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Completed

NCT Number: NCT02774226

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetrahydrobiopterin (BH4)

Drug

12 week intervention

Other names: Kuvan (Sapropterin Dihydrochloride)

Antioxidant cocktail

Dietary Supplement

12 week intervention

Other names: Vitamin C, Vitamin E, Alpha Lipoic Acid

Primary outcomes

  1. Change in Flow Mediated Dilation

    Time frame: Change from Baseline and 12 weeks

    Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and 12 weeks after treatment.

Secondary outcomes

  1. Change in PWV (Pulse Wave Velocity)

    Time frame: Change from Baseline and 12 weeks

    Change in pulse wave velocity (carotid to femoral) as measured using tonometry with the Sphygmocor Xcel system at baseline and after 12 weeks of treatment.

  2. FEV1 %Predicted

    Time frame: Change from Baseline and 12 weeks

    Forced Expiratory Volume in 1 second. Pulmonary Function Test (PFT).

  3. Percent of ACH to Heat Max

    Time frame: Change from Baseline and 12 weeks

    The laser imaging camera is a special camera that shines a low energy laser light on the surface of the skin to measure blood flow. The FLPI makes graphs, photos, and movies of skin blood flow. Acetylcholine is a vasoactive substance that will be used to increase skin blood flow. This variable is the percent of dilation caused by acetylcholine out of the max dilation cause by the warm water bath (44 C).

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Registry information

Acronym: COPD-LT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 17, 2016
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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