Post Deployment Related Asthma study: L-citrulline
Official title Study to Improve Deployment Related Asthma by Using L-Citrulline Supplementation
ClinicalTrials.gov ID: NCT05259904
What this study is testing
What is L-citrulline?
This is an investigational amino acid powder being studied as a potential treatment for post-deployment related asthma. It is designed to be converted by the body into L-arginine, which may help increase nitric oxide levels in the airways.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if L‑citrulline can improve lung function and asthma control in these patients.
- Who it's for
- Obese adults who have asthma that started after military deployment.
- What's involved
- Participants will take the L‑citrulline supplement and attend clinic visits for routine tests and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Able to perform reproducible spirometry according to ATS criteria
- All racial/ethnic backgrounds may participate
You likely can't join if
- 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.
- Significant concomitant medical illness at the discretion of the PI, including (but not limited to) heart disease, cancer, uncontrolled diabetes...
- 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
See the full eligibility criteria
- 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...
- 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)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Denver, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Denver, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.