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L-citrulline for Asthma (SANDIA Trial)

Phase 2

Recruiting

Led By Fernando Holguin, MD, MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physician diagnosis of asthma

Age of asthma onset (diagnosis) >/= 12 years

Must not have

History of ICU admission/intubation due to asthma in the past 1 year

Asthma-related ER visit within the previous 4 weeks of Visit 0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 32 weeks

Summary

This trial is testing whether L-citrulline, an L-arginine donor, can improve the asthma control and lung function in obese late onset asthmatics by increasing the L-arginine/ADMA ratio, FeNO levels, and reducing bronchoconstriction and lung inflammation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the supplement intake site, gastrointestinal issues like upset stomach or diarrhea, and changes in blood pressure. Allergic reactions could occur but are less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with asthma by a doctor.

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I was diagnosed with asthma when I was 12 years old or older.

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I have been diagnosed with asthma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was admitted to the ICU or needed a breathing tube for asthma in the last year.

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I visited the ER for asthma within the last 4 weeks.

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I haven't taken any corticosteroids in the last 4 weeks.

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I have long-term kidney disease.

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I've needed steroids for my asthma in the last 4 weeks.

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I am currently taking PDE5 inhibitors or oral mononitrates.

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I have had 3 or more severe asthma attacks in the last year.

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I have sleep apnea that has not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 32 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 32 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 32 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Asthma Control Questionnaire

Change in Asthma Control Test

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: L-citrullineExperimental Treatment1 Intervention

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.

Group II: Matching PlaceboPlacebo Group1 Intervention

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.

0 / 11Eligibility criteria met