L-citrulline for Asthma
(SANDIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether L-citrulline, a supplement, can improve asthma control and lung function in individuals with a specific type of asthma that begins after childhood and is associated with obesity. The research team aims to determine if L-citrulline can enhance certain molecules that aid breathing and reduce inflammation. Participants will receive either L-citrulline or a placebo (a harmless substance resembling the treatment) in different phases to compare results. This trial suits individuals who have had asthma since at least age 12, have a BMI of 30 or above, and continue to struggle with asthma control despite regular inhaler use. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you need to stop taking your current medications. However, you must have been on regular treatment with certain asthma medications for at least one month, and you cannot use certain drugs like PDE5 inhibitors or oral mononitrates during the study.
Is there any evidence suggesting that L-citrulline is likely to be safe for humans?
Research has shown that L-citrulline is safe and generally well-tolerated. In past studies, even at much higher doses, it did not cause significant side effects. This treatment may improve asthma symptoms and lung function, particularly in individuals with asthma who are also obese. L-citrulline boosts nitric oxide levels, which can open airways and ease breathing. Participants have not reported any major negative effects, suggesting it could be a safe option for those considering joining a clinical trial.12345
Why do researchers think this study treatment might be promising for asthma?
Unlike the standard asthma treatments, which typically include inhaled corticosteroids and bronchodilators, L-citrulline offers a unique approach by potentially enhancing nitric oxide production in the body. Nitric oxide can help widen blood vessels and improve blood flow, which might reduce inflammation and improve respiratory function in asthma patients. Researchers are excited about L-citrulline because it is a naturally occurring amino acid, which could mean fewer side effects and a more holistic treatment option compared to conventional medications.
What evidence suggests that L-citrulline might be an effective treatment for asthma?
Research shows that L-citrulline can help improve asthma symptoms, particularly in individuals with obesity-related asthma. Past studies found that L-citrulline increases FeNO levels, indicating airway inflammation, and enhances overall asthma control. Participants in this trial will receive L-citrulline, which has improved lung function, demonstrated by larger increases in FEV1, a measure of air exhaled in one second. These benefits were more noticeable in individuals with low or normal FeNO levels. The treatment boosts nitric oxide production, reducing airway tightening and inflammation.12467
Who Is on the Research Team?
Fernando Holguin, MD, MPH
Principal Investigator
University of Colorado Denver- Anschutz Medical Campus
Are You a Good Fit for This Trial?
This trial is for adults with asthma that started after childhood, who are obese (BMI >= 30), and have a history of poor response to inhaled steroids. They should be on regular asthma medication but not have had an exacerbation or used systemic corticosteroids in the last month. Smokers or those with recent lung infections aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive 15g/day of L-citrulline or placebo for 8 weeks
Washout
Participants undergo a washout period between treatment phases
Treatment Period 2
Participants crossover to receive the alternate treatment (L-citrulline or placebo) for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- L-citrulline
Trial Overview
The study tests if L-citrulline improves asthma control and lung function in obese adults with late-onset asthma. Participants will take either L-citrulline or a placebo over two 8-week periods, separated by a washout period, to compare effects on their condition.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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 1 and 1a (if needed). Washout period of at least 5 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.
Administered in powder form that is mixed with water and taken orally, continuously, and daily for at least 7 weeks. Dispensed at Visits 1 and 1a (if needed). Washout period of at least 5 weeks and then enter crossover phase of an additional 7 weeks. Drug will be dispensed at Visit 4.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Duke University
Collaborator
Citations
L-Citrulline increases nitric oxide and improves control in ...
Short-term L-citrulline treatment improved asthma control and FeNO levels in obese asthmatics with low or normal FeNO. Larger FEV1 increments were observed in ...
l-Arginine supplementation in severe asthma
A recent clinical trial of l-citrulline supplementation in individuals with asthma found that l-citrulline increased FeNO and modestly improved forced ...
NCT02943161 | Asthma L-Citrulline Pilot Study
In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open- ...
Role of the l-citrulline/l-arginine cycle in iNANC nerve ...
Remarkably, the impaired iNANC relaxation after the early asthmatic reaction was restored by l-citrulline.
Find a Research Study
1. Determine if L-citrulline supplementation improves asthma control and increases FeNO (co-primary outcomes). Secondary outcomes will include changes in plasma ...
Phenotypic characteristics of asthma and morbidity are ...
L-citrulline supplementation can improve asthma control and lung function while augmenting exhaled nitric oxide (NO). From these and other ...
7.
respiratory-research.biomedcentral.com
respiratory-research.biomedcentral.com/articles/10.1186/1465-9921-13-68L-citrulline supplementation reverses the impaired airway ...
L-citrulline has been shown to restore impaired relaxation of airways after early asthmatic reaction [27].
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