Testing the Effects of Temperature & Humidity on Children With and Without Asthma in an Environmental Climatic Chamber

Condition(s) studied

Investigational drug(s) / intervention(s)

Controlled Temperature and Humidity Exposure: Exposure to five controlled environmental conditions in a climatic chamber: ideal (18°C, 50-60% RH), cold dry (-15°C, 30-40% RH), cold humid (-15°C, 95-100% RH), hot dry (+35°C, 30-40% RH), and hot humid (+35°C, 95-100% RH). Participants undergo lung function testing, exercise testing, symptom assessments, and physiological monitoring during and after exposures.

Study summary

The goal of this clinical study is to learn how different temperature and humidity conditions affect breathing, lung function, exercise capacity, symptoms, and other physical responses in children and youth aged 11 to 18 years with asthma, compared with age- and sex-matched children and youth without asthma.

The main questions it aims to answer are:

* How do different temperature and humidity conditions affect lung function, breathing symptoms, exercise capacity, and physiological responses in children and youth with asthma?
* Do children and youth with asthma respond differently to these environmental conditions than children and youth without asthma?
* Do sex and gender influence these responses?

Researchers will compare children and youth with asthma to age- and sex-matched children and youth without asthma to see if temperature and humidity exposures have different effects on breathing, exercise performance, symptoms, and physiological responses.

Participants will:

* Attend two study visits in a climate-controlled chamber.
* Be exposed to hot, cold, and varying humidity conditions for short periods of time.
* Complete breathing tests and exercise testing before, during, and after each exposure.
* Have symptoms, physical activity, and physiological responses monitored throughout the study.

Eligibility

Primary outcome measure(s)

• Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) — Measured 1-5 min before entering each temperature/humidity condition, 1-5 min after entering the chamber, and 1-5 min after mCAFT. Day 1 is ~2 weeks after enrollment; Day 2 ~2 weeks later. Conditions are separated by 45 min washout.
  Spirometry will be performed using the In2itive™ (Vitalograph, UK) to assess lung function. FEV1 in mL will be used to evaluate the effects of different temperature and humidity exposures.
• Change in Forced Vital Capacity (FVC) — Measured 1-5 min before entering each temperature/humidity condition, 1-5 min after entering the chamber, and 1-5 min after mCAFT. Day 1 is ~2 weeks after enrollment; Day 2 ~2 weeks later. Conditions are separated by 45 min washout.
  FVC in mL will be measured using the In2itive™ (Vitalograph, UK) to assess lung function.

Trial sites (1)

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