CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Sodium Nitrite +2 moredrug
Likely dose
Sodium Nitrite 20 mgfrom 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/NCT02433977
NCT02433977Phase 2Completed
CompareCT.gov

A Proof of Concept Study to Determine the Effects of NOX and Conjugated Linoleic Acid on Asthmatics

Gladwin, Mark, MD·interventional·Posted May 5, 2015·Updated Apr 27, 2021

In Brief

A Phase 2 clinical trial evaluating Conjugated Linolenic Acid, Sodium Nitrite, and 1 other intervention for Asthma. Completed, enrolled 6 participants across 1 site.

Detailed Summary

This study will examine the hypothesis that in obese asthmatics; treatment with NOx + CLA is well tolerated, safe and will increase eNO while reducing airway oxidative stress. Allied with this, the investigators will define whether supplementing with this bioactive mediator modifies the airway microbiome, and reduces airway inflammation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 5, 2015
Enrollment StartSep 1, 2015
Primary CompletionNov 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.2 years ago

Interventions

Conjugated Linolenic Aciddietary

CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day

Sodium Nitritedrug

Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)

Sodium Nitratedrug

Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)