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AsthmaNCT07864506

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

A study of Asthma, run by University of Ontario Institute of Technology at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
Sep 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
  • For the control group: No asthma or other respiratory condition

Who cannot join

  • Does not meet all inclusion criteria
  • Parent or guardian does not provide consent when required

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Ontario Tech University

    Oshawa, Ontario

    Mika L Nonoyama, 416-813-7654 ext. 428064, mika.nonoyama@sickids.ca

Other trials in Canada

About this study

Official title: Testing the Effects of Temperature & Humidity on Children With and Without Asthmas in an Environmental Climatic Chamber

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:

Read more
  • 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.
Conditions
Asthma
Being tested
Controlled Temperature and Humidity Exposure
Keywords
asthma, children, lungs, environmental conditions, adolescents, temperature, spirometry, lung function, weather, humidity, respiratory
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Controlled Temperature and Humidity ExposureOther

    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 groups in NCT07864506
Study groupRoleWhat they receive
Asthma ArmExperimentalChildren and youth aged 11 to 18 years with asthma will be exposed to five controlled temperature and humidity conditions (ideal, cold dry, cold humid, hot dry, and hot humid) in a climatic chamber. Lung function, breathing symptoms, exercise capacity, and physiological responses will be measured before, during, and after each exposure.
Receives: Other: Controlled Temperature and Humidity Exposure
Non-asthma Control ArmActive comparatorAge- and sex-matched children and youth without asthma will undergo the same environmental exposures and assessments as the asthma group to allow comparison of responses between groups.
Receives: Other: Controlled Temperature and Humidity Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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 (34)
  1. Change in Peak Expiratory Flow (PEF)

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

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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.

  5. Respiratory Rate

    Respiratory rate will be continuously measured using the Zephyr BioHarness and Athena physiological system. Respiratory rate will be reported in breaths per minute.

    Measured: Continuously monitored beginning immediately prior to chamber entry and throughout each temperature and humidity exposure condition, including the washout periods. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

  6. Heart Rate Variability (HRV)

    HRV in milliseconds will be continuously measured using the Zephyr BioHarness and Athena platform to assess responses to temperature and humidity exposures.

    Measured: Continuously monitored beginning immediately prior to chamber entry and throughout each temperature and humidity exposure condition, including the washout periods. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

  7. Skin Temperature

    Skin temperature will be continuously measured using the Zephyr BioHarness and Athena physiological measurement platform. Skin temperature will be reported in degree Celsius.

    Measured: Continuously monitored beginning immediately prior to chamber entry and throughout each temperature and humidity exposure condition, including the washout periods. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

  8. Dyspnea

    Dyspnea will be assessed using the Modified Borg Scale (no units).

    Measured: Measured 1-5 minutes before entering the chamber, immediately after chamber entry, 1-5 minutes before/after the mCAFT, and after each temperature and humidity exposure. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

  9. Blood Pressure

    Blood pressure will be measured before and after the modified Canadian Aerobic Fitness Test using a blood pressure monitor. Blood pressure will be reported in mmHg.

    Measured: Measured at the beginning and end of each study visit and within 1-5 minutes before and after mCAFT during each temperature and humidity exposure. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

  10. Peripheral oxygen saturation (SpO2)

    SpO2 will be measured using a fingertip pulse oximeter (Masimo MightySat or Rad-G).

    Measured: Measured during mCAFT within each temperature and humidity exposure condition. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

  11. Rate of Perceived Exertion (RPE)

    RPE will be assessed using Borg 6-20 scale. RPE will be reported as a score from 6-20.

    Measured: Assessed 1- 5 minutes before and 1- 5 minutes after mCAFT testing. Conditions are separated by a 45-minute washout and repeated across 2 study visits.

  12. Change in Estimated Peak Oxygen Uptake (VO₂peak) as Measured by the Modified Canadian Aerobic Fitness Test (mCAFT)

    The Modified Canadian Aerobic Fitness Test (mCAFT) will be used to measure exercise capacity. It is a progressive submaximal step test used to estimate peak oxygen uptake (VO₂peak). Participants will complete 3-minute stepping stages of increasing intensity, with cadence and step height adjusted according to age and sex. Estimated peak oxygen uptake (VO₂peak) will be calculated and reported in mL/kg/min.

    Measured: Measured during the mCAFT within each temperature and humidity exposure condition. Assessments are repeated across two study visits approximately 2 weeks apart, with a 45-minute washout between conditions.

  13. Change in Maximum Stage Achieved on the Modified Canadian Aerobic Fitness Test (mCAFT)

    The Modified Canadian Aerobic Fitness Test (mCAFT) will be used to measure exercise capacity. It is a progressive submaximal step test consisting of 3-minute stepping stages of increasing intensity, with cadence and step height adjusted according to age and sex. The maximum stage successfully completed by each participant will be recorded.

