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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT03718793
Eligibility Criteria:
Inclusion Criteria:
* symptoms of asthma and objective evidence of variable or reversible airway obstruction according to at least one of the following criteria
* significant response to bronchodilator (in subjects 7 years or older: FEV1 (forced expiratory volume in 1st second) or FVC (forced vital capacity) increases at least 12 % and 200 ml; in 4-6 years old subjects R5 decreases at least 40 %)
* in at least 12 years old subjects significant diurnal variation (at least 20 % and 60 l/min on at least three days) or significant response to bronchodilator ( at least 15 % and 60 l/min on at least three occasions) in PEF (peak expiratory flow) during a two-week monitoring
* significant airway hyperreactivity (PD20 FEV1 of methacholine less than 600 µg in at least 16 years old subjects, FEV1 decreases at least 15 % in exercise test in 7-15 years old, or R5 increases at least 40 % during free-running test in 4-6 years old subjects)
Exclusion Criteria:
* current smoking
* regular anti-inflammatory asthma medication (will be paused for at least 4 weeks before enrollment)
* other chronic pulmonary disease
* other diseases that in the opinion of the treating physician prevents participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
65 Years
Study:
NCT03718793
Study Brief:
Protocol Section:
NCT03718793