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Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01398943
First Posted: July 21, 2011
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Ryan Harris, Augusta University
Results First Submitted: November 17, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow for 3 periods

Period 1:   First Intervention (1 Day)
    COPD: AOC First, Then Placebo   COPD: Placebo First, Then AOC   Controls: AOC First, Then Placebo   Controls: Placebo First, Then AOC
STARTED   15   15   15   15 
COMPLETED   15   15   15   15 
NOT COMPLETED   0   0   0   0 

Period 2:   Washout (2-7 Days)
    COPD: AOC First, Then Placebo   COPD: Placebo First, Then AOC   Controls: AOC First, Then Placebo   Controls: Placebo First, Then AOC
STARTED   15   15   15   15 
COMPLETED   15   15   15   15 
NOT COMPLETED   0   0   0   0 

Period 3:   Second Intervention (1 Day)
    COPD: AOC First, Then Placebo   COPD: Placebo First, Then AOC   Controls: AOC First, Then Placebo   Controls: Placebo First, Then AOC
STARTED   15   15   15   15 
COMPLETED   15   15   15   15 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All COPD Patients Patients with COPD
All Controls Healthy age- and sex- matched controls
Total Total of all reporting groups

Baseline Measures
   All COPD Patients   All Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age, Customized 
[Units: Years]
Mean (Standard Deviation)
     
Age   66  (2)   66  (2)   66  (2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  50.0%      15  50.0%      30  50.0% 
Male      15  50.0%      15  50.0%      30  50.0% 
Height 
[Units: Cm]
Mean (Standard Deviation)
 169  (2)   166  (2)   168  (2) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Flow-Mediated Dilation (FMD)   [ Time Frame: Post FMD was taken approximately 110 min after baseline ]

2.  Secondary:   Pulse Wave Velocity   [ Time Frame: Post PWV was taken approximately 90 min after baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: ryharris@augusta.edu


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: September 13, 2017