The Impact of Extreme Heat Waves and Air Pollution on the Prognosis of Chronic Airway Diseases (NCT07261774) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Extreme Heat Waves and Air Pollution on the Prognosis of Chronic Airway Diseases
Turkey (Türkiye)96 participantsStarted 2024-03-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 extrapu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in FeNO levels during extreme heat waves vs seasonal normal conditions
Timeframe: 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).