Trial Outcomes & Findings for Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01398943)
NCT ID: NCT01398943
Last Updated: 2017-12-11
Results Overview
Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function at baseline and several hours after each experimental intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Post FMD was taken approximately 110 min after baseline
Results posted on
2017-12-11
Participant Flow
Participant milestones
| Measure |
COPD: AOC First, Then Placebo
Patients with COPD
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.
After a minimum of 2 days washout, patients returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo.
|
COPD: Placebo First, Then AOC
Patients with COPD
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.
After a minimum of 2 days washout, patients returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.
|
Controls: AOC First, Then Placebo
Healthy age- and sex- matched controls
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) were assessed at baseline and 2 hours following ingestion of an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.
After a minimum of 2 days washout, subjects returned to perform all measures again but were given microcrystalline cellulose capsules as a placebo.
|
Controls: Placebo First, Then AOC
Brachial artery flow-mediated dilation, direct assessment of oxidative stress via EPR spectroscopy (O2-) and biomarkers of oxidative stress (8-isoprostane, LH, SOD) was assessed at baseline and 2 hours following ingestion of microcrystalline cellulose capsules as a placebo.
After a minimum of 2 days washout, subjects returned to perform all measures again but were given an oral antioxidant cocktail (1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.) Antioxidant Cocktail: 1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid.
|
|---|---|---|---|---|
|
First Intervention (1 Day)
STARTED
|
15
|
15
|
15
|
15
|
|
First Intervention (1 Day)
COMPLETED
|
15
|
15
|
15
|
15
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (2-7 Days)
STARTED
|
15
|
15
|
15
|
15
|
|
Washout (2-7 Days)
COMPLETED
|
15
|
15
|
15
|
15
|
|
Washout (2-7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
15
|
15
|
15
|
15
|
|
Second Intervention (1 Day)
COMPLETED
|
15
|
15
|
15
|
15
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
All COPD Patients
n=30 Participants
Patients with COPD
|
All Controls
n=30 Participants
Healthy age- and sex- matched controls
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
66 years
STANDARD_DEVIATION 2 • n=5 Participants
|
66 years
STANDARD_DEVIATION 2 • n=7 Participants
|
66 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Height
|
169 cm
STANDARD_DEVIATION 2 • n=5 Participants
|
166 cm
STANDARD_DEVIATION 2 • n=7 Participants
|
168 cm
STANDARD_DEVIATION 2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post FMD was taken approximately 110 min after baselinePopulation: Participants included patients diagnosed with COPD and healthy age-matched controls.
Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function at baseline and several hours after each experimental intervention.
Outcome measures
| Measure |
All COPD Patients
n=30 Participants
Patients with COPD
|
All Controls
n=30 Participants
Healthy age- and sex- matched controls
|
|---|---|---|
|
Flow-Mediated Dilation (FMD)
Placebo
|
3.1 percentage of change in FMD
Standard Deviation 0.5
|
6.7 percentage of change in FMD
Standard Deviation 0.6
|
|
Flow-Mediated Dilation (FMD)
AOC Treatment
|
4.7 percentage of change in FMD
Standard Deviation 0.6
|
6.9 percentage of change in FMD
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Post PWV was taken approximately 90 min after baselinePopulation: Patients diagnosed with COPD compared to healthy age-matched controls.
A measure of vascular stiffness at baseline and several hours after each experimental intervention.
Outcome measures
| Measure |
All COPD Patients
n=30 Participants
Patients with COPD
|
All Controls
n=30 Participants
Healthy age- and sex- matched controls
|
|---|---|---|
|
Pulse Wave Velocity
Placebo
|
14 m/sec
Standard Deviation 1
|
11 m/sec
Standard Deviation 2
|
|
Pulse Wave Velocity
AOC Treatment
|
11 m/sec
Standard Deviation 1
|
10 m/sec
Standard Deviation 1
|
Adverse Events
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD Patients
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