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 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT03011632
Eligibility Criteria:
Inclusion Criteria:
* a group of children (n=90) suffering from CRS (fulfilling the EPOS criteria, European Position Paper on Rhinosinusitis and Nasal Polyps) and asthma (fulfilling the API criteria, Asthma Predictive Index), including a 30-person subgroup diagnosed with clinically significant IgE-dependent hypersensitivity (accordance between symptoms and current exposure to sensitizing allergen),
* a group of children (n=30) suffering from CRS (fulfilling the EPOS criteria) but without asthma symptoms (negative API criteria), including a 15-person subgroup diagnosed with clinically significant IgE-dependent hypersensitivity (accordance between symptoms and current exposure to sensitizing allergen),
* a group of children (n=30) without symptoms of CRS (negative EPOS criteria) and without asthma symptoms (negative API criteria).
Exclusion Criteria:
* food allergy with symptoms affecting the respiratory tract
* contraindication to nasal endoscopy or contraindication to nasal mucosa biopsy
* hypertrophy of the third tonsil exceeding 60% of the nasopharynx (the criterion of obstruction being an indication for adenoidectomy). In these patients, the anatomical nasal obstruction may be the single cause of chronic inflammation in the airways, and hence verification of the hypotheses is impossible
* confirmed immunodeficiency
* exacerbation of asthma requiring systemic administration of glucocorticosteroids
* obesity, exposure to tobacco smoke
* other chronic illnesses and clinical conditions, which in the opinion of the researcher may influence the evaluation and the course of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT03011632
Study Brief:
Protocol Section:
NCT03011632