Trial · NCT02774226
Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
NCT02774226, Phase 2, Completed, Augusta University; results first posted 2021-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease. Trials, record NCT02774226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02774226
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease
- NCT number
- NCT02774226
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Tetrahydrobiopterin (BH4), Antioxidant Cocktail
- First posted
- 2016-05-17
- Last updated
- 2021-02-23
- Results first posted
- 2021-02-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Flow Mediated Dilation | Change from Baseline and 12 weeks | Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and 12 weeks after treatment. |
| Secondary | Change in PWV (Pulse Wave Velocity) | 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. |
| Secondary | FEV1 %Predicted | Change from Baseline and 12 weeks | Forced Expiratory Volume in 1 second. Pulmonary Function Test (PFT). |
| Secondary | Percent of ACH to Heat Max | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Flow Mediated Dilation | Change from Baseline and 12 weeks | Data was not usable on one participant in the antioxidant group. Too much artifact. | percentage of flow mediated dilation | MEAN |
| SECONDARY | Change in PWV (Pulse Wave Velocity) | Change from Baseline and 12 weeks | Unable to obtain pulse wave on 2 participants in the AOX group. | m/s | MEAN |
| SECONDARY | FEV1 %Predicted | Change from Baseline and 12 weeks | Unable to obtain valid lung function on one participant in the BH4 group as well as one participant in the AOX group. | percentage of predicted | MEAN |
| SECONDARY | Percent of ACH to Heat Max | Change from Baseline and 12 weeks | percent | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Flow Mediated Dilation | Tetrahydrobiopterin (BH4) | 0.26 | Standard Deviation 2.57 | percentage of flow mediated dilation | |
| Change in Flow Mediated Dilation | Antioxidant Cocktail | -1.5 | Standard Deviation 3.86 | percentage of flow mediated dilation | |
| Change in PWV (Pulse Wave Velocity) | Tetrahydrobiopterin (BH4) | -0.36 | Standard Deviation 0.66 | m/s | |
| Change in PWV (Pulse Wave Velocity) | Antioxidant Cocktail | 0.34 | Standard Deviation 0.86 | m/s | |
| FEV1 %Predicted | Tetrahydrobiopterin (BH4) | -3.6 | Standard Deviation 6.3 | percentage of predicted | |
| FEV1 %Predicted | Antioxidant Cocktail | -4.2 | Standard Deviation 10.9 | percentage of predicted | |
| Percent of ACH to Heat Max | Tetrahydrobiopterin (BH4) | 4.2 | Standard Deviation 15 | percent | |
| Percent of ACH to Heat Max | Antioxidant Cocktail | -0.8 | Standard Deviation 41.6 | percent |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tetrahydrobiopterin (BH4) | 8 | |
| Overall Study | STARTED | Antioxidant Cocktail | 7 | |
| Overall Study | COMPLETED | Tetrahydrobiopterin (BH4) | 8 | |
| Overall Study | COMPLETED | Antioxidant Cocktail | 7 | |
| Overall Study | NOT COMPLETED | Tetrahydrobiopterin (BH4) | 0 | |
| Overall Study | NOT COMPLETED | Antioxidant Cocktail | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tetrahydrobiopterin (BH4) | 0 | 8 |
| Total, all-cause mortality | Antioxidant Cocktail | 0 | 7 |
| Total, other adverse events | Tetrahydrobiopterin (BH4) | 0 | 8 |
| Total, other adverse events | Antioxidant Cocktail | 0 | 7 |
| Total, serious adverse events | Tetrahydrobiopterin (BH4) | 0 | 8 |
| Total, serious adverse events | Antioxidant Cocktail | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tetrahydrobiopterin (BH4) vs Antioxidant Cocktail: deaths from any cause | Trial comparisons |
| Tetrahydrobiopterin (BH4) vs Antioxidant Cocktail: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02774226
GET https://conductscience.org/api/trials/v1/NCT02774226/registered