Trial Outcomes & Findings for The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting (NCT NCT00467896)
NCT ID: NCT00467896
Last Updated: 2013-04-04
Results Overview
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)
TERMINATED
PHASE2
62 participants
37 days prior to first dose of iloprost PD-15
2013-04-04
Participant Flow
Patients were enrolled across 12 U.S. centers.
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
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Consent Withdrawal
|
18
|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Serious Adverse Event
|
13
|
|
Overall Study
Non-compliance
|
3
|
|
Overall Study
Changed therapy
|
2
|
|
Overall Study
Patient received transplant
|
2
|
|
Overall Study
Patient had atrial septostomy
|
1
|
|
Overall Study
Patient weaned off iloprost
|
1
|
|
Overall Study
Mainly used Prodose not I-neb® device
|
1
|
|
Overall Study
Started intravenous prostacyclin
|
1
|
|
Overall Study
Started inhaled Remodulin
|
1
|
|
Overall Study
Patient had no improvement
|
1
|
Baseline Characteristics
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
Baseline characteristics by cohort
| Measure |
Iloprost
n=62 Participants
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).
|
|---|---|
|
Age Continuous
|
52.5 years
STANDARD_DEVIATION 14.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 37 days prior to first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Inhalation-times Rate - Iloprost PD-6 (Period I)
|
29.9 percentage of full doses administered
Standard Deviation 28.75
|
PRIMARY outcome
Timeframe: 37 days following first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Inhalation-times Rate - Iloprost PD-15 (Period II)
|
79.7 percentage of full doses administered
Standard Deviation 17.45
|
PRIMARY outcome
Timeframe: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (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
|
SECONDARY outcome
Timeframe: 37 days prior to first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Number of Daily Inhalations - Iloprost PD-6 (Period I)
|
5.8 inhalations/day
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 37 days following first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Number of Daily Inhalations - Iloprost PD-15 (Period II)
|
6.0 inhalations/day
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: 37 days prior to first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Daily Inhalation Duration - Iloprost PD-6 (Period I)
|
15.0 minutes
Standard Deviation 5.48
|
SECONDARY outcome
Timeframe: 37 days following first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Daily Inhalation Duration - Iloprost PD-15 (Period II)
|
7.2 minutes
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: 37 days prior to first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)
|
83.1 percentage of complete doses
Standard Deviation 21.18
|
SECONDARY outcome
Timeframe: 37 days following first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)
|
98.0 percentage of complete doses
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: 37 days prior to first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (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 outcome
Timeframe: 37 days following first dose of iloprost PD-15Population: 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.
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)
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (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 outcome
Timeframe: Day 1, prior to first dose of iloprost PD-15Population: safety population
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
Outcome measures
| Measure |
Iloprost PD-6
n=62 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Systolic Blood Pressure - Iloprost PD-6 (Period I)
pre-dose
|
114.1 mmHg
Standard Deviation 11.68
|
|
Systolic Blood Pressure - Iloprost PD-6 (Period I)
immediately post-dose
|
110.8 mmHg
Standard Deviation 11.47
|
|
Systolic Blood Pressure - Iloprost PD-6 (Period I)
15 minutes post dose
|
113.0 mmHg
Standard Deviation 13.45
|
SECONDARY outcome
Timeframe: Day 1 and Day 7, following the first dose of iloprost PD-15Population: safety population
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
Outcome measures
| Measure |
Iloprost PD-6
n=62 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Day 1, prior to first dose of iloprost PD-15Population: safety population
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
Outcome measures
| Measure |
Iloprost PD-6
n=62 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
pre-dose
|
68.6 mmHg
Standard Deviation 10.94
|
|
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
immediately post-dose
|
65.6 mmHg
Standard Deviation 8.98
|
|
Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
15 minutes post-dose
|
66.6 mmHg
Standard Deviation 9.79
|
SECONDARY outcome
Timeframe: Day 1 and Day 7, following the first dose of iloprost PD-15Population: safety population
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
Outcome measures
| Measure |
Iloprost PD-6
n=45 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Day 1, prior to first dose of iloprost PD-15Population: safety population
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
Outcome measures
| Measure |
Iloprost PD-6
n=62 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
|
|---|---|
|
Heart Rate (HR) - Iloprost PD-6 (Period I)
pre-dose
|
79.2 beats per minute
Standard Deviation 13.14
|
|
Heart Rate (HR) - Iloprost PD-6 (Period I)
immediately post-dose
|
78.9 beats per minute
Standard Deviation 13.39
|
|
Heart Rate (HR) - Iloprost PD-6 (Period I)
15 minutes post-dose
|
76.1 beats per minute
Standard Deviation 13.25
|
SECONDARY outcome
Timeframe: Day 1 and Day 7, following the first dose of iloprost PD-15Population: safety population
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
Outcome measures
| Measure |
Iloprost PD-6
n=62 Participants
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (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
|
|
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
|
|
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 12.90
|
|
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
|
|
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
|
|
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
|
Adverse Events
Iloprost PD-15
Serious adverse events
| Measure |
Iloprost PD-15
n=62 participants at risk
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
|
16.1%
10/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
4.8%
3/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Right Ventricular Failure
|
4.8%
3/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Cardiac Failure
|
3.2%
2/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Acute Right Ventricular Failure
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Atrial Tachycardia
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Coronary Artery Disease
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Coronary Artery Occlusion
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Bronchitis
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Diverticulitis
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Pneumonia Bacterial
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Sepsis
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Urosepsis
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Reflux Oesophagitis
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Nervous system disorders
Syncope
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
2/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Blood and lymphatic system disorders
Heparin-Induced Thrombocytopenia
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Metabolism and nutrition disorders
Fluid Overload
|
3.2%
2/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Renal and urinary disorders
Renal Failure
|
3.2%
2/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Hepatobiliary disorders
Hepatitis
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Investigations
Liver Function Test Abnormal
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
1.6%
1/62 • Adverse events were collected from baseline visit to end of study visit
|
Other adverse events
| Measure |
Iloprost PD-15
n=62 participants at risk
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Arterial Hypertension
|
29.0%
18/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
21.0%
13/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.5%
9/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
14.5%
9/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.1%
5/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Nervous system disorders
Headache
|
11.3%
7/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Nervous system disorders
Syncope
|
9.7%
6/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Sinusitis
|
12.9%
8/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
11.3%
7/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Infections and infestations
Urinary Tract Infection
|
8.1%
5/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Nausea
|
17.7%
11/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
7/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
6/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Gastrointestinal disorders
Constipation
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
|
General disorders
Fatigue
|
21.0%
13/62 • Adverse events were collected from baseline visit to end of study visit
|
|
General disorders
Chest Pain
|
11.3%
7/62 • Adverse events were collected from baseline visit to end of study visit
|
|
General disorders
Oedema
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.5%
9/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Metabolism and nutrition disorders
Fluid Retention
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
9.7%
6/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.7%
6/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.1%
5/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Cardiac disorders
Palpitations
|
9.7%
6/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Investigations
International Normalised Ratio Increased
|
8.1%
5/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Vascular disorders
Flushing
|
8.1%
5/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Psychiatric disorders
Anxiety
|
9.7%
6/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Psychiatric disorders
Depression
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Psychiatric disorders
Insomnia
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Blood and lymphatic system disorders
Anaemia
|
8.1%
5/62 • Adverse events were collected from baseline visit to end of study visit
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
4/62 • Adverse events were collected from baseline visit to end of study visit
|
Additional Information
Wade Benton, Pharm D / Director, Medical Affairs Veletri and Ventavis
Actelion Pharmaceuticals, US, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place