Status:
COMPLETED
The Effect of a Cold Air Eucapnic Hyperventilation Test on Lower Respiratory Airways in Healthy Volunteers and Patients With Asthma
Lead Sponsor:
KU Leuven
Collaborating Sponsors:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Asthma (Diagnosis)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 typ...
Detailed Description
In this study, we aim to develop a safe and feasible cold air (-15°C) eucapnic hyperventilation (CAEH) test protocol in which we can compare the lower airway responses between healthy volunteers and s...
Eligibility Criteria
Inclusion
- 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
- 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
- Pregnancy
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07220928
Start Date
August 4 2023
End Date
November 27 2024
Last Update
October 24 2025
Active Locations (1)
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1
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000