NCT06334575

Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Maria Joyera Rodríguez · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Budesonide	receive, on top of their usual treatment Budesonide dry powder inhaler, 400 mcg/12 hours for 8 weeks

Timeline

• Start date: 2025-02-12
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-03-28
• Last updated: 2026-03-05

Locations

6 sites across 4 countries: Germany, Netherlands, Spain, United Kingdom