Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

This important study is investigating a new medication called tozorakimab for adults with Chronic Obstructive Pulmonary Disease (COPD). We're particularly interested in people who experience frequent flare-ups (exacerbations) of their COPD, where their symptoms suddenly get much worse. The main goal is to find out if tozorakimab, given as an injection under the skin, can help reduce the number of these flare-ups and improve how people feel day-to-day. Participants will already be on their usual COPD treatments and will either receive the new study medicine or a placebo (a dummy treatment). This is a 'Phase 3' study, meaning it's a large trial to confirm the treatment's safety and effectiveness before it might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,454

Start

22 Sep 2023

Estimated completion

22 May 2026

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

This study is looking into a new potential treatment for Chronic Obstructive Pulmonary Disease, often known as COPD. COPD makes it hard to breathe because of damage to the lungs, and it can cause symptoms like coughing, wheezing, and breathlessness. Some people with COPD experience sudden worsening of their symptoms, called 'flare-ups' or 'exacerbations'. These flare-ups can be very serious, sometimes requiring hospital stays.

The new medication being tested is called tozorakimab. Researchers want to see if this medicine can help people with COPD who have had several of these flare-ups in the past year, even when they are already using their regular inhalers.

By taking part, you would be helping doctors understand if tozorakimab is effective and safe. This kind of research is vital for finding better ways to manage COPD and improve the quality of life for people living with this condition.

Key takeaways

This study is for adults with COPD and a history of frequent flare-ups.
It's testing a new medication called tozorakimab as an injection.
Participants will continue their regular COPD inhalers.
You might receive the new medicine or a dummy treatment (placebo).
It's a 'Phase 3' study, meaning it's a large trial to confirm safety and effectiveness.
Your participation could help improve future COPD treatments.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a confirmed diagnosis of COPD for at least a year. You should also have had at least two moderate or one severe COPD flare-up in the last year. Importantly, for at least three months, you must have been using your regular prescribed inhalers for COPD, which might be a combination of two or three different medicines.

There are also some reasons why you might not be able to join. For example, if you have other significant lung conditions besides COPD, or if you currently have unstable health problems like certain heart, kidney, or gut issues. You also can't take part if you've recently had a COPD flare-up, a significant infection, or if you currently have or are suspected of having COVID-19.

This study is for people who have a history of smoking, specifically at least 10 'pack-years' (this means, for example, smoking one pack a day for 10 years, or half a pack a day for 20 years, and so on). Also, your COPD symptoms, particularly coughing and phlegm, should be affecting you noticeably.

Quick self-check

Are you 40 years old or older?
Do you have a confirmed diagnosis of COPD from your doctor (for at least a year)?
Have you had at least 2 moderate or 1 severe COPD flare-up in the last year?
Have you been regularly using your prescribed COPD inhalers for at least 3 months?
Do you have a history of smoking (e.g., 1 pack a day for 10 years)?
Are your COPD symptoms (like cough and phlegm) affecting you noticeably?

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 receive either the new medication, tozorakimab, or a placebo (a dummy treatment). These would be given as injections under the skin. You wouldn't know which treatment you are receiving, and neither would your study doctor, as this helps make sure the results are fair.

Throughout the study, you would continue to use your regular COPD inhalers as prescribed. You would have several visits to the clinic for health checks, breathing tests, and to make sure the treatment is safe for you. The exact number of visits isn't specified here, but clinical trials usually involve regular check-ups over a period of many months, sometimes a year or more, to carefully monitor your progress and any side effects. You'll be given all the details about the schedule of visits if you are interested in joining.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as contributing to medical knowledge and potentially receiving a new treatment that could improve your COPD symptoms and reduce flare-ups. However, there are also potential risks, including side effects from the study medication, which are not yet fully known. There is also no guarantee that the new treatment will be effective for you. You will be fully informed of all known risks before giving your consent, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (368)

Research Site
Birmingham, United States
Research Site
Decatur, United States
Research Site
Sheffield, United States
Research Site
Phoenix, United States
Research Site
Tucson, United States
Research Site
Yuma, United States
Research Site
Los Angeles, United States
Research Site
Newport Beach, United States
Research Site
San Francisco, United States
Research Site
Westminster, United States
Research Site
Aurora, United States
Research Site
Boulder, United States

+356 more sites — see the official record for the full list.

Common questions

What is Tozorakimab?

Tozorakimab is a new medication being tested to see if it can help people with COPD, especially those who have frequent flare-ups.

What is a 'flare-up' of COPD?

A COPD flare-up, or exacerbation, is when your COPD symptoms like breathlessness, cough, or phlegm suddenly get much worse than usual, sometimes needing extra treatment or hospital care.

Will I still take my regular inhalers if I join?

Yes, you must continue taking your usual COPD inhaler medications throughout the study, even if you are receiving the new study medication.

What is a 'placebo'?

A placebo is an inactive dummy treatment that looks just like the real medicine. It helps researchers fairly compare the new medication's effects.

How long will the study last?

The information provided does not specify the exact duration, but Phase 3 studies typically involve regular check-ups over several months or longer. You will be given a full schedule if you consider joining.