Phase 2 Completed N=20 Randomized Quadruple-blind Treatment

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

Asthma

Source: ClinicalTrials.gov NCT00280683 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2013

Primary outcomePrimary: Number of Asthma Exacerbations in Three Months — 30; 31 exacerbations

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.

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	—

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

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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. Informational only — not medical advice.