RecruitingPhase 4NCT06334575

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


Sponsor

Maria Joyera Rodríguez

Enrollment

135 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The 3TR-ICS COPD study is an international, multicentre, randomized, parallel, controlled study that will recruit clinically stable former smokers COPD patients (with no exacerbations in the previous 8 weeks) on treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage, not receiving ICS (either naïve or \> 3 months since last usage). The overall objective of this clinical trial is to identify the molecular signatures associated with the molecular response to ICS treatment in patients with COPD stratified by the levels of circulating eosinophils, and the potential influence of the pulmonary microbiome


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at which biological markers (patterns in genes, proteins, or immune cells) in the airways predict whether patients with COPD (chronic obstructive pulmonary disease) will benefit from inhaled corticosteroids (ICS) — a common type of inhaled medication. **You may be eligible if...** - You are 40 years or older - You are a former smoker (quit at least 6 months ago) with at least a 10 pack-year smoking history - You have confirmed COPD (a breathing test showing obstruction) - Your lung function is in the moderate-to-severe range (FEV1 between 30–80% of predicted) - You have been on two long-acting bronchodilator inhalers (LABA+LAMA) for at least 8 weeks **You may NOT be eligible if...** - You are currently smoking - You have had a COPD flare-up recently - You are pregnant or unable to use effective contraception - You are on inhaled steroids or have taken oral steroids recently - You have significant other lung or immune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBudesonide

receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks


Locations(6)

Philips University of Marburg

Marburg, Germany

Academisch Ziekenhuis Groningen

Groningen, Netherlands

Clínic Barcelona

Barcelona, Spain

Son Espases

Palma de Mallorca, Spain

University of Leicester

Leicester, United Kingdom

Imperial College London

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06334575


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