Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD (BREATHE-COPD)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: COPD

Treatments: Diagnostic Test: Blood eosinophil Count

Study type: Interventional

Funder types: Other

Identifiers

NCT07045948

25213_BREATHE-COPD

Details and patient eligibility

About

This study aims to evaluate how airway inflammation, lung function, and symptoms change over time in people with chronic obstructive pulmonary disease (COPD). Airway inflammation will be assessed using a simple breath test (FeNO) and a small blood sample to measure eosinophils, a type of white blood cell. Participants will be followed for one year, with three study visits (at the start, 6 months, and 12 months). The goal is to understand how these markers evolve and whether they differ between people who experience a worsening of symptoms (called exacerbations) and those who remain stable. All tests except for a small extra blood draw are part of routine COPD care. Participation does not affect standard treatment.

Enrollment: 100 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged ≥ 40 years
• Diagnosed with COPD according to GOLD criteria
• Attending routine follow-up visits every 6 months
• Ability to provide informed consent

Exclusion criteria

• Recent respiratory tract infection or exacerbation (either moderate or se-vere) (<4 weeks before inclusion)
• Dominant asthmatic phenotype (ACO with asthma predominance)
• Severe comorbidities interfering with participation or follow-up

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Single Arm: Stable COPD Patients with Longitudinal FeNO and Blood Eosinophil Monitoring

Other group

Treatment:

Diagnostic Test: Blood eosinophil Count