Trial · NCT02170519
Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
NCT02170519, Phase 4, Terminated, Duke University; results first posted 2014-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide. Trials, record NCT02170519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02170519
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled Aerosolized Prostacyclin for Pulmonary Hypertension Requiring Inhaled Nitric Oxide
- NCT number
- NCT02170519
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 27 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Pulmonary Hypertension
- Interventions
- Inhaled Iloprost
- First posted
- 2014-06-23
- Last updated
- 2024-10-15
- Results first posted
- 2014-08-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Oxygen Saturation (SpO2) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | Readings were taken from the medical record and the data may not have been present at the exact time frames. |
| Primary | Percent Change in Oxygen Saturation (SpO2) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | |
| Primary | Change in Mean Heart Rate From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | |
| Primary | Change in Mean Heart Rate From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | |
| Primary | Number of Treatment Failures | as long as subject was on drug up to approximately 24 hours | Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: 1. Cardiac Index (CI) \>/= 1.8 L/min/m2 2. Administration of \>/=0.1 ug/kg/min Epinephrine or Norepinephrine 3. MAP \</= 50 mmHg (or as appropriate for age in pediatrics). 4. SvO2\</= 55% (or \< 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.} |
| Primary | Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | |
| Primary | Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | |
| Secondary | Change in Cardiac Output (CO) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | |
| Secondary | Change in Cardiac Output (CO) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | |
| Secondary | Change in Mean Venous Oxygen Saturation (SvO2) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Oxygen Saturation (SpO2) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | Phase 2 subjects | percent change | MEAN |
| PRIMARY | Percent Change in Oxygen Saturation (SpO2) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | Phase 1 subjects | percent change | MEAN |
| PRIMARY | Change in Mean Heart Rate From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | Phase 2 subjects | percent change | MEAN |
| PRIMARY | Change in Mean Heart Rate From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | Phase 1 subjects | percent change | MEAN |
| SECONDARY | Change in Cardiac Output (CO) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable. | percent change | MEAN |
| SECONDARY | Change in Cardiac Output (CO) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | Phase 1 subjects | percent change | MEAN |
| PRIMARY | Number of Treatment Failures | as long as subject was on drug up to approximately 24 hours | participants | NUMBER | |
| PRIMARY | Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter. | percent change | MEAN |
| PRIMARY | Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline | dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour) | Phase 1 subjects | percent change | MEAN |
| SECONDARY | Change in Mean Venous Oxygen Saturation (SvO2) From Baseline | 30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours | Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable. | percent change | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 30 mins after initial dose | -0.4 | Standard Deviation 1.7 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 2 hours | -0.8 | Standard Deviation 2.8 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 4 hours | -1.2 | Standard Deviation 2.9 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 6 hours | -0.2 | Standard Deviation 3.6 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 8 hours | -0.7 | Standard Deviation 3.1 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 10 hours | -0.9 | Standard Deviation 3.0 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 12 hours | -0.9 | Standard Deviation 3.7 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 18 hours | -1.5 | Standard Deviation 5.6 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 2: Inhaled Iloprost Continuous | 24 hours | 1.7 | Standard Deviation 6.4 | percent change |
| Percent Change in Oxygen Saturation (SpO2) From Baseline | Phase 1: Inhaled Iloprost 3 Doses | dose 1 | -0.4 | Standard Deviation 0.6 | percent change |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 2: Inhaled Iloprost Continuous | 22 | |
| Overall Study | STARTED | Phase 1: Inhaled Iloprost 3 Doses | 5 | |
| Overall Study | COMPLETED | Phase 2: Inhaled Iloprost Continuous | 22 | |
| Overall Study | COMPLETED | Phase 1: Inhaled Iloprost 3 Doses | 5 | |
| Overall Study | NOT COMPLETED | Phase 2: Inhaled Iloprost Continuous | 0 | |
| Overall Study | NOT COMPLETED | Phase 1: Inhaled Iloprost 3 Doses | 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 | Phase 2: Inhaled Iloprost Continuous | ||
| Total, all-cause mortality | Phase 1: Inhaled Iloprost 3 Doses | ||
| Total, other adverse events | Phase 2: Inhaled Iloprost Continuous | 0 | 22 |
| Total, other adverse events | Phase 1: Inhaled Iloprost 3 Doses | 0 | 5 |
| Total, serious adverse events | Phase 2: Inhaled Iloprost Continuous | 0 | 22 |
| Total, serious adverse events | Phase 1: Inhaled Iloprost 3 Doses | 0 | 5 |
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 |
|---|---|
| Phase 2: Inhaled Iloprost Continuous vs Phase 1: Inhaled Iloprost 3 Doses: Number of Treatment Failures | Trial comparisons |
| Phase 2: Inhaled Iloprost Continuous vs Phase 1: Inhaled Iloprost 3 Doses: 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/NCT02170519
GET https://conductscience.org/api/trials/v1/NCT02170519/results?page=2