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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT00569192
Eligibility Criteria:
Inclusion Criteria:
* Male or female asthmatic children with mild to moderate persistent asthma.
* 12 months to 8 years of age.
* For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
* For infants age 12 to \<48 months old: 2 or more wheezing episodes in past 12 months which lasted \> 1 day and affected sleep.
* AND with at least one major or two minor risk factors.
Exclusion Criteria:
* Any other significant childhood illness/abnormality or chronic lung disease
* Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
* Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
* Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
* Any use of oral corticosteroids within 30 days of screening or prolonged use (\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
8 Years
Study:
NCT00569192
Study Brief:
Protocol Section:
NCT00569192