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Trial record 32 of 61 for:    "Lung Disease" | "Iloprost"

Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15 Ext)

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: NCT00709098
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : October 29, 2012
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Intervention Drug: iloprost
Enrollment 49
Recruitment Details 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.
Pre-assignment Details Out of the 63 patients who completed the core study of AC-063A301, 49 gave informed consent and enrolled into this extension study.
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Hide Arm/Group Description 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 The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Period Title: Double-blind Period
Started 25 24 0
Completed 19 16 0
Not Completed 6 8 0
Reason Not Completed
Withdrawal of consent             3             3             0
Administrative reason             1             3             0
Death             1             1             0
Lost to Follow-up             1             1             0
Period Title: Open-label Period
Started 0 0 32 [1]
Completed 0 0 18
Not Completed 0 0 14
Reason Not Completed
Withdrawal of consent             0             0             7
Administrative reason             0             0             5
Death             0             0             1
Lost to Follow-up             0             0             1
[1]
The open-label period was only made available to patients in US centers
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period) Total
Hide Arm/Group Description 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 The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc Total of all reporting groups
Overall Number of Baseline Participants 25 24 0 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants 24 participants 0 participants 49 participants
58.3
(25 to 87)
55.4
(29 to 79)
56.9
(25 to 87)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 0 participants 49 participants
Female 19 19 38
Male 6 5 11
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 24 participants 0 participants 49 participants
United States 23 22 45
Germany 2 2 4
1.Primary Outcome
Title Treatment-emergent Adverse Events
Hide Description Number of adverse events
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Hide Arm/Group Description:
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
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Overall Number of Participants Analyzed 25 24 32
Measure Type: Number
Unit of Measure: adverse events
148 139 126
2.Primary Outcome
Title Treatment-emergent Serious Adverse Events
Hide Description Number of serious adverse events
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Hide Arm/Group Description:
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
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Overall Number of Participants Analyzed 25 24 32
Measure Type: Number
Unit of Measure: serious adverse events
11 11 10
3.Primary Outcome
Title Adverse Events Leading to Premature Discontinuation of Study Drug
Hide Description Number of adverse events leading to discontinuation of study treatment
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Hide Arm/Group Description:
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
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Overall Number of Participants Analyzed 25 24 32
Measure Type: Number
Unit of Measure: adverse events
3 10 7
4.Primary Outcome
Title Patients With Adverse Events Leading to Premature Discontinuation of Study Drug
Hide Description Number of patients with adverse events leading to discontinuation of study treatment
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Hide Arm/Group Description:
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
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Overall Number of Participants Analyzed 25 24 32
Measure Type: Number
Unit of Measure: participants
2 6 7
5.Other Pre-specified Outcome
Title Average Inhalation Time
Hide Description 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)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated population
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period)
Hide Arm/Group Description:
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 6 disc
The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
Overall Number of Participants Analyzed 25 24
Mean (Standard Deviation)
Unit of Measure: minutes
10.9  (4.50) 5.8  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iloprost Power 6 (Double-blind Period), Iloprost Power 15 (Double-blind Period)
Comments [Not Specified]
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 group difference
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-7.0 to -3.1
Estimation Comments [Not Specified]
Time Frame 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
Adverse Event Reporting Description Treatment-emergent adverse events
 
