Trial · NCT01398943
Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)
NCT01398943, Not applicable, Completed, Augusta University; results first posted 2017-07-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT01398943. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01398943
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT01398943
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 60 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Tetrahydrobiopterin (BH4), Antioxidant Cocktail
- First posted
- 2011-07-21
- Last updated
- 2017-12-11
- Results first posted
- 2017-07-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Flow-Mediated Dilation (FMD) | Post FMD was taken approximately 110 min after baseline | Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function at baseline and several hours after each experimental intervention. |
| Secondary | Pulse Wave Velocity | Post PWV was taken approximately 90 min after baseline | A measure of vascular stiffness at baseline and several hours after each experimental intervention. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Flow-Mediated Dilation (FMD) | Post FMD was taken approximately 110 min after baseline | Participants included patients diagnosed with COPD and healthy age-matched controls. | percentage of change in FMD | MEAN |
| SECONDARY | Pulse Wave Velocity | Post PWV was taken approximately 90 min after baseline | Patients diagnosed with COPD compared to healthy age-matched controls. | m/sec | 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 |
|---|---|---|---|---|---|
| Flow-Mediated Dilation (FMD) | All COPD Patients | Placebo | 3.1 | Standard Deviation 0.5 | percentage of change in FMD |
| Flow-Mediated Dilation (FMD) | All Controls | Placebo | 6.7 | Standard Deviation 0.6 | percentage of change in FMD |
| Flow-Mediated Dilation (FMD) | All COPD Patients | AOC Treatment | 4.7 | Standard Deviation 0.6 | percentage of change in FMD |
| Flow-Mediated Dilation (FMD) | All Controls | AOC Treatment | 6.9 | Standard Deviation 0.7 | percentage of change in FMD |
| Pulse Wave Velocity | All COPD Patients | Placebo | 14 | Standard Deviation 1 | m/sec |
| Pulse Wave Velocity | All Controls | Placebo | 11 | Standard Deviation 2 | m/sec |
| Pulse Wave Velocity | All COPD Patients | AOC Treatment | 11 | Standard Deviation 1 | m/sec |
| Pulse Wave Velocity | All Controls | AOC Treatment | 10 | Standard Deviation 1 | m/sec |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention (1 Day) | STARTED | COPD: AOC First, Then Placebo | 15 | |
| First Intervention (1 Day) | STARTED | COPD: Placebo First, Then AOC | 15 | |
| First Intervention (1 Day) | STARTED | Controls: AOC First, Then Placebo | 15 | |
| First Intervention (1 Day) | STARTED | Controls: Placebo First, Then AOC | 15 | |
| First Intervention (1 Day) | COMPLETED | COPD: AOC First, Then Placebo | 15 | |
| First Intervention (1 Day) | COMPLETED | COPD: Placebo First, Then AOC | 15 | |
| First Intervention (1 Day) | COMPLETED | Controls: AOC First, Then Placebo | 15 | |
| First Intervention (1 Day) | COMPLETED | Controls: Placebo First, Then AOC | 15 | |
| First Intervention (1 Day) | NOT COMPLETED | COPD: AOC First, Then Placebo | 0 | |
| First Intervention (1 Day) | NOT COMPLETED | COPD: Placebo First, Then AOC | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse 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 | COPD Patients | ||
| Total, all-cause mortality | Controls | ||
| Total, other adverse events | COPD Patients | 0 | 30 |
| Total, other adverse events | Controls | 0 | 30 |
| Total, serious adverse events | COPD Patients | 0 | 30 |
| Total, serious adverse events | Controls | 0 | 30 |
Source ClinicalTrials.gov
Papers62
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| COPD Patients vs Controls: serious adverse events |
Source 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/NCT01398943
GET https://conductscience.org/api/trials/v1/NCT01398943/flow?page=2