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NCT05259904 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Asthma and Post Deployment Related Asthma, sponsored by University of Colorado, Denver.

Recruiting
Registry status
Phase 2
Development phase
75
Enrollment target
1
Study location

NCT05259904 is a Phase 2 study of Asthma and Post Deployment Related Asthma that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 75 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05259904, a Phase 2 study of Asthma and Post Deployment Related Asthma, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
Phase 2
Development phase
75 participants
Enrollment target
1
Study location

Study 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 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 me

Interventions

  • DRUG Placebo
  • DRUG L-citrulline

Study Locations (1)

Colorado

  • National Jewish Health - Denver

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2023-03-08
Est. Completion 2028-10
Phase Phase 2

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT05259904

The ClinicalTrials.gov registry entry for NCT05259904 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05259904 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT05259904 about?

NCT05259904 is a clinical study titled "Study to Improve Deployment Related Asthma by Using L-Citrulline Supplementation". 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, patien...

What is the current status of trial NCT05259904?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2023-03-08. Estimated completion is 2028-10.

What conditions does trial NCT05259904 study?

This clinical trial studies the following conditions: Asthma, Post Deployment Related Asthma.

What interventions are being tested in trial NCT05259904?

The interventions under investigation include: Placebo (DRUG), L-citrulline (DRUG).

Who is sponsoring clinical trial NCT05259904?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05259904 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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