Trial · NCT02057458
Blood Flow and Vascular Function in Cystic Fibrosis
NCT02057458, Phase 2, Completed, Augusta University; results first posted 2020-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Blood Flow and Vascular Function in Cystic Fibrosis. Trials, record NCT02057458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02057458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blood Flow and Vascular Function in Cystic Fibrosis
- NCT number
- NCT02057458
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Augusta University
- Conditions
- Cystic Fibrosis
- Interventions
- Sildenafil (Acute-1 hour), Sildenafil (Subchronic-4 weeks), Placebo
- First posted
- 2014-02-07
- Last updated
- 2020-04-24
- Results first posted
- 2020-04-24
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute Study: Percentage Flow-Mediated Dilation (FMD) | pre-treatment Baseline and 1 hour post-treatment | FMD determined one hour after ingestion of 50 mg Sildenafil or placebo |
| Primary | Baseline Diameter | pre-treatment Baseline and following 4 weeks sub-chronic treatment | Brachial Artery Diameter during FMD (pre-occlusion or "baseline") |
| Primary | Peak Diameter | pre-treatment Baseline and following 4 weeks sub-chronic treatment | Peak Brachial Artery Diameter during FMD (post-occlusion) |
| Primary | Absolute Change in Diameter | pre-treatment Baseline and following 4 weeks sub-chronic treatment | Absolute change in brachial artery diameter taken from the FMD assessment |
| Primary | FEV1 (% Predicted) | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | Forced Expiratory Volume in the first second expressed as a percent predicted. |
| Primary | VO2 Peak (Absolute) | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | absolute (L/min) peak oxygen consumption during maximal exercise test |
| Primary | VO2 Peak (Relative) | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | relative (mL/kg/min) peak oxygen consumption during maximal exercise test |
| Primary | VO2 Peak (Percent Predicted) | pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment | Maximal Oxygen consumption expressed as percent predicted taken from maximal exercise test. |
| Primary | VE Peak | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | peak ventilation (L/min) during maximal exercise test |
| Primary | RER Peak | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | peak respiratory exchange ratio during maximal exercise test |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Acute Study: Percentage Flow-Mediated Dilation (FMD) | pre-treatment Baseline and 1 hour post-treatment | percent flow mediated dilation | MEAN | |
| PRIMARY | Baseline Diameter | pre-treatment Baseline and following 4 weeks sub-chronic treatment | mm | MEAN | |
| PRIMARY | Peak Diameter | pre-treatment Baseline and following 4 weeks sub-chronic treatment | mm | MEAN | |
| PRIMARY | Absolute Change in Diameter | pre-treatment Baseline and following 4 weeks sub-chronic treatment | mm | MEAN | |
| PRIMARY | FEV1 (% Predicted) | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | percent predicted | MEAN | |
| PRIMARY | VO2 Peak (Absolute) | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | L/min | MEAN | |
| PRIMARY | VO2 Peak (Relative) | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | mL/kg/min | MEAN | |
| PRIMARY | VO2 Peak (Percent Predicted) | pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment | percent predicted | MEAN | |
| PRIMARY | VE Peak | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | L/min | MEAN | |
| PRIMARY | RER Peak | pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment | ratio | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Acute Study: Percentage Flow-Mediated Dilation (FMD) | Acute Study: Sildenafil | Pre | 7.8 | Standard Deviation 4.3 | percent flow mediated dilation |
| Acute Study: Percentage Flow-Mediated Dilation (FMD) | Acute Study: Placebo | Pre | 7.7 | Standard Deviation 4.3 | percent flow mediated dilation |
| Acute Study: Percentage Flow-Mediated Dilation (FMD) | Acute Study: Sildenafil | Post | 7.3 | Standard Deviation 4.8 | percent flow mediated dilation |
| Acute Study: Percentage Flow-Mediated Dilation (FMD) | Acute Study: Placebo | Post | 6.6 | Standard Deviation 3.7 | percent flow mediated dilation |
| Baseline Diameter | Baseline | 3.00 | Standard Deviation 0.59 | mm | |
| Baseline Diameter | Sub-chronic Study: Sildenafil | 3.06 | Standard Deviation 0.60 | mm | |
| Peak Diameter | Baseline | 3.22 | Standard Deviation 0.60 | mm | |
| Peak Diameter | Sub-chronic Study: Sildenafil | 3.30 | Standard Deviation 0.60 | mm | |
| Absolute Change in Diameter | Baseline | 0.21 | Standard Deviation 0.12 | mm | |
| Absolute Change in Diameter | Sub-chronic Study: Sildenafil | 0.27 | Standard Deviation 0.09 | mm |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Recruited for Participation | STARTED | Acute Study: Sildenafil First, Then Placebo | 8 | |
| Recruited for Participation | STARTED | Acute Study: Placebo First, Then Sildenafil | 8 | |
| Recruited for Participation | STARTED | Sub-Chronic Only | 3 | |
| Recruited for Participation | COMPLETED | Acute Study: Sildenafil First, Then Placebo | 8 | |
| Recruited for Participation | COMPLETED | Acute Study: Placebo First, Then Sildenafil | 8 | |
| Recruited for Participation | COMPLETED | Sub-Chronic Only | 3 | |
| Recruited for Participation | NOT COMPLETED | Acute Study: Sildenafil First, Then Placebo | 0 | |
| Recruited for Participation | NOT COMPLETED | Acute Study: Placebo First, Then Sildenafil | 0 | |
| Recruited for Participation | NOT COMPLETED | Sub-Chronic Only | 0 | |
| Met Inclusion Criteria | STARTED | Acute Study: Sildenafil First, Then Placebo | 8 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Study | 0 | 18 |
| Total, other adverse events | Overall Study | 0 | 18 |
| Total, serious adverse events | Overall Study | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33105385 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DK100783 | Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis | HARRIS, RYAN A | AUGUSTA UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2014 to 2015 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02057458
GET https://conductscience.org/api/trials/v1/NCT02057458/results?page=2