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 : Enrolling by invitation
First Posted : May 17, 2016
Last Update Posted : June 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease (COPD)||Drug: Tetrahydrobiopterin (BH4) Dietary Supplement: Antioxidant Cocktail||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Tetrahydrobiopterin (BH4)
Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline, 4 weeks, 8 weeks, and 12 weeks following, 5mg/kg, 10mg/kg, or 20mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.
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, 4 weeks, 8 weeks, 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.
Dietary Supplement: Antioxidant Cocktail
12 week intervention
- Change in Flow Mediated Dilation [ Time Frame: Change from Baseline, 4 weeks, 8 weeks, and 12 weeks ]
- Change in Biomarkers of Oxidative Stress [ Time Frame: Change from Baseline, 4 weeks, 8 weeks, and 12 weeks ]
- Femoral and Carotid tonometry measurements used to assess Arterial Stiffness [ Time Frame: Change from Baseline, 4 weeks, 8 weeks, and 12 weeks ]SphygmoCor Pulse Wave Analysis System (SphygmoCor, PWV Medical, Sydney, Australia), which uses applanation tonometry, will be used for accurate, non-invasive assessment of arterial stiffness. Aortic augmentation index will also be determined and is an index of arterial stiffness.
- Iontophoresis and Local Heating used to Measure Microvascular Function [ Time Frame: Change from Baseline, 4 weeks, 8 weeks, 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, sodium nitropruside and L-NAME are vasoactive substances that will be used to increase and decrease skin blood flow. The amount of drug delivered is based on the amount of current being delivered. Using this technique with such a low level current, there should be no drug that enters the body.
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|