Adding L-citrulline to treatment for adults with obesity-related late-onset asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives eligible adults with obesity-related late-onset asthma either oral L-citrulline or a matching placebo and follows them for biochemical and clinical outcomes. The study targets participants who remain symptomatic on inhaled therapy and who have low FeNO, aiming to raise the L-arginine/ADMA ratio and NO availability. Outcomes include changes in the L-arginine/ADMA ratio, FeNO, spirometry, bronchial hyperreactivity, and asthma control scores. The design uses a placebo comparator to determine whether L-citrulline improves lung function and symptom control compared with placebo.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke University (Asthma, Allergy and Airway Center)
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Fernando Holguin, MD, MPH — University of Colorado Denver- Anschutz Medical Campus
• Study coordinator: Asthma Research
• Email: asthmaresearch@ucdenver.edu
• Phone: 1 (844) 365-0852

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using an intragastric balloon to improve asthma control in obese patients

  This study is testing if using an intragastric balloon can help obese patients with uncontrolled asthma manage their symptoms better when combined with diet and exercise changes.

  Recruiting University Hospital, Toulouse · Toulouse, Occitanie · NCT05364957

• Research on health inequality and genetic disparity in cardiovascular diseases

  This study is trying to understand how health differences and genetics affect heart diseases in people from various ethnic backgrounds in the UK to help improve treatments for everyone.

  Recruiting Future Genetics Limited · Wolverhampton, West Midlands · NCT03987633

• Evaluating a new treatment for asthma in obese adults

  This study is testing a new treatment for asthma in obese adults to see if it can help reduce inflammation and improve their breathing.

  Recruiting Phase 2 University of Colorado, Denver · Aurora, Colorado · NCT03762395

• Investigating the effects of obesity and metabolic syndrome on asthma and airway health

  This study is testing how obesity and metabolic syndrome affect asthma and lung health in different groups of people with and without asthma.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT03215836

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.