Supplementing L-citrulline to Overweight Late Asthma oNset Phenotypes

Launched by UNIVERSITY OF COLORADO, DENVER · Mar 19, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called L-citrulline on people who have obesity-related asthma that starts later in life (after childhood). Researchers want to see if taking L-citrulline can improve asthma control and lung function in patients who are not responding well to standard asthma treatments. The study will involve 54 participants who will take either L-citrulline or a placebo (a harmless sugar pill) for eight weeks, followed by a break before switching treatments. They will measure asthma symptoms and lung health to evaluate the results.

To be eligible for the trial, participants must be adults aged 18 to 74 with a physician-confirmed asthma diagnosis, a body mass index (BMI) of 30 or higher, and a specific level of asthma control as measured by questionnaires. Participants should also have been on asthma treatments for at least a month. Those with certain health conditions or recent asthma-related emergencies may not qualify. Throughout the study, participants can expect regular check-ins and tests to monitor their asthma and overall health. The research team is experienced in conducting asthma studies, ensuring a high level of care and oversight during the trial.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adequate completion of informed consent process
• • 2. Male and female patients
• • 3. Physician diagnosis of asthma
• • 4. Able to perform reproducible spirometry according to ATS criteria
• • 5. Pre-bronchodilator FEV1 \>/= 50% of predicted at Visit 0
• • 6. Confirmation of asthma
• • 7. All racial/ethnic backgrounds may participate.
• • 8. BMI \>/= 30
• • 9. Regular treatment with ICS or ICS/LABA or LAMA combination medication for at least 1 month; participants can be on biologics.
• • 10. Smoking history \</= 10 pack years and no smoking in the last 3 months
• • 11. Age of asthma onset (diagnosis) \>/= 12 years
• • 12. FeNO \</= 30 ppb
• • 13. ACQ \>/= 0.50 or ACT \</=19
• Exclusion Criteria:
• • 1. Respiratory tract infection within the 4 weeks prior to Visit 1
• • 2. 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 4-week washout prior to Visit 0)
• • 3. Asthma-related ER visit within the previous 4 weeks of Visit 0
• • 4. History of ICU admission/intubation due to asthma in the past 1 year
• • 5. 3 or more asthma exacerbations requiring treatment with systemic corticosteroids for more than three days in the past year consistent with severe asthma
• • 6. Asthma exacerbation requiring systemic corticosteroids within the 4 weeks prior to Visit 0.
• • 7. Chronic renal failure
• • 8. Positive urine cotinine or THC test on the day of the bronchoscopy visit
• • 9. Positive urine (or serum) pregnancy test at Visit 0 or at any time during the study
• • 10. Intolerance or allergy to L-arginine or L-citrulline
• • 11. Concomitant use of PDE5 drugs or oral mononitrates
• • 12. Untreated sleep apnea
• • 13. Participant in an interventional drug study or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study