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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT02381158
Eligibility Criteria:
Inclusion Criteria:
* Informed and subscribed consent before any procedure
* Age range : 2 - ≤5 years
* Male and female patients
* Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months)
* PAI positive (at least one primary and two secondary ):
Primary:
1. one parent with asthma
2. Atopic Dermatitis
3. sensibilisation to air allergen
Secondary:
1. Food sensibilization
2. wheezing also not during the infective episodes
3. eosinophilia (\>4%)
Exclusion Criteria:
* story of severe wheeze requiring hospitalization
* treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks
* structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc)
* Persistent infections
* aspiration lung disease (gastroesophageal reflux disease, etc.)
* Cystic fibrosis
* prematurity or bronchopulmonary dysplasia
* Tuberculosis
* primary ciliary dyskinesia
* congenital heart disease
* pulmonary foreign body
* bronchiectasis
* Immunodeficit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
5 Years
Study:
NCT02381158
Study Brief:
Protocol Section:
NCT02381158