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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location status: Recruiting

Location contact

Naomi Michotte, MD

CONTACT

[email protected]

+3224776841

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood eosinophil count

Diagnostic Test

Blood sample for blood eosinophil count

Primary outcomes

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Naomi Michotte, MD

CONTACT

[email protected]

024776841

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Acronym: BREATHE-COPD

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Jul 1, 2025
Registry last updated: Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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