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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT01426061
Eligibility Criteria:
Inclusion Criteria:
* Forced expiratory volume in 1 second (FEV1) ≥60% predicted
* A history of bronchial asthma for minimum 6 months prior to baseline
* An objective measure of abnormal variation in bronchial calibre(The objective measure were defined as at least one of the following)
1. a positive bronchodilator reversibility test, defined as increase in FEV1≥10% after 400 µg inhaled salbutamol;
2. a positive methacholine test, defined as a PD20 of \<1000 μg;
3. a positive test for exercise induced asthma defined as a fall in FEV1\>15% after a standardised 6 min exercise test; and
4. a positive peak expiratory flow (PEF) variability , defined by ≥3 days or 2 consecutive days with a differences between morning and evening PEF of \>20% during a 2-week period.
Exclusion Criteria:
* Hospitalization for asthma within 3 months,
* Asthma exacerbation during the last month,
* Changes in asthma medication within 30 days of screening
* A smoking history \> 10 pack-years and smoking within the last year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01426061
Study Brief:
Protocol Section:
NCT01426061