A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
This research study is looking at a new medicine called AZD6793 for people who have moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). It's a 'Phase IIb' study, which means it's testing different dose levels of the medicine to find the most effective and safest amount. We want to see how well AZD6793 works compared to a 'placebo' (a dummy pill with no active medicine). The study will also carefully check for any side effects. About 1160 people around the world will take part. The aim is to find better ways to help people living with COPD.
At a glance
What is this study about?
Living with Chronic Obstructive Pulmonary Disease (COPD) can be challenging, and researchers are always looking for new and better treatments. This particular research study is focused on a new medicine called AZD6793. Doctors and scientists want to understand if this medicine can help people with COPD who experience moderate to very severe symptoms.
The study will compare AZD6793 with a 'placebo', which is a tablet that looks exactly like the study medicine but contains no active ingredients. This helps researchers figure out if any changes people feel are actually due to the medicine or just because they are expecting to feel better. Participants will be given either the new medicine (at one of three different dose levels) or the placebo. All participants are monitored closely throughout the study for a period of about 24 weeks.
By taking part, you could be helping to find a new treatment that might improve the lives of many people with COPD in the future. Even if the medicine doesn't help you personally, the information gathered from your participation is incredibly valuable for medical science.
Key takeaways
- This study is testing a new medicine (AZD6793) for moderate to severe COPD.
- It aims to find out if the medicine is safe and effective compared to a dummy pill.
- Participation involves regular visits and health checks over about 6 months.
- You will either receive the new medicine or a placebo, and neither you nor the doctors will know which.
- Your health and safety would be closely monitored throughout.
- Participation could help improve future treatments for COPD.
Who may be eligible?
To join this study, you need to be at least 40 years old and have had a diagnosis of COPD for at least a year. Your COPD symptoms should be moderate to very severe, and you should have experienced at least two flare-ups (worsening of symptoms) in the last year, or one severe flare-up that needed hospital treatment.
You also need to be a current or ex-smoker with a significant smoking history. It's important that you've been on a stable dose of your usual inhaled COPD medicines for at least three months before the study starts. You should also be feeling stable and free from a COPD flare-up for at least four weeks before starting the study treatment.
There are also some reasons why you might not be able to join. For example, if you have other serious lung diseases like asthma or significant heart problems, or if you've had a recent heart attack or specific heart surgeries. The research team will carefully check your health to make sure the study is a safe option for you.
- Are you 40 years old or older?
- Do you have a confirmed diagnosis of COPD?
- Have you had at least two COPD flare-ups in the last year, or one severe one?
- Have you been on a stable dose of your regular inhaled COPD medicines for at least 3 months?
- Are you generally stable and free from a COPD flare-up in the last 4 weeks?
- Do you currently smoke or have you smoked in the past?
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, you would visit the study clinic several times over approximately 24 weeks (about six months). During these visits, doctors and nurses will carry out various health checks, such as breathing tests, blood tests, and check your general health. You will be given either the study medicine (AZD6793) or a dummy pill (placebo) to take regularly.
Throughout the study, the team will monitor you closely to see how you are responding to the treatment and to check for any side effects. You will have regular appointments to see the study doctors and nurses, and they will be there to answer any questions you have and provide support. Your health and safety will be the main priority.
Potential risks and benefits
Locations (366)
- Research SiteBirmingham, United States· Recruiting
- Research SiteGlendale, United States· Withdrawn
- Research SitePhoenix, United States· Recruiting
- Research SitePhoenix, United States· Recruiting
- Research SitePhoenix, United States· Recruiting
- Research SiteCanoga Park, United States· Withdrawn
- Research SiteLa Mesa, United States· Withdrawn
- Research SiteLos Angeles, United States· Recruiting
- Research SiteNewport Beach, United States· Recruiting
- Research SiteNorco, United States· Recruiting
- Research SiteTustin, United States· Recruiting
- Research SiteLakewood, United States· Withdrawn
+354 more sites — see the official record for the full list.
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung disease that causes breathing difficulties, mostly in people over 35 who smoke or used to smoke.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. This helps researchers check if the new medicine is truly effective.
Will I know if I'm getting the active medicine or the placebo?
Neither you nor the study doctors will know if you are receiving AZD6793 or the placebo. This is called 'double-blind' and it helps make sure the study results are fair and unbiased.
How long will the study last?
If you join, you would be taking part in the study for about 24 weeks, which is roughly six months.
What if I experience side effects?
The study team will monitor you closely for any side effects. It's very important to tell them about any new or worsening symptoms you experience so they can support you and make adjustments if needed.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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