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Trial record 2 of 2 for:    9036757 [PUBMED-IDS]

Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT01398943
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : July 25, 2017
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Ryan Harris, Augusta University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: Tetrahydrobiopterin (BH4)
Dietary Supplement: Antioxidant Cocktail
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title COPD: AOC First, Then Placebo COPD: Placebo First, Then AOC Controls: AOC First, Then Placebo Controls: Placebo First, Then AOC
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: First Intervention (1 Day)
Started 15 15 15 15
Completed 15 15 15 15
Not Completed 0 0 0 0
Period Title: Washout (2-7 Days)
Started 15 15 15 15
Completed 15 15 15 15
Not Completed 0 0 0 0
Period Title: Second Intervention (1 Day)
Started 15 15 15 15
Completed 15 15 15 15
Not Completed 0 0 0 0
Arm/Group Title All COPD Patients All Controls Total
Hide Arm/Group Description Patients with COPD Healthy age- and sex- matched controls Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 30 participants 30 participants 60 participants
66  (2) 66  (2) 66  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
15
  50.0%
15
  50.0%
30
  50.0%
Male
15
  50.0%
15
  50.0%
30
  50.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 30 participants 30 participants 60 participants
169  (2) 166  (2) 168  (2)
1.Primary Outcome
Title Flow-Mediated Dilation (FMD)
Hide Description Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function at baseline and several hours after each experimental intervention.
Time Frame Post FMD was taken approximately 110 min after baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants included patients diagnosed with COPD and healthy age-matched controls.
Arm/Group Title All COPD Patients All Controls
Hide Arm/Group Description:
Patients with COPD
Healthy age- and sex- matched controls
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percentage of change in FMD
Placebo 3.1  (0.5) 6.7  (0.6)
AOC Treatment 4.7  (0.6) 6.9  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All COPD Patients
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Pulse Wave Velocity
Hide Description A measure of vascular stiffness at baseline and several hours after each experimental intervention.
Time Frame Post PWV was taken approximately 90 min after baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients diagnosed with COPD compared to healthy age-matched controls.
Arm/Group Title All COPD Patients All Controls
Hide Arm/Group Description:

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) will be assessed at baseline and 2 hours following ingestion of a single 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

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) will be assessed at baseline and 2 hours following ingestion of a single 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

Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: m/sec
Placebo 14  (1) 11  (2)
AOC Treatment 11  (1) 10  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All COPD Patients
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Controls
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title COPD Patients Controls
Hide Arm/Group Description

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) will be assessed at baseline and 2 hours following ingestion of a single 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

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) will be assessed at baseline and 2 hours following ingestion of a single 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

All-Cause Mortality
COPD Patients Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
COPD Patients Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
COPD Patients Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ryan Harris, Ph.D.
Organization: Augusta University
Phone: 706-721-5998
Publications:
Responsible Party: Ryan Harris, Augusta University
ClinicalTrials.gov Identifier: NCT01398943     History of Changes
Other Study ID Numbers: AHA00115CS
First Submitted: July 19, 2011
First Posted: July 21, 2011
Results First Submitted: November 17, 2016
Results First Posted: July 25, 2017
Last Update Posted: December 11, 2017