CompletedNot Applicable

The Effect of a Cold Air Eucapnic Hyperventilation Test on Lower Respiratory Airways in Healthy Volunteers and Patients With Asthma

Belgium60 participantsStarted 2023-08-04

Plain-language summary

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an acute respiratory response in patients with asthma and in healthy subjects who have been exposed to high PM10 (unpublished data).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.

Who can participate

Age range18 Years – 65 Years

SexALL

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 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 Exclusion Criteria: * 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, …

What they're measuring

Proportional change in FEV1 after hyperventilation challenge

Timeframe: After each hyperventilation challenge: pre, immediately, 3, 5, 10, 15 and 30 minutes after the challenge

Trial details

NCT IDNCT07220928

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-27