Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD

NCT ID: NCT07045948

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2028-06-30

Brief Summary

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Blood eosinophil Count

Intervention Type: DIAGNOSTIC_TEST

Blood sample for blood eosinophil count

Interventions

Blood eosinophil Count

Blood sample for blood eosinophil count

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Naomi Michotte, MD

Role: CONTACT

pneumologie@uzbrussel.be

024776841

Facility Contacts

Naomi Michotte, MD

Role: primary

pneumologie@uzbrussel.be

+3224776841

Other Identifiers

25213_BREATHE-COPD

Identifier Type: -

Identifier Source: org_study_id