Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
Condition(s) studied
Investigational drug(s) / intervention(s)
Budesonide: receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks
Study 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
Primary outcome measure(s)
- Significant molecular changes in COPD stratified by their blood eosinophil counts. — 8 weeks
Significant molecular changes (p\<0.05, and/or FDR\<0.05) (e.g. microbiome and/or transcriptome and/or proteins and/or epigenetics) in sputum, nasal and oropharyngeal swabs, urine and/or blood associated with ICS treatment vs. no ICS treatment (usual care), in COPD stratified by their blood eosinophil counts.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Philips University of Marburg | Marburg | Germany | Recruiting |
| Academisch Ziekenhuis Groningen | Groningen | Netherlands | Recruiting |
| Clínic Barcelona | Barcelona | Spain | Recruiting |
| Son Espases | Palma de Mallorca | Spain | Recruiting |
| University of Leicester | Leicester | United Kingdom | Not Yet Recruiting |
| Imperial College London | London | United Kingdom | Not Yet Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06334575 on ClinicalTrials.gov ↗ ← All trials in the Netherlands