Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To evaluate the longitudinal stability of FeNO levels in COPD patients over a 12-month period with biannual measurements.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single Arm: Stable COPD Patients with Longitudinal FeNO and Blood Eosinophil Monitoring
Intervention: Blood eosinophil Count (Diagnostic Test)
Outcomes
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)
Secondary Outcomes
No secondary outcomes reported