Phase 2
N=50
L-arginine in Severe Asthma Patients Grouped by Exhaled Nitric Oxide Levels
Asthma · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT01841281 ↗Enrolled (actual)
50
Serious AEs
3.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Acute Exacerbation at 3 Months — 2.7; 2.2; 1.6; 2.2 Events — p=0.78
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- L-Arginine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Nicholas Kenyon
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Acute Exacerbation at 3 Months |
2.7; 2.2; 1.6; 2.2; 2.1; 2.7 | 0.78 |
| SECONDARY Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) |
-0.02; 0.01; 0.03; -0.03; 0.01; 0.13 | 0.09 |
Summary
The major impact of this study will be to identify the adult severe asthma cohort that will benefit from supplemental L-arginine therapy. The investigators hypothesize that a subset of adult severe asthma patients will respond to supplemental L-arginine and derive clinical benefit from the addition of this therapy to standard-of-care asthma medications. The investigators hypothesize that the patients that benefit most will have low exhaled nitric oxide concentrations (< 20 ppb) at baseline.
Eligibility Criteria
Inclusion Criteria
- Adults >18 yrs of age
- Diagnosis of severe asthma based on American Thoracic Society Workshop definition (Am J Respir Crit Care Med 2000; 162:2341)
- Active asthma medications of high dose inhaled corticosteroids plus long-acting beta agonist
- History of recent asthma exacerbations or Asthma control test score 15 pack years
- Actively taking or known intolerance to L-arginine
Data sourced from ClinicalTrials.gov (NCT01841281). 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.