NCT07220928Completed
The Effect of a Cold Air Eucapnic Hyperventilation Test on Lower Respiratory Airways in Healthy Volunteers and Patients With Asthma
Source: ClinicalTrials.gov · Last updated 24 Oct 2025
Brief summary (registry, in English)
In this study, we want to evaluate the feasibility and safety of a CAEH test in healthy volunteers and patients with asthma. We want to develop a CAEH test to differentiate patients with different types of asthma and exercise-induced bronchoconstriction from healthy volunteers and to evaluate whether the respiratory phenotype induced by cold air inhalation differs between subjects with asthma and healthy subjects. Furthermore, we want to evaluate whether the CAEH test is more robust over time compared to the EVH test. Previously, our lab has demonstrated that submaximal exercise at subfreezing temperatures in a climate chamber (-5°C) induces an acute respiratory response in patients with asthma and in healthy subjects who have been exposed to high PM10 (unpublished data). Finally, This study will serve as a preliminary study for a subsequent prospective study in which the results and optimized protocol obtained in this study will be used to further evaluate the feasibility of using this CAEH as a diagnostic tool in asthma compared to EIB (CLARINET2). The present study is required to develop a standardized CAEH test in a safe and feasible manner. This study will also help to identify appropriate endpoints (FEV1, multiple breath washout test, biomarkers…) of the subsequent studies.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 23 Oct 2025
- Start date
- 4 Aug 2023
- Primary completion date
- 27 Nov 2024
- Lead sponsor
- KU Leuven
- Diseases
- Asthma
- NCT number
- NCT07220928
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 4 Aug 2023 to the primary completion date, 27 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of intubation or admission to ICU due to asthma
- Severe asthma exacerbation within one month prior to screening visit
- Treatment with oral or systemic steroids within one month prior to screening visit
- Previous treatment with biologics for asthma
- Other major concurrent pulmonary (such as COPD, cystic fibrosis, sarcoidosis, interstitial lung disease, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, bronchiectasis) or cardiovascular disease
Other
- Pregnancy
Who the study is looking for
- Age between 18 and 65 years old at time of signing informed consent
- BMI between 18 and 28 kg/cm2
- Ability to give informed consent and to comply with study protocol, in the investigator's judgement
- Non-smoking or ex-smokers for at least 12 months with less than 10 pack years
- Normal spirometry
- Group specific:
- Histamine positive healthy controls: histamine bronchial challenge test (\< 8 mg/ml) at screening Healthy controls: histamine bronchial challenge test (≥ 8 mg/ml) at screening
- Patients with asthma:
- Physician-diagnosed asthma for at least 6 months
- Post-bronchodilator FEV1 of ≥ 80% at screening
- Documented airway reversibility either by means of post-bronchodilator reversibility of ≥ 12.% and ≥ 200 ml or in the previous 6 months or by means of documented airway hyperresponsiveness (histamine PC20 \< 4 mg/ml) at screening
- Asthma control questionnaire (ACQ) ≤ 1.5
- Regular treatment with ICS with or without LABA (unchanged dose for at least 30 days) at a low or medium dose of ICS
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.