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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT05259904
Eligibility Criteria:
Inclusion Criteria:
* Adequate completion of informed consent process with written documentation
* Male and female patients, 18 - 70 years old, inclusive
* Meets criteria for deployment related asthma or DRA (New onset of persistent respiratory symptoms of cough, dyspnea, wheezing and/or chest tightness during or after post-9/11/2001 military deployment to Southwest Asia, accompanied by a post-bronchodilator increase in FEV1 ≥ 12% and an increase in FEV1 ≥ 200 milliliters on pulmonary function testing and/or methacholine challenge showing airways hyperresponsiveness with a 20 percent drop in FEV1 (PC\[-20\] FEV1) ≤ 16 mg/mL. ) Historical results from previous studies or documented in clinical records within the last 24 months are acceptable alternatives
* Able to perform reproducible spirometry according to ATS criteria
* All racial/ethnic backgrounds may participate
* Smoking tobacco history ≤15 pack years and no smoking in the last 3 months
* Suboptimal asthma control at baseline (ACQ ≥ 0.5 or ACT\<19)
Exclusion Criteria:
* Respiratory tract infection within the 4 weeks prior to Visit 0
* Pulmonary-related ER visit within the 4 weeks prior to Visit 0
* Oral or systemic corticosteroid burst (for any indication) within the 4 weeks prior to Visit 0. One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout prior to Visit 0
* Significant concomitant medical illness at the discretion of the PI, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases
* Chronic renal failure (creatinine \> 2.0) at Visit 0 (Associated with higher ADMA levels)
* Positive urine (or serum) pregnancy test at Visit 0 or at any time during the study
* Intolerance or allergy to L-arginine or L-citrulline
* Concomitant use of PDE5 drugs or oral mononitrates
* Unable or unlikely to complete study assessments in the opinion of the Investigator
* Study intervention poses undue risk to patient in the opinion of the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05259904
Study Brief:
Protocol Section:
NCT05259904