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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01028560
Eligibility Criteria:
Inclusion Criteria:
* Children between 18 months through 3 years who had at least 2 episodes of wheezing prior to enrolment.
* Positive skin tests or specific Immunoglobulin E (IgE) antibody titers to at least one of common airborne allergens: Dust Mite, cat, cockroach, mouse, dog, pollen (all allergy testing can be done at the screening visit at the study site).
* The child must also fulfill the criteria for high risk of developing persistent asthma by meeting at least one of the following major conditions OR 2 of the following minor conditions:
* Major criteria: History of atopic dermatitis and/or parental history of asthma.
* Minor criteria: MD-diagnosed allergic rhinitis, wheezing unrelated to colds, blood eosinophils above 4%.
Exclusion Criteria:
* The child has a severe systemic condition (other than allergy or asthma) including (but not limited to) seizures, major congenital anomalies, physical and intellectual delay, cerebral palsy, chest surgery, tuberculosis, primary or secondary immunodeficiency or cardiac disorder (except a hemodynamically insignificant atrial or ventricular septum defect or heart murmur).
* The child was born following 35 or less weeks of gestation.
* Parental report that the child received oxygen for more than 5 days in the neonatal period, or required mechanical ventilation at any time since birth.
* The child fails to thrive, defined as crossing of two major growth percentile lines during the last year.
* The child has chronic lung disease of prematurity (CLDP), cystic fibrosis or any other chronic lung disease.
* The child ever received immunotherapy.
* The child ever received i.v. gammaglobulins or immunosuppressants (other than corticosteroids for asthma).
* History of a life-threatening asthma exacerbation which required intubation and mechanical ventilation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
3 Years
Study:
NCT01028560
Study Brief:
Protocol Section:
NCT01028560