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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04442256
Eligibility Criteria:
Inclusion Criteria:
Dupilumab treatment group:
* Signed and dated informed consent has been obtained
* Age 18 - 70 years
* Male or female
* Diagnosed with AERD (nasal polyps, allergic asthma, aspirin intolerance)
* Chronic rhinosinusitis with nasal polyps (CRSwNP) (according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines)8
* Documented aspirin intolerance
* Asthma bronchial diagnosed by a respiratory physician (based on Global -Initiative for Asthma guidelines)9
Exclusion Criteria:
* Pregnancy
* Clinically significant abnormal laboratory values and active infection (Tbc, HIV, hepatitis A/B/C)
* History of malignancy or immunodeficiency
* Chronic obstructive lung disorders (COPD), other obstructive lung disorders (bronchiolitis)
* Need for systemic corticosteroid therapy 1 month prior to screening visit Eosinophilic pneumonia and Churg-Strauss Syndrome
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04442256
Study Brief:
Protocol Section:
NCT04442256