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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00361920
Eligibility Criteria:
Inclusion Criteria:
1. Will meet American Thoracic Society criteria for asthma
2. Pulmonary function tests consistent with asthma. This includes a baseline FEV1 \< 80% predicted as well as a 12% improvement in FEV1 following up to 4 puffs of albuterol.
3. Subjects must be 12 to 65 years old.
Exclusion Criteria:
1. Viral infection within four weeks of the starting date.
2. Abnormal hepatic function.
3. History of COPD
4. Pregnancy.
5. History of smoking.
6. Anemia (hemoglobin less than 12 gm %)
7. Concurrent therapy with anticonvulsants, erythromycin, rifampin and any systemic asthma medication including Singular®, Xolair® or oral prednisone.
8. Greater than 500 mcg per day of inhaled corticosteroids
9. Suspected non-compliance with medical care.
10. Abnormal prednisone pharmacokinetics (applies to phase 2 of trial)
11. Patients with severe medical conditions that in the view of the investigator prohibits participation in the study (specify as required)
12. Use of any investigational agent in the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT00361920
Study Brief:
Protocol Section:
NCT00361920