Pulmonary Hypertension
Conditions
Keywords
PAH, iloprost, Ventavis, Pulmonary Arterial Hypertension, Actelion Pharmaceuticals, Cotherix
Brief summary
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
Interventions
DRUGIloprost PD-6
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®.
DRUGIloprost PD-15
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®.
Sponsors
Actelion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18-85 years * Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine) * On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6
Exclusion criteria
* Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit * Receipt of atrial septostomy within the 6 months preceding Screening * History of left-sided heart disease * Clinically relevant obstructive lung disease * Chronic renal or liver disease * Uncontrolled systemic hypertension or hypotension * Cerebrovascular event within the 6 months preceding Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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 | 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) |
| 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) |
| Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | Day 1 and Day 7, following the first dose of iloprost PD-15 | 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 |
| Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | Day 1, prior to first dose of iloprost PD-15 | 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 |
| Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | Day 1 and Day 7, following the first dose of iloprost PD-15 | 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 |
| Heart Rate (HR) - Iloprost PD-6 (Period I) | Day 1, prior to first dose of iloprost PD-15 | 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 |
| Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | Day 1 and Day 7, following the first dose of iloprost PD-15 | 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 |
| Systolic Blood Pressure - Iloprost PD-6 (Period I) | Day 1, prior to first dose of iloprost PD-15 | 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 |
| 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) |
| 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) |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled across 12 U.S. centers.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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). | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Changed therapy | 2 |
| Overall Study | Consent Withdrawal | 18 |
| Overall Study | Mainly used Prodose not I-neb® device | 1 |
| Overall Study | Non-compliance | 3 |
| Overall Study | Patient had atrial septostomy | 1 |
| Overall Study | Patient had no improvement | 1 |
| Overall Study | Patient received transplant | 2 |
| Overall Study | Patient weaned off iloprost | 1 |
| Overall Study | Serious Adverse Event | 13 |
| Overall Study | Started inhaled Remodulin | 1 |
| Overall Study | Started intravenous prostacyclin | 1 |
Baseline characteristics
| Characteristic | Iloprost |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age Continuous | 52.5 years STANDARD_DEVIATION 14.87 |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / 62 |
| serious Total, serious adverse events | 27 / 62 |
Outcome results
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)
Time frame: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15) | 49.8 percentage of full doses administered | Standard Deviation 34.28 |
Comparison: Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)p-value: <0.000195% CI: [39.55, 60.15]t-test, 2 sided
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)
Time frame: 37 days following first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Inhalation-times Rate - Iloprost PD-15 (Period II) | 79.7 percentage of full doses administered | Standard Deviation 17.45 |
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)
Time frame: 37 days prior to first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Inhalation-times Rate - Iloprost PD-6 (Period I) | 29.9 percentage of full doses administered | Standard Deviation 28.75 |
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)
Time frame: 37 days following first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Daily Inhalation Duration - Iloprost PD-15 (Period II) | 7.2 minutes | Standard Deviation 2.17 |
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)
Time frame: 37 days prior to first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Daily Inhalation Duration - Iloprost PD-6 (Period I) | 15.0 minutes | Standard Deviation 5.48 |
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
Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15
Population: safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | pre-dose (Day 1) | 67.5 mmHg | Standard Deviation 10.44 |
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | immediately post-dose (Day 1) | 65.2 mmHg | Standard Deviation 8.72 |
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | 15 minutes post-dose (Day 1) | 67.9 mmHg | Standard Deviation 11.16 |
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | pre-dose (Day 7) | 68.6 mmHg | Standard Deviation 11.22 |
