Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT07220928
Eligibility Criteria:
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, bronchiectasis) or cardiovascular disease
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07220928
Study Brief:
Protocol Section:
NCT07220928