Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease (COPD-LT)
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ClinicalTrials.gov Identifier: NCT02774226 |
Recruitment Status :
Completed
First Posted : May 17, 2016
Results First Posted : February 23, 2021
Last Update Posted : February 23, 2021
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Condition or disease | Intervention/treatment | Phase |
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Chronic Obstructive Pulmonary Disease (COPD) | Drug: Tetrahydrobiopterin (BH4) Dietary Supplement: Antioxidant Cocktail | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | July 30, 2018 |
Actual Study Completion Date : | July 30, 2018 |

Arm | Intervention/treatment |
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Experimental: Tetrahydrobiopterin (BH4)
Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline and 12 weeks following 5mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.
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Drug: Tetrahydrobiopterin (BH4)
12 week intervention
Other Name: Kuvan (Sapropterin Dihydrochloride) |
Experimental: Antioxidant Cocktail
Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline and 12 weeks following an anti-oxidant cocktail (vitamin C 1000 mg, vitamin E 400 IU, and alpha lipoic acid 600 mg) taken once a day.
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Dietary Supplement: Antioxidant Cocktail
12 week intervention
Other Names:
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- 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.
- 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.
- FEV1 %Predicted [ Time Frame: Change from Baseline and 12 weeks ]Forced Expiratory Volume in 1 second. Pulmonary Function Test (PFT).
- 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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774226
United States, Georgia | |
Georgia Prevention Institute | |
Augusta, Georgia, United States, 30912 |
Principal Investigator: | Ryan Harris, Ph.D | Augusta University |
Documents provided by Ryan Harris, Augusta University:
Responsible Party: | Ryan Harris, Principal Investigator, Augusta University |
ClinicalTrials.gov Identifier: | NCT02774226 |
Other Study ID Numbers: |
COPD-LT |
First Posted: | May 17, 2016 Key Record Dates |
Results First Posted: | February 23, 2021 |
Last Update Posted: | February 23, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Flow-Mediated Dilation Kuvan Antioxidant FEV1 |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Vitamins Vitamin E Thioctic Acid |
Antioxidants Micronutrients Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Protective Agents Vitamin B Complex |