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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT02024204
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years and \<75
* Meet criteria for World Trade Center Environmental Health Center enrollment
* Onset of lower respiratory symptoms after 9/11/01
* Persistent lower respiratory symptoms (\> 2 times per week)
* Pre-bronchodilator forced expiratory volume in one second (FEV1) within normal limits
* \< 5 pack-year tobacco history
* Not current smoker
* Asthma Control Test Score ≤ 19
* Normal chest x-ray
Exclusion Criteria:
* Age \< 18 years and ≥75
* Lower respiratory symptoms or asthma history pre 9/11/01
* No persistent lower respiratory symptoms
* pre-bronchodilator FEV1 within normal limits
* \> 5 pack year tobacco
* Current smoker
* Abnormal Chest X-Ray or parenchymal changes on high resolution computed tomography
* Uncontrolled major chronic illness (diabetes mellitus, congestive heart failure, cancer)
* History of significant non-World Trade Center occupational or environmental exposure
* Allergy to study drug
* Pregnancy, lactation or plans to become pregnant
* Chronic oral corticosteroid use
* High risk of fatal or near-fatal asthma within the previous 2 years
* Other lung disease (Idiopathic pulmonary fibrosis,sarcoid, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02024204
Study Brief:
Protocol Section:
NCT02024204