CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
Tetrahydrobiopterin (BH4) +1 moredrug
Likely dose
Not stated in 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/NCT02774226
NCT02774226Phase 2Completed

Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease

Augusta University·interventional·Posted May 17, 2016·Updated Feb 23, 2021

In Brief

A Phase 2 clinical trial evaluating Tetrahydrobiopterin (BH4) and Antioxidant Cocktail for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 15 participants across 1 site.

Detailed Summary

Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent evidence indicates that COPD is associated with multiple systemic consequences including vascular endothelial dysfunction. Recently, it has been suggested that more patients with COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO) bioavailability resulting in vascular endothelial dysfunction in patients with COPD are important as endothelial dysfunction has been indicated to be an independent predictor of future atherosclerotic cardiovascular disease and events.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 17, 2016
Enrollment StartSep 1, 2015
Primary CompletionJul 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.1 years ago

Interventions

Tetrahydrobiopterin (BH4)drug

12 week intervention

Antioxidant Cocktaildietary

12 week intervention