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Sponsor's decision
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A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iloprost | Experimental | The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost PD-6 | Drug | Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®. |
| Measure | Description | Time Frame |
|---|---|---|
| Inhalation-times Rate - Iloprost PD-6 (Period I) | 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) | 37 days prior to first dose of iloprost PD-15 |
| Inhalation-times Rate - Iloprost PD-15 (Period II) | 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) | 37 days following first dose of iloprost PD-15 |
| Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (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) | 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Daily Inhalations - Iloprost PD-6 (Period I) | 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) | 37 days prior to first dose of iloprost PD-15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Mathier, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Ramagopal Tumuluri, MD | Aurora Medical Group - Cardiovascular Services | Principal Investigator |
| Charles J. Burch, MD | Diagnostic Research Group | Principal Investigator |
| David Baratz, MD | Pulmonary Associates | Principal Investigator |
| Ben DeBoisblanc, MD | Ochsner Health System | Principal Investigator |
| Adaani Frost, MD | Baylor College of Medicine | Principal Investigator |
| Victor Test, MD | UCSD Medical Center, Thorton Hospital | Principal Investigator |
| Sif Handsdottir, MD | University of Iowa Hospital & Clinics | Principal Investigator |
| Myung Park, MD | University of Maryland Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Phoenix | Arizona | 85006 | United States | ||
| UCSD Medical Center, Thorton Hospital |
Adults with symptomatic pulmonary arterial hypertension (PAH) who were using Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 (PD-6) were enrolled
Patients were enrolled across 12 U.S. centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iloprost | iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Iloprost PD-15 | Drug | Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®. |
|
|
| Number of Daily Inhalations - Iloprost PD-15 (Period II) | 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) | 37 days following first dose of iloprost PD-15 |
| Daily Inhalation Duration - Iloprost PD-6 (Period I) | 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) | 37 days prior to first dose of iloprost PD-15 |
| Daily Inhalation Duration - Iloprost PD-15 (Period II) | 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) | 37 days following first dose of iloprost PD-15 |
| Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | 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) | 37 days prior to first dose of iloprost PD-15 |
| Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | 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) | 37 days following first dose of iloprost PD-15 |
| Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | 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) | 37 days prior to first dose of iloprost PD-15 |
| Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) | 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) | 37 days following first dose of iloprost PD-15 |
| Systolic Blood Pressure - Iloprost PD-6 (Period I) | SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | Day 1, prior to first dose of iloprost PD-15 |
| Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | Day 1 and Day 7, following the first dose of iloprost PD-15 |
| Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | Day 1, prior to first dose of iloprost PD-15 |
| Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | Day 1 and Day 7, following the first dose of iloprost PD-15 |
| Heart Rate (HR) - Iloprost PD-6 (Period I) | HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | Day 1, prior to first dose of iloprost PD-15 |
| Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | Day 1 and Day 7, following the first dose of iloprost PD-15 |
| Evelyn Horn, MD |
| New York Presbyterian Hospital |
| Principal Investigator |
| Erika Berman-Rosenzweig, MD | Columbia University | Principal Investigator |
| Victor Tapson, MD | Duke University | Principal Investigator |
| La Jolla |
| California |
| 92037 |
| United States |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | 52242 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70112 | United States |
| University of Maryland Hospital | Baltimore | Maryland | 21201 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| New York Presbyterian Hospital | New York | New York | 10032 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Diagnostic Research Group | San Antonio | Texas | 78229 | United States |
| Aurora Medical Group - Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iloprost | iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inhalation-times Rate - Iloprost PD-6 (Period I) | 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) | 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. | Posted | Mean | Standard Deviation | percentage of full doses administered | 37 days prior to first dose of iloprost PD-15 |
|
|
| |||||||||||||||||||||||||
| Secondary | Number of Daily Inhalations - Iloprost PD-6 (Period I) | 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) | 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. | Posted | Mean | Standard Deviation | inhalations/day | 37 days prior to first dose of iloprost PD-15 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Daily Inhalations - Iloprost PD-15 (Period II) | 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) | 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. | Posted | Mean | Standard Deviation | inhalations/day | 37 days following first dose of iloprost PD-15 |
|
| ||||||||||||||||||||||||||
| Secondary | Daily Inhalation Duration - Iloprost PD-6 (Period I) | 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) | 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. | Posted | Mean | Standard Deviation | minutes | 37 days prior to first dose of iloprost PD-15 |
|
| ||||||||||||||||||||||||||
| Secondary | Daily Inhalation Duration - Iloprost PD-15 (Period II) | 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) | 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. | Posted | Mean | Standard Deviation | minutes | 37 days following first dose of iloprost PD-15 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | 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) | 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. | Posted | Mean | Standard Deviation | percentage of complete doses | 37 days prior to first dose of iloprost PD-15 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | 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) | 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. | Posted | Mean | Standard Deviation | percentage of complete doses | 37 days following first dose of iloprost PD-15 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | 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) | 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. | Posted | Mean | Standard Deviation | percentage of daily doses | 37 days prior to first dose of iloprost PD-15 |
|
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| Primary | Inhalation-times Rate - Iloprost PD-15 (Period II) | 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) | 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. | Posted | Mean | Standard Deviation | percentage of full doses administered | 37 days following first dose of iloprost PD-15 |
|
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| Secondary | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) | 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) | 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. | Posted | Mean | Standard Deviation | percentage of daily doses | 37 days following first dose of iloprost PD-15 |
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| Secondary | Systolic Blood Pressure - Iloprost PD-6 (Period I) | SBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | safety population | Posted | Mean | Standard Deviation | mmHg | Day 1, prior to first dose of iloprost PD-15 |
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| Secondary | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | SBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | safety population | Posted | Mean | Standard Deviation | mmHg | Day 1 and Day 7, following the first dose of iloprost PD-15 |
|
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| Secondary | Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | DBP was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | safety population | Posted | Mean | Standard Deviation | mmHg | Day 1, prior to first dose of iloprost PD-15 |
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| Secondary | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | DBP was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | safety population | Posted | Mean | Standard Deviation | mmHg | Day 1 and Day 7, following the first dose of iloprost PD-15 |
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| Secondary | Heart Rate (HR) - Iloprost PD-6 (Period I) | HR was recorded on Day 1 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-6 | safety population | Posted | Mean | Standard Deviation | beats per minute | Day 1, prior to first dose of iloprost PD-15 |
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| Secondary | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | HR was recorded on Day 1 and Day 7 at 3 different timepoints: pre-inhalation, immediately post-inhalation and 15 minutes after inhalation of iloprost using PD-15 | safety population | Posted | Mean | Standard Deviation | beats per minute | Day 1 and Day 7, following the first dose of iloprost PD-15 |
|
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| Primary | Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (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) | 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. | Posted | Mean | Standard Deviation | percentage of full doses administered | 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15 |
|
|
Adverse events were collected from baseline visit to end of study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iloprost PD-15 | iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15). | 27 | 62 | 53 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Arterial Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Acute Right Ventricular Failure | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrial Tachycardia | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Reflux Oesophagitis | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Pancreatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Heparin-Induced Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Therapeutic Agent Toxicity | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Arterial Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Fluid Retention | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Systematic Assessment |
|
Study was terminated early due to the discontinuation of the I-neb Power Disc-15 development program.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wade Benton, Pharm D / Director, Medical Affairs Veletri and Ventavis | Actelion Pharmaceuticals, US, Inc. | (650) 624-6900 | wade.benton@actelion.com |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016285 | Iloprost |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| pre-dose |
| |||||
| immediately post-dose |
| |||||
| 15 minutes post dose |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| pre-dose |
| |||||
| immediately post-dose |
| |||||
| 15 minutes post-dose |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| pre-dose |
| |||||
| immediately post-dose |
| |||||
| 15 minutes post-dose |
|
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