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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— COPD-LT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774226
• Other study ID #: COPD-LT
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: July 30, 2018

Study information

• Verified date: February 2021
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tetrahydrobiopterin (BH4)
12 week intervention

Dietary Supplement:
• Antioxidant Cocktail
12 week intervention

Locations

Country	Name	City	State
United States	Georgia Prevention Institute	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Flow Mediated Dilation	Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and 12 weeks after treatment.	Change from Baseline and 12 weeks
Secondary	Change in PWV (Pulse Wave Velocity)	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.	Change from Baseline and 12 weeks
Secondary	FEV1 %Predicted	Forced Expiratory Volume in 1 second. Pulmonary Function Test (PFT).	Change from Baseline and 12 weeks
Secondary	Percent of ACH to Heat Max	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).	Change from Baseline and 12 weeks