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NCT Number: NCT07396311

Fractional Exhaled Nitric Oxide and Exacerbations of COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (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

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 40 years or older
  • Diagnosis of chronic obstructive pulmonary disease (COPD) confirmed by post-bronchodilator spirometry (FEV₁/FVC < 0.70).
  • History of cigarette smoking
  • Receiving triple inhaler therapy (inhaled corticosteroid/long-acting beta-agonist/long-acting muscarinic antagonist) as part of routine clinical care, including:
  • patients who have been previously escalated to triple inhaler therapy due to prior exacerbations and are already receiving triple therapy at the time of enrollment, and
  • patients who are newly prescribed triple inhaler therapy at or immediately before enrollment because of a recent exacerbation.

Exclusion criteria

-

Treatment and study plan

No intervention assigned

Other

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.

Primary outcomes

  1. Annualized rate of moderate-to-severe COPD exacerbations

    Time frame: Up to 12 months after enrollment

    Moderate exacerbations are defined as those requiring systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as those requiring hospitalization or emergency department visits lasting more than 24 hours.

Secondary outcomes

  1. Change in lung function (FEV₁)

    Time frame: Up to 12 months after enrollment

    Rate of decline in pre-bronchodilator FEV₁

  2. Change in COPD Assessment Test (CAT) score

    Time frame: Up to 12 months after enrollment

    Change in symptom burden assessed by CAT

Other outcomes

  1. Multimarker and Environmental Interaction

    Time frame: up to 12 months

    Multivariable negative binomial models will include FeNO (spline + categories), eosinophils (<100, 100-<300, ≥300 cells/µL), IgE (log-transformed), and air pollutants (PM10, PM2.5, NO2, SO2, CO, and O3; levels of baseline, 1-month, 6-month, and 1-year follow-up). FeNO-specific adjusted IRRs and predicted rates at 15, 20, 25, 35, and 50 ppb will be presented. Significant interactions (FeNO×smoking, FeNO×ICS dose, FeNO×PM₂.₅ quartiles) will be visualized with stratum-specific curves.

    This analysis will determine whether FeNO remains a consistent predictor across different inflammatory or environmental contexts, or whether its predictive value varies depending on eosinophil counts, smoking status, or air pollution exposure.

Study contacts

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

Ting-Yu Lin, MD

CONTACT

[email protected]

+886-3-3281200 ext. 8468

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

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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