Active not recruitingPHASE3INTERVENTIONAL

Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

This study is for adults, aged 40 and over, who have Chronic Obstructive Pulmonary Disease (COPD) and have previously experienced flare-ups. You must have already taken part in either the 'OBERON' or 'TITANIA' studies and completed your treatment in them. This phase 3 trial aims to look at the long-term safety and effectiveness of a new medicine called Tozorakimab. Some participants will receive Tozorakimab, while others will receive a 'placebo', which is a dummy treatment with no active medicine. This will help researchers understand if Tozorakimab helps reduce COPD symptoms and flare-ups over a longer period.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

1,713

Start

06 Mar 2023

Estimated completion

28 May 2026

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

This study is a continuation of previous research into a new medication called Tozorakimab for people living with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe, often causing symptoms like shortness of breath, coughing, and wheezing. People with COPD can also experience 'exacerbations' or 'flare-ups', which are periods when their symptoms suddenly get much worse.

The main goal of this particular study is to understand the long-term effects of Tozorakimab. We want to find out if it's safe to use over an extended period and if it can help improve symptoms and reduce the number of flare-ups for people with COPD. By comparing Tozorakimab to a placebo (a dummy treatment), researchers can get a clearer picture of the medicine's actual benefits.

This is a 'Phase 3' study, which means it's a large trial that builds on earlier research. Its findings are crucial for determining if Tozorakimab could become a new treatment option for people with COPD in the future. The information gathered will help make sure any potential new treatments are both effective and well-tolerated.

Key takeaways

This study is for adults aged 40+ with COPD and previous flare-ups.
You must have already completed the OBERON or TITANIA study.
It aims to check the long-term safety and effectiveness of a new medicine, Tozorakimab.
You'll either receive Tozorakimab or a dummy treatment (placebo).
Regular visits will monitor your health and how the treatment is working.
Your participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you must be at least 40 years old and have COPD with a history of flare-ups. Importantly, you must have already successfully completed one of the previous studies called OBERON or TITANIA, and your last dose of the study medicine from those trials must have been within the last 12 weeks. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test at the start of the study and agree to continue using contraception as you did in the previous studies.

There are also some reasons why you might not be able to join. For example, if you have other significant health issues that the study doctors feel might put you at risk or affect the study results, you wouldn't be eligible. You also can't be taking part in other drug trials at the same time. If you have a known severe allergy to similar types of medications or any ingredient in the study drug, you won't be able to participate. Lastly, if you regularly need medicines that suppress your immune system, you would also not be able to join.

Quick self-check

Are you 40 years old or older?
Do you have Chronic Obstructive Pulmonary Disease (COPD) with a history of flare-ups?
Have you completed either the OBERON or TITANIA study?
Is it less than 12 weeks since your last dose of study medicine in OBERON or TITANIA?
Are you able to attend regular clinic visits and follow study instructions?
Are you not currently taking part in another new drug trial (apart from OBERON/TITANIA)?

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, you'll be randomly assigned to receive either Tozorakimab or a placebo (a dummy medicine). You won't know which one you're receiving, and neither will your study doctor – this is called 'double-blind'. You'll have regular visits to the clinic where the study team will monitor your health, check your COPD symptoms, and perform various tests to assess your safety and how well the treatment is working. These tests might include physical exams, blood tests, and lung function tests. The study medication will likely be given to you at these visits. The study will continue for a period to assess the long-term effects, and the total duration will be explained in detail by the study team. You'll be asked to keep a record of any changes in your health or symptoms between visits.

Potential risks and benefits

Participating in this study might offer you the potential benefit of receiving a new medication that could improve your COPD symptoms or reduce flare-ups, although there's no guarantee as you might receive the placebo. You would also be closely monitored by medical professionals, which can be reassuring. Like all medications, Tozorakimab may have side effects, which the study team will explain in detail. There might also be some inconvenience due to clinic visits and tests. It's very important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (335)

Research Site
Sheffield, United States
Research Site
Tempe, United States
Research Site
Lincoln, United States
Research Site
Newport Beach, United States
Research Site
Northridge, United States
Research Site
Boynton Beach, United States
Research Site
Cape Coral, United States
Research Site
Ormond Beach, United States
Research Site
Pensacola, United States
Research Site
Plantation, United States
Research Site
Tampa, United States
Research Site
Winter Park, United States

+323 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 long-term lung condition that makes it difficult to breathe, often causing breathlessness, coughing, and wheezing.

What is Tozorakimab?

Tozorakimab is the name of the new investigational medicine being tested in this study. It's designed to help people with COPD, but it's not yet available as a standard treatment.

What does 'placebo' mean?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers understand if the benefits seen are truly due to the new medicine or other factors.

Why do I need to have been in another study already?

This study is an 'extension' of two earlier studies (OBERON and TITANIA). It’s designed to follow participants from those trials to gather long-term information on the medication's safety and effectiveness.

Can I leave the study if I change my mind?

Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your medical care.