Status:
RECRUITING
Study to Improve Deployment Related Asthma by Using L-Citrulline Supplementation
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Jewish Health
United States Department of Defense
Conditions:
Post Deployment Related Asthma
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Service men and women returning from deployment are significantly more likely to develop asthma and severe respiratory symptoms from airway obstruction. Why this happens is not well known, but exposur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05259904
Start Date
March 8 2023
End Date
October 1 2028
Last Update
April 6 2023
Active Locations (1)
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1
National Jewish Health
Denver, Colorado, United States, 80206