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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT01449435
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* Age \>3 and \<7 years
* Diagnosis of intermittent asthma
* In the last 24 months, at least 6 weeks of treatment with a controller medication (inhaled steroid and / or leukotriene receptor antagonist Singulair ®), or in the last 12 months, at least three episodes with an use of controller medications (inhaled steroid and / or the leukotriene receptor antagonist Singulair ®)
* The ability to perform three reproducible spirometries
* Examination in infection-free interval (\> 4 weeks infection-free)
* Minimum distance to the following asthma medications:
* Short-acting beta 2-agonists: 8 hours
* Ipratropium bromide: 24 hours
* Long-acting beta 2-agonists: 24 hours
* steroids: 4 weeks
* leukotriene antagonist: 4 weeks
Exclusion Criteria:
* Age older than 6 years or younger than 4
* The inability to perform spirometry
* Other chronic diseases or infections (eg. HIV, tuberculosis, malignancy)
* Participation in another study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
6 Years
Study:
NCT01449435
Study Brief:
Protocol Section:
NCT01449435