits the study's precise criteria.
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 COPD?
- Are you able to attend appointments for blood tests?
- Are you currently receiving standard care for your COPD?
What does participation involve?
If you decide to take part in this study, you would be assigned to one of two groups: one receiving erdosteine alongside your usual COPD care, and the other receiving only your usual care. The study lasts for 4 weeks.
Throughout these 4 weeks, you would continue your regular COPD treatment. The main part of your involvement would be attending appointments where blood samples are taken. These blood samples will help the researchers measure the changes they are looking for. The study will not involve any special visits beyond what is needed for blood tests. You will not need to change your lifestyle significantly, other than possibly taking the study medication if you are in that group. There will be no long-term follow-up after the 4-week treatment period is complete. The exact number of visits for blood samples is not specified but would be discussed thoroughly before you agree to participate.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, usually caused by long-term exposure to harmful gases or particles, most often from smoking.
What is erdosteine?
Erdosteine is a medicine that helps to thin mucus in the lungs, making it easier to cough up. It also has properties that might reduce inflammation and protect cells.
Will I know if I'm getting the drug or not?
This study is 'open label,' meaning you and your doctors will know if you are receiving erdosteine or are in the comparison group receiving only standard care.
How long will the study last for me?
Your active participation in the study will last for 4 weeks, during which you will have appointments for blood samples.
What is 'standard of care'?
Standard of care means the usual, accepted medical treatments and practices that people with COPD generally receive from their doctors.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.