    Measured: Measured during the Modified Canadian Aerobic Fitness Test (mCAFT) within each temperature and humidity exposure condition. Assessments are repeated across two study visits approximately 2 weeks apart, with a 45-minute washout between conditions.

  14. Respiratory Medications Used Prior to Testing

    Respiratory medications used prior to each temperature and humidity exposure condition, including medication name, dose, and time of administration.

    Measured: Recorded prior to each temperature and humidity exposure condition (ideal, cold-dry, cold-humid, hot-dry, and hot-humid) across 2 study visits.

  15. Exposure Duration

    Duration of completion of each temperature and humidity exposure condition, calculated as time between chamber entry and chamber exit. Measured in minutes.

    Measured: Measured during each exposure condition (ideal, cold-dry, cold-humid, hot-dry, and hot-humid) across 2 study visits.

  16. Actions Taken in the Chamber

    Actions taken during/after each temperature and humidity exposure condition, including rescue respiratory medication use, cooling chair use, provision of coverings (e.g., blankets), early exit from the chamber, and other exposure-related will be noted down by study staff.

    Measured: Measured during/after each temperature and humidity exposure condition (ideal, cold-dry, cold-humid, hot-dry, and hot-humid) across 2 study visits.

  17. Participant Age

    Participant age will be collected and reported in years.

    Measured: Measured once during screening and baseline assessments on Day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  18. Sex at Birth

    Participant reported sex assigned at birth will be collected and reported as categorical options.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  19. Gender Identity

    Participant reported gender identity will be collected and reported as categorical options.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  20. Years Since Asthma Diagnosis

    Time since diagnosed asthma will be collected and reported in years.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  21. Asthma Triggers

    Participant asthma triggers, including allergic and non-allergic triggers, will be collected and reported as categorical options and free text.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  22. Height

    Participant height will be measured and reported in meters (m).

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  23. Weight

    Participant weight will be measured and reported in kilograms (kg).

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  24. Respiratory Medication Use

    Current respiratory medication use reported as categorical options and free text.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  25. Body Mass Index (BMI)

    BMI will be calculated from height (m) and weight (kg) and reported in kg/m².

    Measured: Calculated once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  26. Co-Morbidities

    Participant reported co-morbid medical conditions will be collected and reported as categorical response options and free text.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  27. Other Medical Diagnoses

    Participant reported medical diagnoses other than asthma will be collected and reported as free text.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  28. Ethnicity

    Participant reported ethnicity will be collected and reported as categorical options.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  29. Social Determinants of Health

    Social determinants of health, including factors that may influence health outcomes and healthcare access, will be collected and reported as questionnaire responses.

    Measured: Measured once during screening and baseline assessments on day 1 (pre-test), prior to any temperature and humidity exposure conditions.

  30. Asthma Control Test (ACT)

    Asthma control will be assessed using the ACT, a validated questionnaire that evaluates asthma symptoms, activity limitations, and overall control. Scores range from 5 to 25, with higher scores indicating better asthma control. The ACT will be used to assess changes in asthma control status throughout study participation.

    Measured: Measured at screening/baseline prior to the exposure sessions.

  31. Physical Activity Questionnaire for Older Children (PAQ-C)

    The PAQ-C is a self-administered questionnaire that assesses a child's general physical activity level during the previous 7 days. Higher scores indicate greater physical activity.

    Measured: Measured at baseline prior to the exposures.

  32. Physical Activity Questionnaire for Adolescents (PAQ-A)

    The PAQ-A is a self-administered questionnaire that assesses an adolescent's general physical activity level during the previous 7 days. Higher scores indicate greater physical activity.

    Measured: Measured at baseline prior to exposures.

  33. Mini Pediatrics Asthma Quality of Life Questionnaire (MiniPAQLQ)

    The miniPAQLQ is a self-administered questionnaire that assess asthma-related quality of life in children, including symptoms, activity limitations and emotional function. Higher scores indicate better quality of life.

    Measured: Measured at baseline prior to exposures.

  34. International Study of Asthma & Allergies in Childhood (ISAAC) Core Questionnaire for Asthma

    The ISAAC Core Questionnaire for Asthma will be used to assess asthma symptoms and history in control participants to confirm the absence of asthma and other respiratory conditions.

    Measured: Measured at baseline prior to exposures.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07864506
Sponsor's protocol ID
AsthmaACE
Other IDs
2025-26CERA-00000000007
Status last verified
Oct 2026
First submitted
12 Sep 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study of Asthma, run by University of Ontario Institute of Technology at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mika L Nonoyama (905-721-8668 ext. 5329, mika.nonoyama@ontariotechu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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