Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

This research study is testing a new medication called astegolimab for people living with Chronic Obstructive Pulmonary Disease (COPD). The main goal is to find out if astegolimab can help reduce flare-ups (when your COPD symptoms get much worse) and improve overall health compared to a placebo (a dummy treatment with no active drug). We are looking for people aged 40 to 80 who have COPD and have a history of frequent flare-ups. Participants will either receive the new drug or the placebo, and researchers will carefully monitor their health and lung function. This study is in its final phase of testing, meaning it's getting closer to potentially being available to more patients if it proves effective and safe.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

1,290

Start

29 Dec 2022

Estimated completion

24 Sep 2027

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

You might be interested in this study if you have Chronic Obstructive Pulmonary Disease (COPD) and often experience flare-ups, where your breathing troubles get worse. This study is looking at a new treatment called astegolimab. The main aim is to see if this new drug can help prevent these difficult flare-ups and make you feel better overall, compared to taking a placebo.

The study is in a late stage, known as Phase 3. This means it has already been tested in smaller groups of people and is now being tried in a larger group to make sure it's safe and works well. By comparing the new drug to a placebo, researchers can get a clear picture of how effective astegolimab really is.

Taking part in this study could help researchers understand more about managing COPD and finding new ways to improve the lives of people with the condition. It's an important step in potentially bringing new treatment options to those who need them.

Key takeaways

This study is testing a new drug for people with COPD who have frequent flare-ups.
It aims to see if the new drug (astegolimab) can reduce flare-ups compared to a dummy treatment (placebo).
You might be eligible if you're aged 40-80, have COPD with frequent flare-ups, and a smoking history.
Participation involves regular clinic visits, medical checks, and taking the study medication or placebo.
Your health will be closely monitored throughout the study.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be between 40 and 80 years old and have a confirmed diagnosis of COPD for at least a year. A key part of qualifying is having a history of frequent COPD flare-ups – meaning at least two moderate or severe flare-ups in the past year. Your lung function will also be checked to make sure it falls within certain limits, and you should have quite bothersome breathlessness most days.

You also need to be a current smoker or have a significant smoking history. It's important that you've been on your regular COPD medications for at least a year and have been stable on them for at least a month before the study starts. We can't include people with certain other lung conditions like asthma or alpha-1 antitrypsin deficiency, or those who have had recent lung surgery or severe infections.

Quick self-check

Are you between 40 and 80 years old?
Do you have a diagnosis of COPD?
Have you had at least two COPD flare-ups in the last year?
Are you a current smoker or have you smoked significantly in the past?
Are you on stable COPD maintenance medication?
Do you NOT have asthma or certain other serious lung conditions?

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 be asked to attend several clinic visits over a period of time. At these visits, you would have various tests, such as lung function checks, blood tests, and health questionnaires. You would receive either the study drug, astegolimab, or a placebo (a dummy treatment) on a regular schedule, as instructed by the study team. The total duration of your participation, including follow-up, will be explained in detail by the study staff, but these types of studies often last for a year or more. You'll be closely monitored throughout the study to track your health, any side effects, and how well the treatment is working.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might benefit from closer medical monitoring and access to a new potential treatment that isn't widely available yet. However, there's no guarantee the treatment will help you, and you might experience side effects. The medications could also have unknown risks. You might receive the placebo, which means you won't get any active drug. All risks will be fully explained before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your usual medical care.

Locations (382)

University of Alabama at Birmingham
Birmingham, United States
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, United States
Pulmonary Associates PA
Glendale, United States
AES - DRS - Synexus Clinical Research US, Inc. - Tucson
Tucson, United States
Kern Research
Bakersfield, United States
Allergy & Asthma Medical Group of the Bay Area
Walnut Creek, United States
Finlay Medical Research Corporation
Greenacres City, United States
San Marcus Research Clinic Inc.
Miami, United States
Oceane7 Medical & Research Center, Inc.
Miami, United States
Avantis Clinical Research, LLC
Miami, United States
Research Institute of South Florida Inc
Miami, United States
Diverse Clinical Research, LLC
Miami, United States

+370 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 condition that causes breathing difficulties, usually because of long-term exposure to harmful gases or particles, often from smoking.

What is a 'flare-up'?

A COPD flare-up, or exacerbation, is when your breathing difficulties suddenly get much worse, and you might have more cough, phlegm, or wheezing than usual. These can be serious and sometimes need hospital treatment.

What is a placebo?

A placebo is a dummy treatment. It looks exactly like the real study drug but contains no active medicine. It helps researchers compare how well the new drug works against not taking any active medicine.

What is astegolimab?

Astegolimab is the new drug being tested in this study. It's an investigational medicine, meaning it's still being researched and is not yet approved for general use.

How long will the study last for me?

The exact length of your participation will be discussed by the study team, but clinical trials for COPD often involve follow-up over many months or even longer.