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 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 12:52 AM
NCT ID:
NCT00393367
Eligibility Criteria:
Inclusion Criteria:
* Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"
* Males or females age 2 to 18 years
* Weight greater than or equal to 10 kilograms
* Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease
* Identified in triage as either "acute" or "critical"
* Asthma score of 8 or greater
* Systemic corticosteroid prescribed in the Emergency Department
* English-speaking parent/guardian present
* Parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria:
* Systemic corticosteroid use in the last 30 days
* Chronic lung diseases including cystic fibrosis
* Sickle cell anemia
* Immunodeficiency
* Cardiac disease requiring surgery or medications
* Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
* Known renal or hepatic dysfunction
* Exposure to varicella in the last 21 days
* Impending respiratory failure requiring positive pressure ventilation
* Altered level of consciousness
* Suspected foreign body aspiration or croup
* Prior enrollment in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT00393367
Study Brief:
Protocol Section:
NCT00393367