Fractional Exhaled Nitric Oxide (FeNO) as a Predictor of Exacerbations in COPD Patients Initiated on Triple Inhaler Therapy: A Prospective Exploratory Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Annualized rate of moderate-to-severe COPD exacerbations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
COPD Patients Initiated on Triple Inhaler Therapy
This cohort includes patients with chronic obstructive pulmonary disease (COPD) receiving triple inhaler therapy (inhaled corticosteroid/long-acting beta-agonist/long-acting muscarinic antagonist) as part of routine clinical care following one or more recent exacerbations. Eligible participants include both patients who have been escalated to triple therapy due to prior exacerbations and are already receiving triple therapy at enrollment, as well as patients who are newly prescribed triple therapy at or immediately before enrollment because of a recent exacerbation. All participants are followed prospectively for up to 12 months to assess exacerbations, lung function, symptoms, and inflammatory biomarkers. Baseline fractional exhaled nitric oxide (FeNO) is evaluated as a predictor of clinical outcomes.
干预措施: No intervention assigned (Other)
结局指标
主要结局
Annualized rate of moderate-to-severe COPD exacerbations
时间窗: 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.
次要结局
- Change in lung function (FEV₁)(Up to 12 months after enrollment)
- Change in COPD Assessment Test (CAT) score(Up to 12 months after enrollment)