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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00158834
Eligibility Criteria:
Inclusion criteria:
* Children with a documented history of asthma.
* Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
* Must be able to perform reproducible lung function tests.
* Must have a positive RAST or skin prick test.
* During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine \< 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.
Exclusion criteria:
* History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
* Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
* Received oral corticosteroids within 4 weeks prior to visit 1.
* Existence of any disorder that affects growth.
* Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT00158834
Study Brief:
Protocol Section:
NCT00158834