Study to Improve Deployment Related Asthma by Using L-Citrulline Supplementation

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05259904
Phase
PHASE2
Status
Recruiting
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Conditions

  • Asthma
  • Post Deployment Related Asthma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • L-citrulline — DRUG
    7 weeks of treatment with 15 g/day of orally administered (powder form mixed with water) L-citrulline
  • Placebo — DRUG
    7 weeks of treatment with orally administered matching placebo (to 15 g/day of L-citrulline)

Study Details

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 exposure to diesel, burn pits, biomass smoke, and sandstorms are thought to play a role. Ultimately, patients with deployment related asthma develop a complex airway disease that does not respond well to standard asthma medications. Therefore, it is imperative that safe and affordable treatments that could improve quality of life and symptoms are studied. It has been previously shown that adult patients with poorly controlled asthma have an abnormal regulation of an amino acid called L-arginine and airway nitric oxide (FeNO), a gaseous molecule normally produced in the airways of healthy people. In healthy people, nitric oxide is present in amounts that help keep the airways open. However, in some patients with asthma, nitric oxide and L-arginine are often low. The investigators' preliminary data in obese asthmatics show that L-citrulline, which is an amino acid that can be metabolized into L-arginine, improved lung function and asthma control, while increasing the levels of FeNO. This is potentially shifting the paradigm in how investigators think of asthma management, as rising FeNO is often thought of being a bad sign. Based on this, the study investigators hypothesize that an L-citrulline-based drug strategy will normalize nitric oxide metabolism, suppress oxidative inflammatory responses and improve airway function in obese patients with asthma. The study proposal presents a clinical trial approach to treat deployment related asthma patients using L-citrulline as an add-on therapy to improve asthma control. If this confirms the investigators' previous study results, the investigators will be in route for developing the only precision-based therapy available to treat this asthma phenotype. These study results will potentially show that L-citrulline is a safe, tolerable medication that can make a significant impact on the respiratory health of a large segment of our active and veteran population at a reasonable cost.

Key Dates

Start date
Mar 8, 2023
Status verified
Apr 2023
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: L-citrulline
    L-citrulline with a dose of 15 g/day will be administered in powder form that is mixed with water and taken orally, continuously and daily for at least 7 weeks. Dispensed at Visits 0a/1. Washout period of 4 to 6 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.
  • Placebo Comparator: Matching Placebo
    Administered in powder form that is mixed with water and taken orally, continuously, and daily for at least 7 weeks. Dispensed at Visits 0a/. Washout period of 4 to 6 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.

Primary Outcome Measure

Change in Asthma Control Questionnaire [ Time Frame: Through study completion, up to 22 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206
NJH SEALS Team
[email protected]
303-398-1748
Cecile Rose, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

By condition
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By specialty
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By research site
National Jewish Health· Denver, CO

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