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | immediately post-dose (Day 7) | 65.7 mmHg | Standard Deviation 11.34 |
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | 15 minutes post-dose (Day 7) | 66.7 mmHg | Standard Deviation 11.52 |
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
Time frame: Day 1, prior to first dose of iloprost PD-15
Population: safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | 15 minutes post-dose | 66.6 mmHg | Standard Deviation 9.79 |
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | pre-dose | 68.6 mmHg | Standard Deviation 10.94 |
| Iloprost PD-6 | Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I) | immediately post-dose | 65.6 mmHg | Standard Deviation 8.98 |
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
Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15
Population: safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | 15 minutes post-dose (Day 7) | 76.0 beats per minute | Standard Deviation 12.51 |
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | pre-dose (Day 1) | 78.0 beats per minute | Standard Deviation 13.02 |
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | immediately post-dose (Day 1) | 77.9 beats per minute | Standard Deviation 12.9 |
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | 15 minutes post-dose (Day 1) | 76.4 beats per minute | Standard Deviation 12.31 |
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | pre-dose (Day 7) | 77.8 beats per minute | Standard Deviation 12.31 |
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II) | immediately post-dose (Day 7) | 78.3 beats per minute | Standard Deviation 12.45 |
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
Time frame: Day 1, prior to first dose of iloprost PD-15
Population: safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-6 (Period I) | pre-dose | 79.2 beats per minute | Standard Deviation 13.14 |
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-6 (Period I) | immediately post-dose | 78.9 beats per minute | Standard Deviation 13.39 |
| Iloprost PD-6 | Heart Rate (HR) - Iloprost PD-6 (Period I) | 15 minutes post-dose | 76.1 beats per minute | Standard Deviation 13.25 |
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)
Time frame: 37 days following first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Number of Daily Inhalations - Iloprost PD-15 (Period II) | 6.0 inhalations/day | Standard Deviation 1.11 |
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)
Time frame: 37 days prior to first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Number of Daily Inhalations - Iloprost PD-6 (Period I) | 5.8 inhalations/day | Standard Deviation 1.22 |
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)
Time frame: 37 days following first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Percentage of Complete Doses Administered - Iloprost PD-15 (Period II) | 98.0 percentage of complete doses | Standard Deviation 3.42 |
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)
Time frame: 37 days prior to first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Percentage of Complete Doses Administered - Iloprost PD-6 (Period I) | 83.1 percentage of complete doses | Standard Deviation 21.18 |
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)
Time frame: 37 days following first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II) | 66.1 percentage of daily doses | Standard Deviation 21.2 |
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)
Time frame: 37 days prior to first dose of iloprost PD-15
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iloprost PD-6 | Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I) | 55.1 percentage of daily doses | Standard Deviation 29.53 |
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
Time frame: Day 1, prior to first dose of iloprost PD-15
Population: safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iloprost PD-6 | Systolic Blood Pressure - Iloprost PD-6 (Period I) | pre-dose | 114.1 mmHg | Standard Deviation 11.68 |
| Iloprost PD-6 | Systolic Blood Pressure - Iloprost PD-6 (Period I) | 15 minutes post dose | 113.0 mmHg | Standard Deviation 13.45 |
| Iloprost PD-6 | Systolic Blood Pressure - Iloprost PD-6 (Period I) | immediately post-dose | 110.8 mmHg | Standard Deviation 11.47 |
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
Time frame: Day 1 and Day 7, following the first dose of iloprost PD-15
Population: safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iloprost PD-6 | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | pre-dose (Day 1) | 114.5 mmHg | Standard Deviation 14.99 |
| Iloprost PD-6 | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | pre-dose (Day 7) | 114.7 mmHg | Standard Deviation 16.14 |
| Iloprost PD-6 | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | immediately post-dose (Day 7) | 109.7 mmHg | Standard Deviation 15.76 |
| Iloprost PD-6 | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | 15 minutes post-dose (Day 7) | 113.1 mmHg | Standard Deviation 15.39 |
| Iloprost PD-6 | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | immediately post-dose (Day 1) | 111.7 mmHg | Standard Deviation 14.39 |
| Iloprost PD-6 | Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II) | 15 minutes post-dose (Day 1) | 113.9 mmHg | Standard Deviation 14.76 |