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Taking people in GermanyPhase 4

Studying how inhaled steroids act in COPD by blood eosinophil level

Tests inhaled steroids in adults with COPD, grouped by blood eosinophil levels.

Key facts

Who runs it
Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer
Where
Marburg, GermanySee the siteAlso in 2 other countries, 3 sites
Registry title
Molecular signatures associated with response to ICS treatment in patients with COPD stratified by eosinophil levels
Status
Recruiting
Phase
Phase 4
People taking part
60 people, planned
Started
12 Feb 2025
Planned end
31 Dec 2025
Type of study
Interventional
Record updated
11 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Allergy to IMP’s excipients
  • Active cancer
  • Blood eosinophil count <100 eos/mcL
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 64 years old?

Where in Germany

Also in 2 other countries, 3 sites

  • Philipps-Universitaet MarburgMarburg, GermanyTaking people

About the trial

What the trial wants to find out

To determine the molecular changes associated with the use of ICS in COPD patients with different blood eosinophil counts.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Molecular signatures associated with response to ICS treatment in patients with COPD stratified by eosinophil levels
Plain-language title
Studying how inhaled steroids act in COPD by blood eosinophil levelGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Fit questions
Built from 2023-505245-13-00, who can take part
Record updated
11 January 2026