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

NCT07045948 | Recruiting DMC

• 1 other identifier: 25213_BREATHE-COPD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

FeNO; Blood eosinophil count; COPD

Outcome Measures

Primary Outcomes (1)

• To evaluate the longitudinal stability of FeNO levels in COPD patients over a 12-month period with biannual measurements.

  from enrollment to the end of the study period (1 year)

Study Arms (1)

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

OTHER

Diagnostic Test: Blood eosinophil Count

Interventions

Blood eosinophil Count DIAGNOSTIC_TEST

Blood sample for blood eosinophil count

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dominant asthmatic phenotype (ACO with asthma predominance)
• Severe comorbidities interfering with participation or follow-up

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Naomi Michotte, MD

CONTACT

024776841; pneumologie@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-06

Locations

BE (1)