Arm/Group Title Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Hide Arm/Group Description 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 The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc The study medication was 5 μg iloprost delivered as an aerosol using the I-neb®AAD® System utilizing a power setting 15 disc
All-Cause Mortality
Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Iloprost Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/25 (24.00%)   5/24 (20.83%)   8/32 (25.00%) 
Cardiac disorders       
ATRIAL FIBRILLATION  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
ATRIAL FLUTTER  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
RIGHT VENTRICULAR FAILURE  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
Gastrointestinal disorders       
COLITIS  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
DIVERTICULUM  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
General disorders       
SUDDEN CARDIAC DEATH  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
NO THERAPEUTIC RESPONSE  1  0/25 (0.00%)  0/24 (0.00%)  1/32 (3.13%) 
Hepatobiliary disorders       
CHOLECYSTITIS ACUTE  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
Infections and infestations       
BRONCHITIS  1  1/25 (4.00%)  0/24 (0.00%)  1/32 (3.13%) 
DIVERTICULITIS  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
LOBAR PNEUMONIA  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
SEPSIS  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
URINARY TRACT INFECTION  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
PNEUMONIA  1  0/25 (0.00%)  0/24 (0.00%)  1/32 (3.13%) 
Investigations       
LIVER FUNCTION TEST ABNORMAL  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
PROSTATE CANCER  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
Nervous system disorders       
CEREBROVASCULAR ACCIDENT  1  1/25 (4.00%)  0/24 (0.00%)  0/32 (0.00%) 
SYNCOPE  1  1/25 (4.00%)  0/24 (0.00%)  1/32 (3.13%) 
Renal and urinary disorders       
RENAL FAILURE ACUTE  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
HYPOXIA  1  0/25 (0.00%)  1/24 (4.17%)  1/32 (3.13%) 
PULMONARY HYPERTENSION  1  1/25 (4.00%)  0/24 (0.00%)  1/32 (3.13%) 
RESPIRATORY FAILURE  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
PULMONARY ARTERIAL HYPERTENSION  1  0/25 (0.00%)  0/24 (0.00%)  3/32 (9.38%) 
DYSPNOEA  1  0/25 (0.00%)  0/24 (0.00%)  1/32 (3.13%) 
Vascular disorders       
PERIPHERAL VASCULAR DISORDER  1  0/25 (0.00%)  1/24 (4.17%)  0/32 (0.00%) 
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 Power 6 (Double-blind Period) Iloprost Power 15 (Double-blind Period) Iloprost Power 15 (Open-label Period)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/25 (92.00%)   23/24 (95.83%)   25/32 (78.13%) 
Cardiac disorders       
PALPITATIONS  1  0/25 (0.00%)  0/24 (0.00%)  3/32 (9.38%) 
Gastrointestinal disorders       
NAUSEA  1  6/25 (24.00%)  5/24 (20.83%)  5/32 (15.63%) 
DIARRHOEA  1  3/25 (12.00%)  4/24 (16.67%)  5/32 (15.63%) 
ABDOMINAL PAIN  1  2/25 (8.00%)  2/24 (8.33%)  0/32 (0.00%) 
VOMITING  1  4/25 (16.00%)  0/24 (0.00%)  3/32 (9.38%) 
ABDOMINAL PAIN UPPER  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
General disorders       
CHEST DISCOMFORT  1  6/25 (24.00%)  4/24 (16.67%)  0/32 (0.00%) 
CHEST PAIN  1  2/25 (8.00%)  4/24 (16.67%)  2/32 (6.25%) 
FATIGUE  1  1/25 (4.00%)  4/24 (16.67%)  2/32 (6.25%) 
ASTHENIA  1  2/25 (8.00%)  1/24 (4.17%)  0/32 (0.00%) 
OEDEMA PERIPHERAL  1  0/25 (0.00%)  0/24 (0.00%)  3/32 (9.38%) 
Infections and infestations       
UPPER RESPIRATORY TRACT INFECTION  1  5/25 (20.00%)  3/24 (12.50%)  5/32 (15.63%) 
NASOPHARYNGITIS  1  2/25 (8.00%)  1/24 (4.17%)  0/32 (0.00%) 
ACUTE SINUSITIS  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
BRONCHITIS  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
EAR INFECTION  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
INFLUENZA  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
SINUSITIS  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
URINARY TRACT INFECTION  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
Musculoskeletal and connective tissue disorders       
PAIN IN JAW  1  3/25 (12.00%)  2/24 (8.33%)  2/32 (6.25%) 
BACK PAIN  1  0/25 (0.00%)  0/24 (0.00%)  3/32 (9.38%) 
Nervous system disorders       
HEADACHE  1  11/25 (44.00%)  13/24 (54.17%)  2/32 (6.25%) 
DIZZINESS  1  8/25 (32.00%)  7/24 (29.17%)  4/32 (12.50%) 
SYNCOPE  1  0/25 (0.00%)  3/24 (12.50%)  0/32 (0.00%) 
Psychiatric disorders       
DEPRESSION  1  2/25 (8.00%)  2/24 (8.33%)  0/32 (0.00%) 
ANXIETY  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
INSOMNIA  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  7/25 (28.00%)  10/24 (41.67%)  2/32 (6.25%) 
DYSPNOEA  1  3/25 (12.00%)  4/24 (16.67%)  3/32 (9.38%) 
OROPHARYNGEAL PAIN  1  2/25 (8.00%)  2/24 (8.33%)  0/32 (0.00%) 
DYSPNOEA EXERTIONAL  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
HYPOXIA  1  0/25 (0.00%)  0/24 (0.00%)  2/32 (6.25%) 
Vascular disorders       
FLUSHING  1  6/25 (24.00%)  8/24 (33.33%)  0/32 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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: Laila Rouault, MD/International Clinical Leader
Organization: Actelion Pharmaceuticals Ltd
Phone: + 41 61 565 8128
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00709098     History of Changes
Other Study ID Numbers: AC-063A302
First Submitted: July 1, 2008
First Posted: July 3, 2008
Results First Submitted: September 27, 2012
Results First Posted: October 29, 2012
Last Update Posted: September 28, 2015