RecruitingPHASE2INTERVENTIONAL

Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD

For people living with COPD, this study is testing a new medicine called tezepelumab. This medicine is designed to reduce inflammation in the lungs, which can make breathing difficult and lead to flare-ups or exacerbations. Around 80 participants will take part, receiving either tezepelumab or a dummy medicine (placebo) by injection over 20 weeks. Researchers want to understand if tezepelumab can help improve lung health and reduce the immune system's overreaction to triggers that make COPD worse. The study is a Phase 2 trial, meaning it's an early stage of testing to see how well the medicine works and if it's safe.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Asger Sverrild

Enrolment target

Start

25 Oct 2022

Estimated completion

31 Dec 2025

COPD COPD Exacerbation COPD Bronchitis Airway Disease Immune System Disorder

What is this study about?

If you have COPD, you know that breathing can be tough, and sometimes your condition suddenly gets much worse – these are called exacerbations or flare-ups. These flare-ups often happen because of inflammation in your airways and how your immune system reacts to different triggers. This study is looking into a new medicine called tezepelumab that might help calm down this inflammation and the immune system's response.

The main idea behind this research is to see if tezepelumab can make a real difference for people with COPD. By reducing airway inflammation, the hope is that participants might experience fewer and less severe flare-ups, leading to better overall lung health and quality of life. The study is particularly interested in people who have had at least one flare-up in the past year, as they are often the ones who struggle most with ongoing symptoms.

This is a 'Phase 2' study, which means it's an important step in developing new treatments. Researchers are carefully checking how well tezepelumab works and if it's safe for people with COPD. By comparing it to a placebo (a dummy medicine), they can get a clearer picture of its effects. The results from studies like this help decide if a medicine should move on to larger trials and eventually become available to more people.

Key takeaways

This study is testing a new medicine called tezepelumab for COPD.
It aims to reduce airway inflammation and prevent COPD flare-ups.
Participants will receive injections of either tezepelumab or a placebo for 20 weeks.
The study is for people with COPD who have had recent flare-ups.
This is an early-stage study to check effectiveness and safety.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a confirmed diagnosis of COPD. You should have a history of smoking, either currently or in the past, for at least 10 years. Your lung function, measured by a test called FEV1, needs to be within a specific range – not too low, but also not too high.

It's important that you've been taking regular COPD medicines (specifically LAMA and LABA, and possibly ICS) for at least three months, and your doses should have been stable. Also, you must have experienced at least one COPD flare-up that needed treatment with steroids or antibiotics in the last 12 months. When you come for screening, you'll need to show you can use your inhalers correctly and do breathing tests properly.

Some things might mean you can't join. For example, if you have other serious health problems that aren't well controlled, or if another lung condition would make it hard to see how effective the study medicine is. If you're a woman who could become pregnant, you'll need to agree to use effective contraception throughout the study.

Quick self-check

Are you 40 years old or older?
Do you have a diagnosis of COPD?
Have you smoked for at least 10 years (even if you've quit)?
Have you had at least one COPD flare-up needing steroids or antibiotics in the last year?
Are you currently taking LAMA and LABA inhalers (and possibly ICS) and have been for at least 3 months?

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 assigned by chance to either receive the study medicine, tezepelumab, or a placebo (a dummy injection that looks like the real medicine but has no active drug). Neither you nor your study doctor will know which one you're receiving – this is called 'double-blind'.

The medicine or placebo will be given as an injection under your skin, right at the study clinic, over a period of 20 weeks. You'll need to attend the clinic regularly for these injections and for various assessments. These assessments will likely include breathing tests (spirometry), checking your inhaler technique, blood tests, and discussions about your symptoms and any side effects you might experience. There will also be screening visits before treatment begins and follow-up after the 20 weeks of treatment to monitor your health. The total time you'd be involved in the study would include these screening and follow-up periods.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new treatment that could improve your COPD symptoms, but there's no guarantee the study medicine will help you, or you might receive the placebo. There could be side effects from the study medicine, or risks associated with the injections or tests. All potential risks will be thoroughly explained to you before you agree to participate. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (2)

Research site
Copenhagen, Denmark· Recruiting
Research site
Leicester, United Kingdom· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a lung condition that makes it hard to breathe because of narrowed airways.

What is a 'flare-up' (exacerbation) of COPD?

A flare-up is when your COPD symptoms suddenly get worse, like more coughing, breathlessness, or phlegm, and you might need extra medicine or hospital care.

What is tezepelumab?

Tezepelumab is the medicine being tested. It's designed to calm down inflammation and the immune system's response in the airways.

What does 'placebo-controlled' mean?

It means some participants will get the study medicine and some will get a dummy injection (placebo) that looks the same but has no active drug. This helps researchers see if the medicine really works.

How will the medicine be given?

The medicine or placebo will be given as an injection under the skin at the study clinic.

How to find out more

Kristoffer Norheim, PhD

kristoffer.norheim@regionh.dk +4542831337 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.