CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
L-Arginine +1 moredrug
Likely dose
L-Arginine 1 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01841281
NCT01841281Phase 2Completed

Phase II Study of L-arginine in Severe Asthma Patients Grouped by Exhaled Nitric Oxide Level

Nicholas Kenyon·interventional·Posted Apr 26, 2013·Updated Apr 21, 2020

In Brief

A Phase 2 clinical trial evaluating L-Arginine and Placebo for Asthma and Inflammation. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Inflammation
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2013
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2018
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 13.2 years ago

Interventions

L-Argininedrug

L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.

Placebodrug

Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients.