Studies biological markers of response to inhaled steroid in COPD patients
Tests budesonide in former smokers with COPD, stratified by eosinophil levels.
Plain-language title generated from the registry record
Registry title: Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Key facts
- Where
- Marburg, GermanySee the site
- Phase
- Phase 4
Where in Germany
- Philips University of MarburgMarburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maria Joyera Rodríguez
- Trial code
- NCT06334575
- Record updated
- 20 July 2026
- Original description
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 microbiomeRead full original descriptionShow less
Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
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
Inclusion: 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.
Exclusion: 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); Long-term oxygen therapy or non-invasive mechanical ventilation at home; Use of ICS in the 3 months prior to the recruitment; Exacerbations in the previous 8 weeks; Immunosuppression or regular oral corticosteroid treatment; Active cancer; Allergy to IMP's excipients; Current smokers; 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.