RecruitingPHASE4INTERVENTIONAL

Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels

This study, called 3TR-ICS COPD, is an international research project for former smokers with COPD who are already taking two types of breathing-improving medications. It's investigating how a common steroid inhaler, budesonide, works differently in patients based on their 'eosinophil' levels (a type of white blood cell) and the types of germs found in their lungs. The main goal is to find special 'markers' in the body that can predict who will benefit most from this treatment. Understanding these differences could help doctors personalise COPD treatment better in the future.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Maria Joyera Rodríguez

Enrolment target

135

Start

12 Feb 2025

Estimated completion

01 Dec 2027

Chronic Obstructive Pulmonary Disease

What is this study about?

This study is designed to understand why a common inhaler medication called budesonide, often used in COPD, works well for some patients but not as well for others. Researchers believe that specific things in a patient's body, like the levels of certain white blood cells called 'eosinophils' and the mix of bacteria and other tiny organisms in their lungs (the 'pulmonary microbiome'), might play a big role in how they respond to treatment.

The study involves patients with Chronic Obstructive Pulmonary Disease (COPD) who have given up smoking and are already using two different long-acting inhalers. Researchers will give them budesonide and carefully monitor their health. They will collect samples to look for 'molecular signatures' – think of these as unique patterns or markers in the body – that are linked to whether the budesonide treatment is effective.

By identifying these signatures, doctors might one day be able to predict if a patient will respond well to budesonide before they even start taking it. This could lead to more personalised and effective treatments for people living with COPD, helping them manage their condition better.

Key takeaways

Aims to understand why budesonide works differently in COPD patients.
Focuses on eosinophil levels and lung germs.
For former smokers with COPD already on two types of inhalers.
Could lead to more personalised COPD treatments.
Regular check-ups and samples involved if you participate.

Who may be eligible?

To be considered for this study, you need to be at least 40 years old and have a confirmed diagnosis of COPD. You must have smoked in the past but have stopped completely for at least six months. You also need to be currently using two specific daily inhalers (LABA+LAMA) for at least eight weeks, and shouldn't have used any steroid inhalers in the last three months.

There are also some reasons why you wouldn't be able to join. For example, if you have other lung conditions like active asthma or bronchiectasis, or if you're currently using long-term oxygen therapy. You also can't participate if you've had a recent flare-up of your COPD (an 'exacerbation') in the last two months, or if you are pregnant, breastfeeding, or have certain immune system problems.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 40 years old?
Do you have a diagnosis of COPD?
Are you a former smoker (stopped at least 6 months ago)?
Are you currently using two long-acting inhalers daily (LABA+LAMA)?
Have you avoided steroid inhalers for at least the last 3 months?
Have you not had a COPD flare-up in the last 8 weeks?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly assigned to receive the study medication, budesonide, alongside your current dual inhalers. Over the course of the study, you'll attend several visits to the clinic for check-ups, assessments, and to provide samples, such as blood or sputum. Researchers will closely monitor your health and how you respond to the treatment. The total number of visits and the exact duration of your participation will be explained in detail by the study team, but typically, these types of studies involve regular follow-ups over several months.

Potential risks and benefits

Participating in this study might offer you a potential benefit of closely monitored care for your COPD and access to a medication being studied in a controlled way. However, like all medications, budesonide can have side effects, which will be fully explained to you. There's also the chance the treatment may not help your condition. You are free to withdraw from the study at any time without explaining why, and this will not affect your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Philips University of Marburg
Verified postcode
Marburg, Germany· Recruiting
Academisch Ziekenhuis Groningen
Verified postcode
Groningen, Netherlands· Recruiting
Clínic Barcelona
Verified postcode
Barcelona, Spain· Recruiting
Son Espases
Verified postcode
Palma de Mallorca, Spain· Recruiting
University of Leicester
Verified postcode
Leicester, United Kingdom· Not yet recruiting
Imperial College London
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What are eosinophils?

Eosinophils are a type of white blood cell that play a role in your immune system, especially with allergies and fighting certain infections. High levels can sometimes indicate specific types of inflammation.

What does 'molecular signatures' mean?

Molecular signatures are like unique patterns in your body's cells, genes, or other substances that can help doctors understand who might respond to a certain treatment or what's happening with a disease.

Is budesonide a new medication?

No, budesonide is a well-established steroid inhaler that has been used for many years to treat conditions like asthma and COPD. This study is looking at how it works in more detail.

Can I still take my regular COPD inhalers?

Yes, you must be consistently using two specific long-acting bronchodilator inhalers (LABA+LAMA) for at least 8 weeks before joining and continue them throughout the study.

What is the 'pulmonary microbiome'?

This refers to all the tiny germs, like bacteria and fungi, that naturally live in your lungs. Researchers are exploring if the types of germs present affect how you respond to treatment.

How to find out more

Rosa Faner

rfaner@recerca.clinic.cat +34932775400 Official trial record

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