Asthma L-Citrulline Pilot Study

Completed · Not applicable

Conditions studied: Asthma

In brief

This study will evaluate whether treatment with L-citrulline, which is an amino acid found in some foods, can increase levels of L-arginine and thereby restore the concentration of nitric oxide (NO) in the airways.

Key facts

Study ID

NCT02943161

Run by

University of Colorado, Denver

People needed

41

Starts

2017-04-05

Expected to finish

2019-03-31

Last updated by the study team

2020-02-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adequate completion of informed consent process with written documentation
• Male and female patients, 18 - 70 years old, inclusive
• Physician diagnosis of asthma (for medical records, ICD 10 coding for physician's diagnosis)
• All racial/ethnic backgrounds may participate
• BMI ≥ 30
• Treatment of controller asthma medication(s) ≥ 4 weeks
• Smoking history ≤10 pack years and no smoking in the last year
• V1 eNO ≤ 30ppb (may be repeated 3x during visit; lowest ppb will be kept)

You may not qualify if…

• Respiratory tract infection within the 4 weeks prior to the study (may re-enroll after 4 weeks).
• Oral or systemic corticosteroid burst (for any indication) within the 4 weeks
• One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout.
• Asthma-related ER visit within the previous 4 weeks of Visit 1
• Significant concomitant medical illness, including (but not limited to)
• Heart disease
• Cancer
• Uncontrolled diabetes,
• Chronic renal failure (creatinine > 2.0) at Visit 1 (Associated with higher ADMA levels)
• Untreated sleep apnea
• Other chronic lung/respiratory diseases (COPD, IPF, etc.)
• High dose inhaled steroids (> 1000 mcg/day of Fluticasone or equivalent)
• Current statin use (statins lower ADMA levels); patients may stop statins with approval from their primary physician and enroll after a 6-week washout
• Positive urine pregnancy test at Visit 1 or at any time during the study
• Intolerance or allergy to L-arginine or L-citrulline
• Concomitant use of PDE5 drugs or oral mononitrates
• Participation in an intervention study, use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
• 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
• Breastfeeding

Where it is running

• University of Colorado — Aurora, Colorado, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.