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Study of L-Citrulline for Deployment-Related Asthma

This study is looking into whether L-citrulline, an amino acid, can help improve asthma symptoms in service members who developed asthma after military deployment. Many people returning from deployment experience asthma that doesn't respond well to standard treatments, possibly due to exposures like burn pits. Researchers want to see if L-citrulline, given as a powder mixed with water, can improve your asthma control and levels of FeNO (a gas in your airways related to inflammation). You might receive L-citrulline or a placebo (an inactive substance that looks the same). The study is for adults aged 18 to 70 who have deployment-related asthma. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 75 participants. Participants will receive either L-citrulline or a matching placebo.
What's involved
You would take L-citrulline or placebo orally for 7 weeks. Your asthma control and FeNO levels will be measured throughout the study, up to 22 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored through study completion, which is up to 22 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05259904

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
University of Colorado, Denver
~75 participants
Updated 2023-04-06 on ClinicalTrials.gov
What's tested:L-citrullinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Asthma Control Questionnaire
Measured over Through study completion, up to 22 weeks
+1 more outcome measured

Conditions

Post Deployment Related Asthma
Asthma

Explore related trials

AsthmaDeployment Related Asthma

Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • Fernando Holguin, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Colorado Denver- Anschutz Medical Campus

Who to contact

University of Colorado Asthma and Research Education Team
[email protected]
1-844-365-0852
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Change in Asthma Control QuestionnaireThrough study completion, up to 22 weeks

    To determine L-citrulline efficacy, reduction in questionnaire scores determined

  • Change in FeNO valuesThrough study completion, up to 22 weeks

    To determine L-citrulline efficacy, increase in FeNO values determined