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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT04612556
Eligibility Criteria:
Inclusion Criteria:
Key inclusion criteria
* Written informed consent must be obtained at screening visit, before any assessment will be performed. Subjects should be able to provide informed written consent (study participation informed consent form): Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
* Confirmed asthma diagnosis and severity and treatment requirements.
* Fixed airway obstruction (FAO) where post-bronchodilator treatment ratio of forced expiratory volume in 1 second \[FEV1\] to forced vital capacity \[FVC\] is below \< 70%.
* Confirmed optimized management skills (inhaler technique, education, adherence)
* Triggers and relevant co-morbidity have been assessed and managed Triggers such as smoking, beta-blockers, aspirin/NSAIDs, allergen exposure; Comorbidities such as rhinitis, obesity, GERD, OSA, VCD, depression/anxiety.
* Severe asthmatics with blood eosinophils ≥150cells/ul at screening visit or ≥300cells/ul the last 12 months.
* Patients with late-onset severe according to ERS/ATS guidelines eosinophilic asthma and fixed obstruction under the treatment of high dose of ICS+LABA±LAMA (late-onset asthma determined as age at diagnosis from 20 years and above)
* Patients with late-onset severe eosinophilic asthma with history ≥ 1 exacerbation the previous year under the treatment of high dose of ICS+LABA±LAMA.
* Asthma Exacerbation: Subjects with an ongoing asthma exacerbation should have their screening and treatment initiation visit delayed until the investigator considers the subject has returned to their baseline asthma status. If the 4-week screening period has elapsed then the subject should be considered a screening failure. An exacerbation is defined as worsening of asthma requiring the use of systemic corticosteroids and/or emergency department visit, or hospitalization. For subjects on maintenance oral corticosteroids, an exacerbation requiring oral corticosteroids was defined as the use of oral/systemic corticosteroids at least double the existing dose for at least 3 days.
* Maintenance Asthma Therapy: No changes in the dose or regimen of baseline ICS and/or additional controller medication during the screening period (except for treatment of an exacerbation).
* Meet requirements for biologic therapy with mepolizumab.
Exclusion Criteria:
* Asthma exacerbation, within 6 weeks prior to screening that required hospitalization or emergency room visit.
* Prior use of other biologics (including but not limited to Omalizumab, Reslizumab, Dupilumab, Benralizumab etc., for asthma or any other indications) that has potential to interfere/ affect disease progression, in the previous 6 months.
* Pregnant or nursing women, or women of child-bearing potential.
* History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician.
* Patients with a history of conditions other than asthma that could result in elevated eosinophils (e.g. hypereosinophilic syndromes, Churg-Strauss Syndrome, eosinophilic esophagitis).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04612556
Study Brief:
Protocol Section:
NCT04612556