Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT05259904

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

Led by University of Colorado, Denver · Updated on 2023-04-06

75

Participants Needed

1

Research Sites

290 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Jewish Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Completed informed consent process with written documentation
  • Male or female aged 18 to 70 years inclusive
  • Diagnosed with deployment related asthma defined by new persistent respiratory symptoms during or after post-9/11/2001 deployment to Southwest Asia, with documented lung function changes or airway hyperresponsiveness within the last 24 months
  • Able to perform reproducible spirometry according to ATS criteria
  • Any racial or ethnic background may participate
  • Smoking history of 15 pack years or less and no smoking in the last 3 months
  • Suboptimal asthma control at baseline (ACQ score ≥ 0.5 or ACT score < 19)
Not Eligible

You will not qualify if you...

  • Respiratory tract infection within 4 weeks prior to first study visit
  • Pulmonary-related emergency room visit within 4 weeks prior to first study visit
  • Oral or systemic corticosteroid burst within 4 weeks prior to first study visit; one-time joint injections require 2-week washout
  • Significant other medical illness judged by investigator, including heart disease, cancer, uncontrolled diabetes, or other chronic lung diseases
  • Chronic renal failure with creatinine > 2.0 at first visit
  • Positive pregnancy test at first visit or during study
  • Allergy or intolerance to L-arginine or L-citrulline
  • Use of PDE5 inhibitors or oral mononitrates
  • Unable or unlikely to complete study assessments per investigator
  • Study intervention poses undue risk as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

National Jewish Health

Denver, Colorado, United States, 80206

Actively Recruiting

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Research Team

U

University of Colorado Asthma and Research Education Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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