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



Status:Enrolling by invitation
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:September 2015
End Date:January 2019

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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.

Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart
disease; however, a link is all they have found. In a previously funded grant, using a double
blind, randomized experimental design, the investigators explored the effect of an acute dose
of Kuvan or an antioxidant cocktail (1000mg of vitamin C, 600IU of vitamin E, and 600mg
alpha-lipoic acid) on vascular health in patients with COPD. Consequently, the investigators
found in separate experiments, that a single dose of both antioxidants and Kuvan transiently
improves vascular health in patients with COPD. The current project is an attempt to expand
on the investigator's previous findings and explore the effects of sub-chronic use of
antioxidants and Kuvan on sustaining the improvements in vascular health in COPD.

Inclusion Criteria:

- patients with medically diagnosed COPD

- apparently healthy controls

Exclusion Criteria:

- FEV1/FVC >0.7 (normal lung function in patients only)

- Clinical diagnosis of heart disease or diabetes

- Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)

- uncontrolled high blood pressure

- high blood pressure in your lungs

- thyroid problems

- Fluid in the lungs

- Sleep apnea

- Anemia

- Raynaud's Phenomenon

- GI bleeding

- Gangrene of the digits

- History of low platelets or coagulopathies

- Phenylketonuria (PKU)

- Any allergy to Kuvan
We found this trial at
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Augusta, Georgia 30912
Phone: 706-721-5998
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Augusta, GA
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