Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 61 for:    "Lung Disease" | "Iloprost"

The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00467896
Recruitment Status : Terminated (Sponsor's decision)
First Posted : May 1, 2007
Results First Posted : October 26, 2012
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Hypertension
Interventions Drug: Iloprost PD-6
Drug: Iloprost PD-15
Enrollment 62
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
Arm/Group Title Iloprost
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 62
Completed 11
Not Completed 51
Reason Not Completed
Consent Withdrawal             18
Adverse Event             7
Serious Adverse Event             13
Non-compliance             3
Changed therapy             2
Patient received transplant             2
Patient had atrial septostomy             1
Patient weaned off iloprost             1
Mainly used Prodose not I-neb® device             1
Started intravenous prostacyclin             1
Started inhaled Remodulin             1
Patient had no improvement             1
Arm/Group Title Iloprost
Hide Arm/Group Description 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 Number of Baseline Participants 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
<=18 years
1
   1.6%
Between 18 and 65 years
43
  69.4%
>=65 years
18
  29.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
52.5  (14.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
46
  74.2%
Male
16
  25.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants
62
1.Primary Outcome
Title Inhalation-times Rate - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of full doses administered
29.9  (28.75)
2.Primary Outcome
Title Inhalation-times Rate - Iloprost PD-15 (Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of full doses administered
79.7  (17.45)
3.Primary Outcome
Title Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) in Period I and Power Disc-15 (PD-15)in Period II.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of full doses administered
49.8  (34.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iloprost PD-15
Comments Comparison of the change in inhalation-times rate from Period I (PD-6) to Period II (PD-15)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 49.8
Confidence Interval (2-Sided) 95%
39.55 to 60.15
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Daily Inhalations - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: inhalations/day
5.8  (1.22)
5.Secondary Outcome
Title Number of Daily Inhalations - Iloprost PD-15 (Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: inhalations/day
6.0  (1.11)
6.Secondary Outcome
Title Daily Inhalation Duration - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: minutes
15.0  (5.48)
7.Secondary Outcome
Title Daily Inhalation Duration - Iloprost PD-15 (Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: minutes
7.2  (2.17)
8.Secondary Outcome
Title Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of complete doses
83.1  (21.18)
9.Secondary Outcome
Title Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of complete doses
98.0  (3.42)
10.Secondary Outcome
Title Percentage of Daily Doses Within the 6–9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of daily doses
55.1  (29.53)
11.Secondary Outcome
Title Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percentage of daily doses
66.1  (21.2)
12.Secondary Outcome
Title Systolic Blood Pressure - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: mmHg
pre-dose 114.1  (11.68)
immediately post-dose 110.8  (11.47)
15 minutes post dose 113.0  (13.45)
13.Secondary Outcome
Title Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: mmHg
pre-dose (Day 1) 114.5  (14.99)
immediately post-dose (Day 1) 111.7  (14.39)
15 minutes post-dose (Day 1) 113.9  (14.76)
pre-dose (Day 7) 114.7  (16.14)
immediately post-dose (Day 7) 109.7  (15.76)
15 minutes post-dose (Day 7) 113.1  (15.39)
14.Secondary Outcome
Title Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: mmHg
pre-dose 68.6  (10.94)
immediately post-dose 65.6  (8.98)
15 minutes post-dose 66.6  (9.79)
15.Secondary Outcome
Title Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: mmHg
pre-dose (Day 1) 67.5  (10.44)
immediately post-dose (Day 1) 65.2  (8.72)
15 minutes post-dose (Day 1) 67.9  (11.16)
pre-dose (Day 7) 68.6  (11.22)
immediately post-dose (Day 7) 65.7  (11.34)
15 minutes post-dose (Day 7) 66.7  (11.52)
16.Secondary Outcome
Title Heart Rate (HR) - Iloprost PD-6 (Period I)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Iloprost PD-6
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: beats per minute
pre-dose 79.2  (13.14)
immediately post-dose 78.9  (13.39)
15 minutes post-dose 76.1  (13.25)
17.Secondary Outcome
Title Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
safety population
Arm/Group Title Iloprost PD-15
