Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Multicentre, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA)

The TITANIA study is investigating a new medicine called Tozorakimab for adults with Chronic Obstructive Pulmonary Disease (COPD). This study focuses on individuals who experience frequent flare-ups (exacerbations) of their COPD symptoms. We want to find out if Tozorakimab can help reduce how often these flare-ups happen and check if it's safe to use. Participants will be randomly assigned to receive either the new medicine or a dummy medicine (called a placebo), along with their usual COPD treatments like Salbutamol. This is a large study (Phase III) designed to confirm if Tozorakimab could be a helpful new treatment option for people living with COPD.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

AstraZeneca AB

Enrolment target

350

Start

03 Apr 2024

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

Imagine you have COPD, and sometimes your breathing gets much worse, needing extra treatment or even a hospital visit. These are called flare-ups or exacerbations. This study, called TITANIA, is specifically for people with COPD who experience these flare-ups often. Doctors and scientists are looking for new ways to help reduce how frequently these difficult episodes occur.

The main goal of this study is to test a new medicine called Tozorakimab. We want to see if this medicine can help people with COPD by making these flare-ups happen less often. We also want to understand if it's safe and how well people tolerate it. To get a clear answer, some participants will receive the new medicine, while others will get a 'dummy' medicine (called a placebo) that looks just like the real thing. This helps us fairly compare the new medicine's effects.

This kind of study is called a 'Phase III' study. This means it's one of the final steps before a new medicine might be approved for wider use. By taking part, you could be helping to find a new treatment that could improve the lives of many people with COPD in the future.

Key takeaways

This study tests a new medicine (Tozorakimab) for people with severe COPD.
It aims to reduce how often COPD flare-ups happen.
Participants will receive either the new medicine or a dummy medicine (placebo).
It's a large, important study (Phase III) to check safety and effectiveness.
Your general medical care will continue as normal during the study.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. Both men and women can take part.

You should have been diagnosed with COPD and experience noticeable symptoms. A key part of qualifying for this study is having a history of sudden worsening of your COPD, known as exacerbations, which may have required extra medicine or hospital visits.

More specific health checks will be done by the study team to make sure it's safe and appropriate for you to participate.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of COPD?
Do you have a history of COPD flare-ups (exacerbations)?
Are you able to attend regular clinic visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join the study, you'll have regular visits to the clinic. At these visits, doctors and nurses will check your health, ask about your symptoms, and carry out some tests. You'll receive either the new study medicine or a placebo, which you'll take regularly over a period of time. You'll also continue using your usual 'rescue' inhaler, like Salbutamol, as needed. The study team will monitor you closely to see how you're feeling and if there are any changes in your COPD or general health. The total duration of your involvement in the study, including follow-up checks, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving close medical monitoring and access to a new treatment before it's widely available. However, there are also potential risks involved, including possible side effects from the study medicine or the placebo. These will be fully explained before you decide to join. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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Poland
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Germany
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Italy
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France
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Romania
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Greece

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a group of lung conditions that cause breathing difficulties.

What is a 'flare-up' or 'exacerbation'?

This is when your COPD symptoms, like breathlessness, coughing, or wheezing, suddenly get much worse than usual, often needing extra treatment.

What does 'placebo' mean?

A placebo is a dummy medicine that looks exactly like the real study medicine but doesn't contain any active drug. It helps compare the new medicine's effects fairly.

Will I know if I'm getting the new medicine or the placebo?

No, neither you nor your study doctor will know if you're getting the new medicine or the placebo. This is called 'double-blind' and helps keep the study fair and unbiased.

What does a 'Phase III' study mean?

A Phase III study is a large, advanced stage of research designed to confirm if a new medicine is effective and safe before it can be considered for general use.