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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT01907334
Eligibility Criteria:
Inclusion Criteria:
* parent/legal guardian and subject must be able to speak and understand English and patient must be willing and able to give assent to take part in the study
* diagnosed with asthma for at least 6 months
* able to demonstrate inhalation technique with study device
* if taking inhaled corticosteroids, dose must be stable for 2 weeks
* no significant concomitant medical conditions or abnormal physical findings on screening except for those consistent with asthma and allergic rhinitis
* airway responsiveness to methacholine with a baseline provocational dose causing an increase of at least 40% in R5 (PC40R5) at no more than 8 mg/mL
Exclusion Criteria:
* female who has started menstruating
* past or present history of any allergic reaction to any of the medications or formulations administered in this study
* prior treatment with systemic corticosteroids in last 30 days or more than 4 courses in previous 12 months
* use of short-acting beta-agonist more than two times per week in the previous month
* use of long-acting beta-agonist in the 3 weeks before the first methacholine challenge or during the study
* change in dosage of inhaled corticosteroids in previous 30 days, nasal steroids in previous 15 days and montelukast in last 7 days
* history of life-threatening asthma, including loss of consciousness, intubation and/or admission to ICU
* hospitalization for acute asthma within past year
* inability to withhold the following medications before methacholine challenges:
* short-acting beta-agonists at least 6 hours
* regular long-acting beta-agonists at least 3 weeks
* inhaled corticosteroid at least 2 hours
* montelukast at least 24 hours
* aspirin and non-steroid anti-inflammatory drugs at least 48 hours
* caffeine at least 4 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
11 Years
Study:
NCT01907334
Study Brief:
Protocol Section:
NCT01907334