Trial Outcomes & Findings for Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (NCT NCT00709098)
NCT ID: NCT00709098
Last Updated: 2015-09-28
Results Overview
Number of adverse events
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
49 participants
Primary outcome timeframe
Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.
Results posted on
2015-09-28
Participant Flow
The double-blind period of the study was conducted at 20 centers in the US and Germany, and the following open-label period of the study was conducted at 17 centers in the US only. First patient, first visit was 4 September 2008 and the last patient, last visit was 17 June 2010.
Out of the 63 patients who completed the core study of AC-063A301, 49 gave informed consent and enrolled into this extension study.
Participant milestones
| Measure |
Iloprost Power 6 (Double-blind Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Double-blind Period
STARTED
|
25
|
24
|
0
|
|
Double-blind Period
COMPLETED
|
19
|
16
|
0
|
|
Double-blind Period
NOT COMPLETED
|
6
|
8
|
0
|
|
Open-label Period
STARTED
|
0
|
0
|
32
|
|
Open-label Period
COMPLETED
|
0
|
0
|
18
|
|
Open-label Period
NOT COMPLETED
|
0
|
0
|
14
|
Reasons for withdrawal
| Measure |
Iloprost Power 6 (Double-blind Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Double-blind Period
Withdrawal of consent
|
3
|
3
|
0
|
|
Double-blind Period
Administrative reason
|
1
|
3
|
0
|
|
Double-blind Period
Death
|
1
|
1
|
0
|
|
Double-blind Period
Lost to Follow-up
|
1
|
1
|
0
|
|
Open-label Period
Withdrawal of consent
|
0
|
0
|
7
|
|
Open-label Period
Administrative reason
|
0
|
0
|
5
|
|
Open-label Period
Death
|
0
|
0
|
1
|
|
Open-label Period
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
FULL_RANGE 16.49 • n=5 Participants
|
55.4 years
FULL_RANGE 13.96 • n=7 Participants
|
—
|
56.9 years
FULL_RANGE 15.21 • n=4 Participants
|
|
Gender
Female
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
—
|
38 participants
n=4 Participants
|
|
Gender
Male
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
—
|
11 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
22 participants
n=7 Participants
|
—
|
45 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
—
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.Population: Safety population
Number of adverse events
Outcome measures
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
n=32 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Treatment-emergent Adverse Events
|
148 adverse events
|
139 adverse events
|
126 adverse events
|
PRIMARY outcome
Timeframe: Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication, mean duration of exposure was 284.5 days.Population: Safety population
Number of serious adverse events
Outcome measures
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
n=32 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Treatment-emergent Serious Adverse Events
|
11 serious adverse events
|
11 serious adverse events
|
10 serious adverse events
|
PRIMARY outcome
Timeframe: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.Population: Safety population
Number of adverse events leading to discontinuation of study treatment
Outcome measures
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
n=32 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Adverse Events Leading to Premature Discontinuation of Study Drug
|
3 adverse events
|
10 adverse events
|
7 adverse events
|
PRIMARY outcome
Timeframe: Double-blind period: from the first inhalation of study drug to discontinuation. Open-label period: from the start of open-label medication to discontinuation, mean duration of exposure was 284.5 days.Number of patients with adverse events leading to discontinuation of study treatment
Outcome measures
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
n=32 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Patients With Adverse Events Leading to Premature Discontinuation of Study Drug
|
2 participants
|
6 participants
|
7 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: All treated population
Average inhalation time of iloprost during the double-blind period (i.e., the sum of the duration of each inhalation divided by the number of inhalations during the double-blind period)
Outcome measures
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 Participants
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Average Inhalation Time
|
10.9 minutes
Standard Deviation 4.50
|
5.8 minutes
Standard Deviation 1.14
|
—
|
Adverse Events
Iloprost Power 6 (Double-blind Period)
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Iloprost Power 15 (Double-blind Period)
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Iloprost Power 15 (Open-label Period)
Serious events: 8 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 participants at risk
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 participants at risk
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
n=32 participants at risk
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
BRONCHITIS
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
3.1%
1/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
DIVERTICULITIS
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
DIVERTICULUM
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
3.1%
1/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
LOBAR PNEUMONIA
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
3.1%
1/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
SEPSIS
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
General disorders
SUDDEN CARDIAC DEATH
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Nervous system disorders
SYNCOPE
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
3.1%
1/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERIAL HYPERTENSION
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
9.4%
3/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
3.1%
1/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
General disorders
NO THERAPEUTIC RESPONSE
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
3.1%
1/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
3.1%
1/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
Other adverse events
| Measure |
Iloprost Power 6 (Double-blind Period)
n=25 participants at risk
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb® adaptive aerosol delivery (AAD®) System utilizing a power setting 6 disc
|
Iloprost Power 15 (Double-blind Period)
n=24 participants at risk
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
Iloprost Power 15 (Open-label Period)
n=32 participants at risk
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
|
|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
44.0%
11/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
54.2%
13/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
28.0%
7/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
41.7%
10/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Nervous system disorders
DIZZINESS
|
32.0%
8/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
29.2%
7/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
12.5%
4/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Vascular disorders
FLUSHING
|
24.0%
6/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
33.3%
8/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
NAUSEA
|
24.0%
6/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
20.8%
5/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
15.6%
5/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
General disorders
CHEST DISCOMFORT
|
24.0%
6/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
16.7%
4/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
20.0%
5/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
12.5%
3/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
15.6%
5/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
DIARRHOEA
|
12.0%
3/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
16.7%
4/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
15.6%
5/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
12.0%
3/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
16.7%
4/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
9.4%
3/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
General disorders
CHEST PAIN
|
8.0%
2/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
16.7%
4/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
General disorders
FATIGUE
|
4.0%
1/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
16.7%
4/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
12.0%
3/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
8.3%
2/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.0%
2/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
8.3%
2/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Psychiatric disorders
DEPRESSION
|
8.0%
2/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
8.3%
2/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
8.0%
2/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
8.3%
2/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
VOMITING
|
16.0%
4/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
9.4%
3/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
General disorders
ASTHENIA
|
8.0%
2/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
NASOPHARYNGITIS
|
8.0%
2/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
4.2%
1/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
12.5%
3/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
9.4%
3/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
9.4%
3/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
9.4%
3/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/25 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
0.00%
0/24 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
6.2%
2/32 • Double-blind period: from first inhalation of study drug to end of 12-week treatment period. Open-label period: from the start to end of open-label medication
Treatment-emergent adverse events
|
Additional Information
Laila Rouault, MD/International Clinical Leader
Actelion Pharmaceuticals Ltd
Phone: + 41 61 565 8128
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place