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Набор скоро начнётся NCT07396311

Fractional Exhaled Nitric Oxide and Exacerbations of COPD

— Наблюдательное Chronic Obstructive Pulmonary Disease (COPD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention assigned.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: от 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Annualized rate of moderate-to-severe COPD exacerbations [Срок оценки: Up to 12 months after enrollment]
Вторичные конечные точки (2)
  • Change in lung function (FEV₁) [Срок оценки: Up to 12 months after enrollment]
  • Change in COPD Assessment Test (CAT) score [Срок оценки: Up to 12 months after enrollment]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Тайвань · 1 центр
  • Chang Gung Medical Foundation — Taoyuan

Публикации

  • Papi A, Romagnoli M, Baraldo S, Braccioni F, Guzzinati I, Saetta M, Ciaccia A, Fabbri LM. Partial reversibility of airflow limitation and increased exhaled NO and sputum eosinophilia in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Nov;162(5):1773-7. doi: 10.1164/ajrccm.162.5.9910112. PMID 11069811
  • Alcazar-Navarrete B, Ruiz Rodriguez O, Conde Baena P, Romero Palacios PJ, Agusti A. Persistently elevated exhaled nitric oxide fraction is associated with increased risk of exacerbation in COPD. Eur Respir J. 2018 Jan 18;51(1):1701457. doi: 10.1183/13993003.01457-2017. Print 2018 Jan. PMID 29348180
  • Zhou A, Zhou Z, Deng D, Zhao Y, Duan J, Cheng W, Liu C, Chen P. The Value of FENO Measurement for Predicting Treatment Response in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Sep 24;15:2257-2266. doi: 10.2147/COPD.S263673. eCollection 2020. PMID 33061343
  • Romero-Linares A, Alvarez-Muro L, Hammadi A, Hoyas-Sanchez C, Jimenez-Anton A, Almansa-Lopez A, Casares-Martin-Moreno L, Sanchez-Alvarez E, Murillo-Rodriguez A, Gomez-Mora M, Gomez-Pontes Cabrera T, Romero-Palacios PJ, Alcazar-Navarrete B. Short term exacerbation risk and exhaled nitric oxide in COPD. Respir Med. 2025 Jul;243:108134. doi: 10.1016/j.rmed.2025.108134. Epub 2025 Apr 30. PMID 40316031

Идентификаторы

NCT: NCT07396311 · 2512090251

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