CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Tetrahydrobiopterin (BH4) +1 moredrug
Likely dose
Tetrahydrobiopterin (BH4) 5 mg/kgfrom 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/NCT01398943
NCT01398943N/ACompleted

Regulation of Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease: A Mechanistic Approach

Augusta University·interventional·Posted Jul 21, 2011·Updated Dec 11, 2017

In Brief

A clinical study evaluating Tetrahydrobiopterin (BH4) and Antioxidant Cocktail for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 60 participants across 1 site.

Detailed Summary

More patients with chronic obstructive pulmonary disease (COPD) die from cardiovascular disease than direct pulmonary complications. Inflammation and oxidative stress, characteristic in COPD, are likely contributors to the reduction in nitric oxide (NO) bioavailability and vascular endothelial dysfunction in COPD patients; however, this has yet to be determined. Thus, the overall objective of this proposal is to identify the role of NO bioavailability in contributing to vascular endothelial dysfunction in patients with COPD and to provide insight into the molecular mechanisms involved. Our central hypothesis is that inflammation and oxidative stress, both independently, contribute to the reduction in NO bioavailability and vascular endothelial dysfunction in patients with COPD.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 21, 2011
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 14.9 years ago

Interventions

Tetrahydrobiopterin (BH4)drug

single dose = 5 mg/kg

Antioxidant Cocktaildietary

1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid