Trial · NCT00467896
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
NCT00467896, Phase 2, Terminated, Actelion; results first posted 2012-10-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting. Trials, record NCT00467896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00467896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
- NCT number
- NCT00467896
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Hypertension
- Interventions
- Iloprost PD-6, Iloprost PD-15
- First posted
- 2007-05-01
- Last updated
- 2013-04-04
- Results first posted
- 2012-10-26
- Limitations and caveats
- Study was terminated early due to the discontinuation of the I-neb Power Disc-15 development program.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Inhalation-times Rate - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Primary | Inhalation-times Rate - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Primary | Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15) | 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15 | Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Number of Daily Inhalations - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Number of Daily Inhalations - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Average number of daily inhalations. The number of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Daily Inhalation Duration - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Daily Inhalation Duration - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Average daily inhalation duration. The inhalation duration was available from the I-neb® device, which recorded the date and time of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | The frequency of dose completion was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
| Secondary | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | The frequency of daily inhalations was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full) |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Inhalation-times Rate - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | percentage of full doses administered | MEAN |
| SECONDARY | Number of Daily Inhalations - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | inhalations/day | MEAN |
| SECONDARY | Number of Daily Inhalations - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | inhalations/day | MEAN |
| SECONDARY | Daily Inhalation Duration - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | minutes | MEAN |
| SECONDARY | Daily Inhalation Duration - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | minutes | MEAN |
| SECONDARY | Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | percentage of complete doses | MEAN |
| SECONDARY | Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | percentage of complete doses | MEAN |
| SECONDARY | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | 37 days prior to first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | percentage of daily doses | MEAN |
| PRIMARY | Inhalation-times Rate - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | percentage of full doses administered | MEAN |
| SECONDARY | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) | 37 days following first dose of iloprost PD-15 | Modified intent-to-treat (MITT) population which includes all patients enrolled into the study who had at least 32 consecutive days of daily inhalation times data with PD-6, and at least 6 consecutive days of daily inhalation times data with PD-15. | percentage of daily doses | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Inhalation-times Rate - Iloprost PD-6 (Period I) | Iloprost PD-6 | 29.9 | Standard Deviation 28.75 | percentage of full doses administered | |
| Number of Daily Inhalations - Iloprost PD-6 (Period I) | Iloprost PD-6 | 5.8 | Standard Deviation 1.22 | inhalations/day | |
| Number of Daily Inhalations - Iloprost PD-15 (Period II) | Iloprost PD-15 | 6.0 | Standard Deviation 1.11 | inhalations/day | |
| Daily Inhalation Duration - Iloprost PD-6 (Period I) | Iloprost PD-6 | 15.0 | Standard Deviation 5.48 | minutes | |
| Daily Inhalation Duration - Iloprost PD-15 (Period II) | Iloprost PD-15 | 7.2 | Standard Deviation 2.17 | minutes | |
| Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | Iloprost PD-6 | 83.1 | Standard Deviation 21.18 | percentage of complete doses | |
| Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | Iloprost PD-15 | 98.0 | Standard Deviation 3.42 | percentage of complete doses | |
| Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | Iloprost PD-6 | 55.1 | Standard Deviation 29.53 | percentage of daily doses | |
| Inhalation-times Rate - Iloprost PD-15 (Period II) | Iloprost PD-15 | 79.7 | Standard Deviation 17.45 | percentage of full doses administered | |
| Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) | Iloprost PD-15 | 66.1 | Standard Deviation 21.2 | percentage of daily doses |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Iloprost | 62 | |
| Overall Study | COMPLETED | Iloprost | 11 | |
| Overall Study | NOT COMPLETED | Iloprost | 51 |
Source ClinicalTrials.gov
Adverse events73
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pulmonary Arterial Hypertension | Respiratory, thoracic and mediastinal disorders | Iloprost PD-15 | 18 | 62 | |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Iloprost PD-15 | 13 | 62 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Iloprost PD-15 | 9 | 62 | |
| other | Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Iloprost PD-15 | 9 | 62 | |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Iloprost PD-15 | 5 | 62 | |
| other | Headache | Nervous system disorders | Iloprost PD-15 | 7 | 62 | |
| other | Syncope | Nervous system disorders | Iloprost PD-15 | 6 | 62 | |
| other | Sinusitis | Infections and infestations | Iloprost PD-15 | 8 | 62 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Iloprost PD-15 | 7 | 62 | |
| other | Urinary Tract Infection | Infections and infestations | Iloprost PD-15 | 5 | 62 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iloprost PD-15 | ||
| Total, other adverse events | Iloprost PD-15 | 53 | 62 |
| Total, serious adverse events | Iloprost PD-15 | 27 | 62 |
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 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/NCT00467896
GET https://conductscience.org/api/trials/v1/NCT00467896/results?page=2