The Impact of Extreme Heat Waves and Air Pollution on the Prognosis of Chronic Airway Diseases
NCT ID: NCT07261774
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
96 participants
OBSERVATIONAL
2024-03-06
2024-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asthma Group
Patients with physician-diagnosed asthma who met the inclusion criteria and were followed during periods of extreme heat waves and normal seasonal weather.
No interventions assigned to this group
COPD Group
Patients with physician-diagnosed chronic obstructive pulmonary disease (COPD) who met the inclusion criteria and were followed during periods of extreme heat waves and normal seasonal weather.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Mersin University
OTHER
Responsible Party
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Sibel Naycı
Prof. Dr.
Locations
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Mersin University Faculty of Medicin
Mersin, Mersin, Turkey (Türkiye)
Countries
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Other Identifiers
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MU-2024/097
Identifier Type: -
Identifier Source: org_study_id
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