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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04990167
Eligibility Criteria:
Inclusion Criteria:
1. Children ages 6 to 11 years with controlled mild nonatopic persistent physician diagnosed asthma
1. Non-atopic asthma: absence of a positive SPT to inhaled aeroallergens or negative specific IgE to a common regional allergen panel; historical serum IgE less than 200 IU/ml; historical serum eosinophils less than 350 cells per microliter (cells/mcL); no history of eczema; no history of allergic rhinitis; no history of food allergy
2. Physician-diagnosed asthma: positive family history, recurrent asthma symptoms, bronchodilator responsiveness, and evidence of obstruction.
3. Mild persistent asthma: current treatment with as-needed albuterol or low-dose ICS or daily montelukast (Step 2 therapy)
4. Controlled asthma: Childhood Asthma Control Test score \>19
2. Pre-bronchodilator FEV1 ≥ 80% of predicted
Exclusion Criteria:
1. Oral corticosteroid use in the past 6 weeks
2. Use of ICS in combination with long-acting beta agonist or montelukast
3. History of life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years
4. Respiratory tract infection within the past 4 weeks
5. Any other chronic diseases or medical conditions (other than asthma) that in the opinion of the investigator would prevent participation in a trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT04990167
Study Brief:
Protocol Section:
NCT04990167