Supplementing L-citrulline to Overweight Late Asthma oNset Phenotypes (SANDIA)
Asthma, Obesity
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Adequate completion of informed consent process
- Male and female patients
- Physician diagnosis of asthma
- Able to perform reproducible spirometry according to ATS criteria
- Pre-bronchodilator FEV1 >/= 50% of predicted at Visit 0
- Confirmation of asthma
- All racial/ethnic backgrounds may participate.
- BMI >/= 30
- Regular treatment with ICS or ICS/LABA or LAMA combination medication for at least 1 month; participants can be on biologics.
- Smoking history </= 10 pack years and no smoking in the last 3 months
- Age of asthma onset (diagnosis) >/= 12 years
- FeNO </= 30 ppb
- ACQ >/= 0.50 or ACT </=19
Exclusion Criteria:
- Respiratory tract infection within the 4 weeks prior to Visit 1
- 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)
- Asthma-related ER visit within the previous 4 weeks of Visit 0
- History of ICU admission/intubation due to asthma in the past 1 year
- 3 or more asthma exacerbations requiring treatment with systemic corticosteroids for more than three days in the past year consistent with severe asthma
- Asthma exacerbation requiring systemic corticosteroids within the 4 weeks prior to Visit 0.
- Chronic renal failure
- Positive urine cotinine or THC test on the day of the bronchoscopy visit
- 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
- Untreated sleep apnea
- 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
Sites / Locations
- Duke University (Asthma, Allergy and Airway Center)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
L-citrulline
Matching Placebo
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.