Actively Recruiting
Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Led by Maria Joyera Rodríguez · Updated on 2026-03-05
135
Participants Needed
6
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 60 years of age.
- At least 10 pack-years smoking history.
- Former smokers for 6 months or more.
- Post-bronchodilator FEV1/FVC ratio less than 0.70.
- FEV1 30% to less than 80% of predicted.
- Signed written informed consent.
- On regular treatment with dual long-acting bronchodilators (LABA+LAMA) for at least 8 weeks.
- Women of child-bearing potential must have a negative pregnancy test before inclusion and agree to use highly effective contraception during the study (e.g., intrauterine device, bilateral tubal occlusion, vasectomized partner, or sexual abstinence).
- Avoid hormonal contraceptive methods due to risk of adverse events and liver function impairment.
You will not qualify if you...
- Other respiratory disorders such as current asthma diagnosis, early life asthma history before age 21, bronchiectasis, interstitial lung disease, or pulmonary eosinophilia.
- Use of long-term oxygen therapy or home non-invasive mechanical ventilation.
- Current smokers.
- Active cancer.
- Use of inhaled corticosteroids (ICS) within 3 months prior to recruitment.
- Participation in another randomized trial.
- Unlikely to complete the study.
- Pregnant or breastfeeding females.
- Exacerbations in the previous 8 weeks.
- Primary or secondary immunodeficiency.
- Immunosuppression or regular oral corticosteroid treatment.
- Allergy to investigational medicinal product excipients.
- Any condition assessed by the investigator as unsuitable for study participation.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Philips University of Marburg
Marburg, Germany
Actively Recruiting
2
Academisch Ziekenhuis Groningen
Groningen, Netherlands
Actively Recruiting
3
Clínic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
4
Son Espases
Palma de Mallorca, Spain, 07120
Actively Recruiting
5
University of Leicester
Leicester, United Kingdom
Not Yet Recruiting
6
Imperial College London
London, United Kingdom
Not Yet Recruiting
Research Team
R
Rosa Faner
CONTACT
M
Maria Joyera
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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