- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774226
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease (COPD-LT)
February 5, 2021 updated by: Ryan Harris, Augusta University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Augusta, Georgia, United States, 30912
- Georgia Prevention Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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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12 week intervention
Other Names:
|
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.
|
12 week intervention
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from Baseline and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline and 12 weeks
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FEV1 %Predicted
Time Frame: Change from Baseline and 12 weeks
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Forced Expiratory Volume in 1 second.
Pulmonary Function Test (PFT).
|
Change from Baseline and 12 weeks
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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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Change from Baseline and 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ryan Harris, Ph.D, Augusta University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
July 30, 2018
Study Completion (Actual)
July 30, 2018
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
May 12, 2016
First Posted (Estimate)
May 17, 2016
Study Record Updates
Last Update Posted (Actual)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 5, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPD-LT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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