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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT02809235
Eligibility Criteria:
Inclusion Criteria:
1. Male and female participants, age 18 years and older at enrollment
2. Never smokers or \<10 pack year smoking history
3. Body mass index (BMI) \<25
4. Clinical history consistent with asthma for \>1 year
5. No use of an inhaled corticosteroid in the prior 3mo
6. Ability to perform reproducible spirometry according to ATS criteria
7. Baseline Forced expiratory volume in 1 second (FEV1) ≥ 60% predicted
8. Presence of bronchodilator reversibility, as defined by a minimum of 12% and ≥ 200 ml improvement after 4 puffs of albuterol, each 90 μg
9. Ability to provide informed consent, as evidenced by signing a copy of the consent form approved by the Institutional Review Board.
Exclusion Criteria:
1. Supplementation with fatty acids within the last 3 months
2. BMI ≥25
3. Pregnant or nursing
4. History of smoking (cigarettes, cigars, pipes, marijuana or any other substances) within the past 1 year, or \>10 pack-years total
5. Use of inhaled corticosteroid in the prior 3 mo
6. Lack of bronchodilator response to 4 puffs of albuterol
7. Medical contraindication to bronchoscopy/biopsy, i.e inability to stop aspirin, anticoagulant, or antiplatelet at any point during the study; coagulopathy; inability to lay flat; asthma exacerbation requiring corticosteroids in the preceding 4 weeks; history of adverse reaction or allergy to sedatives; history of difficult airway, or past difficulty with intubation
8. Major medical problems prohibiting study participation, i.e presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma
9. Evidence that the participant may be non-adherent to medication regimen, or may move from the performance site area before trial completion
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02809235
Study Brief:
Protocol Section:
NCT02809235