NCT07396311

Fractional Exhaled Nitric Oxide and Exacerbations of COPD

Fractional Exhaled Nitric Oxide (FeNO) as a Predictor of Exacerbations in COPD Patients Initiated on Triple Inhaler Therapy: A Prospective Exploratory Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition with recurrent exacerbations despite guideline-based therapy. This prospective observational cohort study aims to evaluate whether baseline fractional exhaled nitric oxide (FeNO), a biomarker of type 2 airway inflammation, predicts future exacerbations and lung function decline in COPD patients initiated on triple inhaler therapy in routine clinical practice. The study will also explore the relationships between air pollution exposure, type 2 inflammatory biomarkers, and COPD outcomes.

Detailed description

This is a pragmatic, prospective, longitudinal observational cohort study conducted in patients with COPD who are initiated on triple inhaler therapy as part of routine clinical care. No investigational drugs, devices, or protocol-mandated interventions are administered. Biomarker measurements, including fractional exhaled nitric oxide (FeNO), are performed for research purposes only and do not influence clinical decision-making. Participants will be followed for up to 12 months after enrollment with scheduled assessments of exacerbation events, lung function, symptom burden, and biomarkers. The total study duration is approximately 24 months, accounting for a 12-month enrollment period and completion of follow-up for the last enrolled participant. Environmental air pollution exposure will be estimated using a validated hybrid kriging/land-use regression model based on residential address.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
OTHER	No intervention assigned	No investigational intervention is assigned in this observational study. All treatments, including triple inhaler therapy, are prescribed at the discretion of the treating physicians as part of routine clinical care. The research team does not assign, modify, or mandate any therapeutic intervention.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-02-29
• Completion: 2028-02-29
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Taiwan