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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05919394
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 and 80 years of age diagnosed of uncontrolled asthma.
* T2 high asthma: \> 300 cels/mm3 blood Eos (current value) or 150 cels/mm3 blood Eos (current value) and a historical value ≥ 300 cels/mm3 or FENO ≥ 25 ppb (current value).
* Uncontrolled asthma, this is, ACT \<20 and/or \> 1 of an exacerbation in the last 12 months, despite treatment with ICS/LABA at medium dose.
* Written informed consent.
Exclusion Criteria:
* Patients who refuse to sign the informed consent form.
* Medical situation that prevents the collection of study information.
* Diagnosis of severe uncontrolled asthma established with criteria other than those established (ACT \<20 and/or \> 1 exacerbation in the last 12 months, despite treatment with ICS / LABA at medium dose).
* Medical or administrative situation that prevents the patient from following up to a minimum of 52 weeks.
* Treatment with high dose ICS/LABA, LAMA, systemic corticosteroid, azithromycin, monoclonal antibody.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05919394
Study Brief:
Protocol Section:
NCT05919394