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临床试验/NCT07261774
NCT07261774已完成不适用

The Impact of Extreme Heat Waves and Air Pollution on the Prognosis of Chronic Airway Diseases

Mersin University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年3月6日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Change in FeNO levels during extreme heat waves vs seasonal normal conditions

研究概览

简要总结

Extreme heat waves (EHW) and air pollution exacerbate chronic airway diseases, but little is known about how these environmental stressors affect quality of life, airway inflammation, symptom control, and pulmonary function. This study was designed to determine the impact of EHW and air pollution on asthma and COPD.

This was a prospective cohort study conducted among individuals with asthma and COPD in Mersin, Türkiye, between February 14 and December 1, 2024. Meteorological and air quality index (AQI) data were obtained from official sources. Participants underwent pulmonary function tests (PFTs) and fractional exhaled nitric oxide (FeNO) measurements during periods of normal weather conditions and repeated assessments during documented EHW periods. Patient-reported outcomes included the Asthma Control Test (ACT) and Asthma Quality of Life Questionnaire (AQLQ) for asthma, and the Modified Medical Research Council (mMRC) scale and COPD Assessment Test (CAT) for COPD. Exacerbation episodes requiring systemic corticosteroid use or hospitalization were also recorded.

The study aimed to evaluate the effects of EHW and air pollution on disease control, quality of life, lung function, airway inflammation, and exacerbation burden in patients with asthma and COPD.

详细描述

Climate change has led to a global increase in temperatures, and according to NASA, 2024 was the hottest year on record since 1850. Extreme heatwaves (EHW) represent one of the most significant manifestations of this crisis. While the adverse effects of air pollution on chronic respiratory diseases are well documented, the impact of extreme heatwaves on asthma and chronic obstructive pulmonary disease (COPD) has received less attention.

This study was designed to prospectively evaluate the effects of extreme heatwaves and air pollution on patients with asthma and COPD. The study was conducted in Mersin, Türkiye, between February and December 2024. Individuals with physician-diagnosed asthma or COPD who attended the outpatient clinic were enrolled.

Baseline assessments were performed on days with normal seasonal weather. Lung function was measured using spirometry, and airway inflammation was assessed using fractional exhaled nitric oxide (FeNO). Symptom control and quality of life were measured using validated questionnaires: the Asthma Control Test (ACT) and Asthma Quality of Life Questionnaire (AQLQ) for patients with asthma, and the Modified Medical Research Council (mMRC) scale and COPD Assessment Test (CAT) for patients with COPD.

Meteorological variables, including temperature, humidity, and wind, as well as daily air pollution levels, were obtained from official sources. On documented extreme heatwave days, participants were recalled for follow-up visits. At these visits, spirometry, FeNO, and questionnaire assessments were repeated. Information regarding exacerbation episodes requiring systemic corticosteroid use or hospitalization during the study period was also collected.

The study was designed to compare patient-level outcomes between normal weather days and extreme heatwave days. The overall objective was to investigate how environmental stressors such as heat and air pollution influence disease control, quality of life, symptoms, lung function, and airway inflammation in patients with asthma and COPD.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Provision of written informed consent
  • For the asthma group:
  • - Diagnosis of asthma for at least 6 months according to the GINA 2024 guidelines
  • Variable respiratory symptoms together with documented variable expiratory airflow limitation, demonstrated by at least one of the following:
  • Positive bronchodilator reversibility test (>12% and >200 mL increase in FEV1 10-15 minutes after 400 μg salbutamol)
  • Peak expiratory flow (PEF) variability (>10% average daily PEF variability over 2 weeks)
  • Positive delayed reversibility (improvement in lung function after 4 weeks of anti-inflammatory treatment with >12% and >200 mL increase in FEV1 or >20% increase in PEF)
  • Positive bronchial provocation test (≥20% fall in FEV1 with standard doses of methacholine or histamine)
  • Stable disease for at least 4 weeks prior to enrollment
  • For the COPD group:
  • Diagnosis of COPD for at least 6 months according to the GOLD 2024 guidelines (post-bronchodilator FEV1/FVC <70% in the presence of compatible clinical findings)
  • Stable disease for at least 4 weeks prior to enrollment

排除标准

  • Presence of other pulmonary diseases apart from asthma or COPD (e.g., interstitial lung diseases, pleural diseases, pulmonary vascular diseases)
  • Pregnant women
  • History of cancer within the past 5 years
  • Previous lung surgery
  • Active pulmonary tuberculosis
  • Respiratory tract infection within the last 4 weeks
  • Presence of significant extrapulmonary disease that may affect lung function (e.g., cerebrovascular disease, acute myocardial infarction)
  • Active smoking within the past year
  • Residence outside the central district of Mersin

结局指标

主要结局

Change in FeNO levels during extreme heat waves vs seasonal normal conditions

时间窗: Participants were evaluated twice over a 292-day period, from February 14, 2024, to December 1, 2024 (once during seasonal normal conditions and once during extreme heat waves).

Fractional exhaled nitric oxide (FeNO) (parts per billion (ppb)) measured using the Bedfont® NObreath device.

次要结局

  • Exacerbation frequency in asthma and COPD patients during extreme heat waves vs seasonal normal conditions(Participants were evaluated twice over a 292-day period, from February 14, 2024, to December 1, 2024 (once during seasonal normal conditions and once during extreme heat waves).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Naycı

Prof. Dr.

Mersin University

研究点 (1)

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