Hide Arm/Group Description:
iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: beats per minute
pre-dose (Day 1) 78.0  (13.02)
immediately post-dose (Day 1) 77.9  (12.90)
15 minutes post-dose (Day 1) 76.4  (12.31)
pre-dose (Day 7) 77.8  (12.31)
immediately post-dose (Day 7) 78.3  (12.45)
15 minutes post-dose (Day 7) 76.0  (12.51)
Time Frame Adverse events were collected from baseline visit to end of study visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iloprost PD-15
Hide Arm/Group Description iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
All-Cause Mortality
Iloprost PD-15
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Iloprost PD-15
Affected / at Risk (%)
Total   27/62 (43.55%) 
Blood and lymphatic system disorders   
Anaemia  1  2/62 (3.23%) 
Heparin-Induced Thrombocytopenia  1  1/62 (1.61%) 
Cardiac disorders   
Right Ventricular Failure  1  3/62 (4.84%) 
Cardiac Failure  1  2/62 (3.23%) 
Acute Coronary Syndrome  1  1/62 (1.61%) 
Acute Myocardial Infarction  1  1/62 (1.61%) 
Acute Right Ventricular Failure  1  1/62 (1.61%) 
Atrial Tachycardia  1  1/62 (1.61%) 
Cardiac Failure Congestive  1  1/62 (1.61%) 
Coronary Artery Disease  1  1/62 (1.61%) 
Coronary Artery Occlusion  1  1/62 (1.61%) 
Gastrointestinal disorders   
Gastrointestinal Haemorrhage  1  1/62 (1.61%) 
Nausea  1  1/62 (1.61%) 
Pancreatitis Acute  1  1/62 (1.61%) 
Reflux Oesophagitis  1  1/62 (1.61%) 
Vomiting  1  1/62 (1.61%) 
Hepatobiliary disorders   
Hepatitis  1  1/62 (1.61%) 
Infections and infestations   
Bronchitis  1  1/62 (1.61%) 
Diverticulitis  1  1/62 (1.61%) 
Pneumonia  1  1/62 (1.61%) 
Pneumonia Bacterial  1  1/62 (1.61%) 
Sepsis  1  1/62 (1.61%) 
Urosepsis  1  1/62 (1.61%) 
Injury, poisoning and procedural complications   
Therapeutic Agent Toxicity  1  1/62 (1.61%) 
Investigations   
Liver Function Test Abnormal  1  1/62 (1.61%) 
Metabolism and nutrition disorders   
Fluid Overload  1  2/62 (3.23%) 
Hyperkalaemia  1  1/62 (1.61%) 
Hypoglycaemia  1  1/62 (1.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon Cancer  1  1/62 (1.61%) 
Meningioma  1  1/62 (1.61%) 
Pancreatic Neoplasm  1  1/62 (1.61%) 
Renal Cell Carcinoma  1  1/62 (1.61%) 
Uterine Leiomyoma  1  1/62 (1.61%) 
Nervous system disorders   
Syncope  1  4/62 (6.45%) 
Renal and urinary disorders   
Renal Failure  1  2/62 (3.23%) 
Reproductive system and breast disorders   
Vaginal Haemorrhage  1  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Arterial Hypertension  1  10/62 (16.13%) 
Pulmonary Hypertension  1  3/62 (4.84%) 
Acute Respiratory Failure  1  1/62 (1.61%) 
Dyspnoea  1  1/62 (1.61%) 
Pulmonary Embolism  1  1/62 (1.61%) 
Respiratory Arrest  1  1/62 (1.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Iloprost PD-15
Affected / at Risk (%)
Total   53/62 (85.48%) 
Blood and lymphatic system disorders   
Anaemia  1  5/62 (8.06%) 
Cardiac disorders   
Palpitations  1  6/62 (9.68%) 
Gastrointestinal disorders   
Nausea  1  11/62 (17.74%) 
Diarrhoea  1  7/62 (11.29%) 
Vomiting  1  6/62 (9.68%) 
Constipation  1  4/62 (6.45%) 
General disorders   
Fatigue  1  13/62 (20.97%) 
Chest Pain  1  7/62 (11.29%) 
Oedema  1  4/62 (6.45%) 
Infections and infestations   
Sinusitis  1  8/62 (12.90%) 
Upper Respiratory Tract Infection  1  7/62 (11.29%) 
Urinary Tract Infection  1  5/62 (8.06%) 
Investigations   
International Normalised Ratio Increased  1  5/62 (8.06%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  9/62 (14.52%) 
Fluid Retention  1  4/62 (6.45%) 
Musculoskeletal and connective tissue disorders   
Muscle Spasms  1  6/62 (9.68%) 
Pain In Extremity  1  6/62 (9.68%) 
Back Pain  1  5/62 (8.06%) 
Arthralgia  1  4/62 (6.45%) 
Nervous system disorders   
Headache  1  7/62 (11.29%) 
Syncope  1  6/62 (9.68%) 
Psychiatric disorders   
Anxiety  1  6/62 (9.68%) 
Depression  1  4/62 (6.45%) 
Insomnia  1  4/62 (6.45%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary Arterial Hypertension  1  18/62 (29.03%) 
Dyspnoea  1  13/62 (20.97%) 
Cough  1  9/62 (14.52%) 
Pulmonary Hypertension  1  9/62 (14.52%) 
Epistaxis  1  5/62 (8.06%) 
Skin and subcutaneous tissue disorders   
Rash  1  4/62 (6.45%) 
Vascular disorders   
Flushing  1  5/62 (8.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Study was terminated early due to the discontinuation of the I-neb Power Disc-15 development program.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wade Benton, Pharm D / Director, Medical Affairs Veletri and Ventavis
Organization: Actelion Pharmaceuticals, US, Inc.
Phone: (650) 624-6900
EMail: wade.benton@actelion.com
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00467896     History of Changes
Other Study ID Numbers: C200-008
First Submitted: April 27, 2007
First Posted: May 1, 2007
Results First Submitted: September 27, 2012
Results First Posted: October 26, 2012
Last Update Posted: April 4, 2013