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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-06

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma (Diagnosis) COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Sibel Naycı

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mersin University Faculty of Medicin

Mersin, Mersin, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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MU-2024/097

Identifier Type: -

Identifier Source: org_study_id

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