Effects of L-arginine Supplementation in Adults With Moderate to Severe Asthma

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Collaborators: National Center for Research Resources (NCRR); National Institutes of Health (NIH)

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