Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels
NCT06334575 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 135
Last updated 2026-03-05
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
Conditions
Interventions
- DRUG
-
Budesonide
receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks
Sponsors & Collaborators
-
Maria Joyera Rodríguez
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-12
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Germany
- Netherlands
- Spain
- United Kingdom
Study Locations
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