Phase 2
N=20
Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00280683 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Number of Asthma Exacerbations in Three Months — 30; 31 exacerbations
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- L-arginine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Davis
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Asthma Exacerbations in Three Months |
30; 31 | — |
| SECONDARY L-arginine Serum Concentration |
0.002; 0.0011 | — |
Summary
Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a protective role in patients with moderate to severe asthma. The investigators believe that a natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma exacerbations and improve the asthma care of moderate to severe asthma patients.
This study is a randomized, placebo controlled trial in which subjects will receive either 3 months of L-arginine supplementation or a placebo. The investigators will monitor subjects' symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each monthly visit.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe persistent asthma
- Subject is stable on same asthma medications for at least one month
- If the subject is a woman of child-bearing age, a negative pregnancy test
Exclusion Criteria
- Less than 18 yrs/ age
- Baseline Forced Expiratory Volume in 1 second (FEV1) <40% predicted
- Known or suspected allergy to L-arginine
- Pregnant women, nursing women, or women actively trying to achieve pregnancy
- Current smokers
- Subjects with more than a 15 pack-year history of smoking
Data sourced from ClinicalTrials.gov (NCT00280683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.