2023-505245-13-00RecruitingPhase 4
Molecular signatures associated with response to ICS treatment in patients with COPD stratified by eosinophil levels
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Jan 2026
Brief summary (registry, in English)
To determine the molecular changes associated with the use of ICS in COPD patients with different blood eosinophil counts.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Mar 2024
- Start date
- 12 Feb 2025
- Lead sponsor
- Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
- Diseases
- COPD
- EU CT number
- 2023-505245-13-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men and women with mild to moderate COPD who already use two long-acting bronchodilators and are former smokers. It studies molecular changes linked to inhaled corticosteroid (ICS) treatment at different blood eosinophil counts.
- Age
- 40 years or older (the registry also lists 18 to 64 years).
- Sex
- Men and women can join.
- Disease stage
- Mild to moderate COPD: post-bronchodilator FEV1/FVC below 0.70 and FEV1 of at least 30.
- Earlier treatment
- Must have used two long-acting bronchodilators (LABA+LAMA) regularly for at least 8 weeks. Must not have used ICS in the 3 months before joining.
- Biomarker or test result
- Blood eosinophil count of at least 100 eos/mcL.
Main reasons for not taking part
- Other lung diseases such as asthma, bronchiectasis or interstitial lung disease
- Current smokers
- Flare-up (exacerbation) in the last 8 weeks
- Regular oral corticosteroids or a weakened immune system
- Pregnant or breastfeeding women
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of other respiratory disorders, (i.e. current physician diagnosis of asthma, early life history of asthma (<21 years) a previous clinical diagnosis of bronchiectasis, interstitial lung disease, pulmonary eosinophilia).
- Exacerbations in the previous 8 weeks.
- Immunosuppression or regular oral corticosteroid treatment.
- Long-term oxygen therapy or non-invasive mechanical ventilation at home.
- Use of ICS in the 3 months prior to the recruitment.
Other illness
- Allergy to IMP’s excipients.
- Active cancer.
Lab values
- Blood eosinophil count <100 eos/mcL
Other
- Participating in another randomized trial.
- Not likely to complete the study.
- Pregnant or breastfeeding females.
- Primary or secondary immunodeficiency.
- Any circumstances which could contradict study participation and lead the investigator to assess the patient as unsuitable for study participation for any other reason.
- Current smokers.
Who the study is looking for
- Male and female patients ≥40 years of age.
- ≥ 10 pack-years smoking.
- Former smokers (≥6 months).
- post-bronchodilator FEV1/FVC<0.70.
- FEV1 ≥30 (i.e. mild-moderated COPD patients).
- Signed written informed consent form.
- On regular treatment with dual long-acting bronchodilators (LABA+LAMA), minimum 8 weeks of usage.
- Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.
- Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Philipps-Universitaet Marburg | Marburg | Germany | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| University Hospital Son Espases | Palma | Spain | Recruiting |
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.