Trial Outcomes & Findings for Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease (NCT NCT02774226)
NCT ID: NCT02774226
Last Updated: 2021-02-23
Results Overview
Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and 12 weeks after treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Change from Baseline and 12 weeks
Results posted on
2021-02-23
Participant Flow
Participant milestones
| Measure |
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.
Tetrahydrobiopterin (BH4): 12 week intervention
|
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.
Antioxidant Cocktail: 12 week intervention
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Tetrahydrobiopterin (BH4)
n=8 Participants
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.
Tetrahydrobiopterin (BH4): 12 week intervention
|
Antioxidant Cocktail
n=7 Participants
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.
Antioxidant Cocktail: 12 week intervention
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 5 • n=39 Participants
|
57 years
STANDARD_DEVIATION 6 • n=41 Participants
|
59 years
STANDARD_DEVIATION 5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline and 12 weeksPopulation: Data was not usable on one participant in the antioxidant group. Too much artifact.
Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and 12 weeks after treatment.
Outcome measures
| Measure |
Tetrahydrobiopterin (BH4)
n=8 Participants
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.
Tetrahydrobiopterin (BH4): 12 week intervention
|
Antioxidant Cocktail
n=6 Participants
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.
Antioxidant Cocktail: 12 week intervention
|
|---|---|---|
|
Change in Flow Mediated Dilation
|
0.26 percentage of flow mediated dilation
Standard Deviation 2.57
|
-1.5 percentage of flow mediated dilation
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Change from Baseline and 12 weeksPopulation: Unable to obtain pulse wave on 2 participants in the AOX group.
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.
Outcome measures
| Measure |
Tetrahydrobiopterin (BH4)
n=8 Participants
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.
Tetrahydrobiopterin (BH4): 12 week intervention
|
Antioxidant Cocktail
n=5 Participants
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.
Antioxidant Cocktail: 12 week intervention
|
|---|---|---|
|
Change in PWV (Pulse Wave Velocity)
|
-0.36 m/s
Standard Deviation 0.66
|
0.34 m/s
Standard Deviation 0.86
|
SECONDARY outcome
Timeframe: Change from Baseline and 12 weeksPopulation: Unable to obtain valid lung function on one participant in the BH4 group as well as one participant in the AOX group.
Forced Expiratory Volume in 1 second. Pulmonary Function Test (PFT).
Outcome measures
| Measure |
Tetrahydrobiopterin (BH4)
n=7 Participants
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.
Tetrahydrobiopterin (BH4): 12 week intervention
|
Antioxidant Cocktail
n=6 Participants
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.
Antioxidant Cocktail: 12 week intervention
|
|---|---|---|
|
FEV1 %Predicted
|
-3.6 percentage of predicted
Standard Deviation 6.3
|
-4.2 percentage of predicted
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: Change from Baseline and 12 weeksThe 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).
Outcome measures
| Measure |
Tetrahydrobiopterin (BH4)
n=8 Participants
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.
Tetrahydrobiopterin (BH4): 12 week intervention
|
Antioxidant Cocktail
n=7 Participants
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.
Antioxidant Cocktail: 12 week intervention
|
|---|---|---|
|
Percent of ACH to Heat Max
|
4.2 percent
Standard Deviation 15
|
-0.8 percent
Standard Deviation 41.6
|
Adverse Events
Tetrahydrobiopterin (BH4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antioxidant Cocktail
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place