COPDBREATHE-COPDNCT07045948
Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD
A study testing Blood eosinophil Count in people with COPD, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Blood eosinophil Count
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Jul 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥ 40 years
- Diagnosed with COPD according to GOLD criteria
- Attending routine follow-up visits every 6 months
- Ability to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, 1090
Naomi Michotte, MD, +3224776841, pneumologie@uzbrussel.be
About this study
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
- Being tested
- Blood eosinophil Count
- Keywords
- FeNO, Blood eosinophil count, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood eosinophil CountDiagnostic test
Blood sample for blood eosinophil count
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Stable COPD Patients with Longitudinal FeNO and Blood Eosinophil Monitoring | Other | Not described Receives: Diagnostic Test: Blood eosinophil Count |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the longitudinal stability of FeNO levels in COPD patients over a 12-month period with biannual measurements.
Measured: from enrollment to the end of the study period (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start14 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045948
- Sponsor's protocol ID
- 25213_BREATHE-COPD
- Acronym
- BREATHE-COPD
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD
- ClinicalTrials.gov ID
- NCT07045948
- Acronym / sponsor ID
- BREATHE-COPD / 25213_BREATHE-COPD
- Conditions
- COPD
- Keywords
- FeNO, Blood eosinophil count, COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Stable COPD Patients with Longitudinal FeNO and Blood Eosinophil Monitoring | Other | Diagnostic Test: Blood eosinophil Count |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥ 40 years
- Diagnosed with COPD according to GOLD criteria
- Attending routine follow-up visits every 6 months
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood eosinophil CountBlood sample for blood eosinophil count | Diagnostic test | Single Arm: Stable COPD Patients with Longitudinal FeNO and Blood Eosinophil Monitoring |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood eosinophil Count in people with COPD, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi Michotte, MD (024776841, pneumologie@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.