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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00995904
Eligibility Criteria:
Key Inclusion Criteria:
1. Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH \[EPR\] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening.
2. Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
3. Body weight \>=45 lbs, body mass index (BMI) \<=30 kg/m2
4. ICS users had to have been taking an ICS for \>=3 months and on a stable dose for \>= 1 month before Visit 1.ICS users had to be stable enough and able to withhold their therapeutic ICS for 24 hours prior to study drug administration,
5. Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.
Key Exclusion Criteria:
1. Females of child-bearing potential/menarche.
2. Diagnosis of any other significant chronic illness or abnormality.
3. Use of corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
11 Years
Study:
NCT00995904
Study Brief:
Protocol Section:
NCT00995904