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:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT06126692
Eligibility Criteria:
Inclusion Criteria:
* Patients with severe asthma that requires High dose ICS (corresponding to minimum 1600 micrograms Budesonide per day) + either LABA, LTRA, or LAMA OR Fixed Prednisolone treatment (OCS) minimum 50% of the time. Minimum 2 exacerbations in the last year or fixed Prednisolone treatment (OCS) minimum 50% of the time OR ACQ\>1.5 AND Fulfils national criteria for specific biologic treatment.
* Patients with mild/moderate asthma that requires Low/Medium dose of ICS/LABA +/- LTRA. ACQ \< 1.5. No exacerbations in the last year or need of Prednisolone treatment (OCS). Markers of T2 inflammation (B-eos ≥ 0.15 actual or ≥ 0.30 the last year or Sputum eos ≥ 3%, FeNO ≥ 25, allergens positivity). Not direct candidate for treatments with monoclonal antibodies.
* Healthy volunteers that reports no respiratory diseases, No history of asthma or respiratory symptoms, normal lung function. No history of allergies. No lower or upper respiratory infections in the past 4 weeks.
Exclusion Criteria:
* Patients with severe asthma:
1. Known hypersensitivity to the active substance or any of the excipients
2. Participation in an interventional clinical trial within 3 months of visit 1 or receipt of any investigational medicinal product within 3 months or 5 half-lives. Participation in other observational studies is acceptable if in the view of the investigator it will not impact on the study outcomes.
3. Other clinically significant medical disease or uncontrolled concomitant disease that is likely, in the opinion of the investigator, to require a change in therapy or impact the ability to participate in the study.
* Patients with mild/moderate asthma:
1. Unable to understand written information due to language barriers.
2. Unable to give informed consent, i.e., patients who are incapable.
3. Show sign of symptoms of uncontrolled asthma (ACQ score higher than 1.5, OCS use, history of exacerbations within the past year).
* Healthy volunteers:
1. Unable to understand written information due to language barriers.
2. Unable to give informed consent, i.e., patients who are incapable.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06126692
Study Brief:
Protocol Section:
NCT06126692