Health TrialsbyHealthPanel

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

ConditionAsthma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-18
SponsorUniversity of Ontario Institute of Technology

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Children and youth aged 11 to 18 years

Able to provide assent/consent, with parent or guardian consent when required

Diagnosed with asthma and currently stable (for the asthma group)

Willing to attend study visits at the ACE research facility in Oshawa, Ontario

Disqualifiers

Does not meet all inclusion criteria

Parent or guardian does not provide consent when required

Trial design

Design model

Crossover

Treatments tested in this trial

  • Controlled Temperature and Humidity Exposure

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Asthma ArmExperimental treatment 1 intervention
Group B: Non-asthma Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)

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.

Time frame
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.
2

Change in Forced Vital Capacity (FVC)

FVC in mL will be measured using the In2itive™ (Vitalograph, UK) to assess lung function.

Time frame
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.

Secondary outcomes

1

Change in Peak Expiratory Flow (PEF)

PEF in L/min will be measured using the In2itive™ (Vitalograph, UK) to assess lung function.

Time frame
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.
2

Change in FEV1/FVC Ratio

The FEV1/FVC ratio (%) will be calculated from spirometry measurements using the In2itive™ (Vitalograph, UK) to assess airflow limitation.

Time frame
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.
3

Airway inflammation

Fractional exhaled nitric oxide (FeNO) will be measured using the NIOX VERO device as a non-invasive biomarker of airway inflammation, measured in parts per billion (ppb).

Time frame
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.
4

Heart Rate

Heart rate will be continuously measured using the Zephyr BioHarness and Athena physiological measurement system. Heart rate will be reported in beats per minute (bpm).

Time frame
Continuously monitored beginning prior to chamber entry and throughout each temperature and humidity exposure condition, including pre-, during, and post-mCAFT. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ontario Institute of Technology

Lead sponsor

The Hospital for Sick Children

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: