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Trial record 34 of 61 for:    "Lung Disease" | "Iloprost"

Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15)

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ClinicalTrials.gov Identifier: NCT00709956
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : October 26, 2012
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Actelion

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pulmonary Arterial Hypertension
Interventions Drug: iloprost (5 µg)
Drug: placebo
Enrollment 64
Recruitment Details On Day 1 all patients received a single inhalation dose of placebo. Patients who satisfied the selection criteria in the single-blind period of the study were entered into the double-blind period to receive iloprost 5 μg and matching placebo (Days 2 and 3) in a single dose, two-period crossover design.
Pre-assignment Details Of the 70 randomized patients, 64 patients entered the double-blind period, (placebo/iloprost P15, 33 patients and iloprost P15/placebo, 31 patients). 1 patient in the iloprost P15/placebo treatment sequence was excluded from the per-protocol analysis which was defined as the primary analysis.
Arm/Group Title Iloprost (5µg) / Placebo Placebo / Iloprost (5 µg)
Hide Arm/Group Description Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3 Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
Period Title: Overall Study
Started 33 [1] 37 [1]
Double-blind Crossover-period 31 [2] 33 [2]
Completed 30 33
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             1             1
Inclusion/exclusion criteria violation             2             3
[1]
Day 1 Single-blind placebo run-in
[2]
Days 2 and 3
Arm/Group Title Iloprost (5µg) / Placebo Placebo / Iloprost (5 µg) Total
Hide Arm/Group Description Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3 Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3 Total of all reporting groups
Overall Number of Baseline Participants 31 33 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
  71.0%
24
  72.7%
46
  71.9%
>=65 years
9
  29.0%
9
  27.3%
18
  28.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 33 participants 64 participants
55.5  (13.57) 55.8  (16.40) 55.7  (14.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Female
23
  74.2%
28
  84.8%
51
  79.7%
Male
8
  25.8%
5
  15.2%
13
  20.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
United States 28 30 58
Austria 2 2 4
Germany 1 1 2
1.Primary Outcome
Title 6-minute-walk Distance (6MWD)
Hide Description

The 6-minute walk test was performed 20-40 minutes after treatment. This was a non-encouraged test (the person conducting the test did not encourage the patient to walk farther or faster) that measured the distance covered over a 6-minute walk.

It was conducted by a trained member of the site staff who was listed on the site’s delegation of authority sheet. For patients who had never performed a 6-minute walk test previously, a training test was requested before the qualifying tests for randomization.

Time Frame Study day 2 or study day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.
Arm/Group Title 6MWD After Placebo Treatment 6MWD After Iloprost (5 µg) Treatment
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 63 63
Least Squares Mean (95% Confidence Interval)
Unit of Measure: meters
330.0
(322.3 to 337.7)
328.6
(320.9 to 336.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 6MWD After Placebo Treatment, 6MWD After Iloprost (5 µg) Treatment
Comments With a sample size of at least 63 patients and based on the assumptions on the primary endpoint (normal distribution, SD of the difference of 30 m) the study was designed to detect a significant treatment effect with 90% power, assuming a difference exceeding 12.5 m between the mean values of the 6MWD following the iloprost power 15 treatment and the one following the placebo treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7883
Comments If the primary endpoint reaches significance, treatment effect of the secondary endpoint is determined at a 2-sided nominal of 0.05. Since hierarchy of the endpoints to be tested has been predefined, no correction for multiple testing will be applied
Method Generalized linear model
Comments Subject (sequence), treatment, and period as fixed effect
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-12.3 to 9.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Borg Dyspnea Score
Hide Description The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labeled "extremely severe," or "the worst possible dyspnea imaginable." Reliability and validity have been reported in a general population and in patients with PAH as well as other respiratory conditions.
Time Frame Study day 2 or study day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was per protocol, 64 patients started double blind phase of study, 63 completed.
Arm/Group Title Borg Dyspnea Score After Placebo Treatment Borg Dyspnea Score After Iloprost (5 µg) Treatment
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 63 63
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.5  (2.23) 3.4  (2.25)
Time Frame [Not Specified]
Adverse Event Reporting Description Due to data capture design constraints the time of adverse event (AE) onset was not collected, therefore the potential to assign potential causality to active treatment or placebo was not assessed. AE's can only be reported as shown, as prospectively planned in the protocol submitted to FDA. Includes all patients entered in the double-blind phase.
 
Arm/Group Title Iloprost (5µg) / Placebo Placebo / Iloprost (5 µg)
Hide Arm/Group Description Single dose double-blind active iloprost (5µg) on study day 2 followed by single dose double-blind placebo on study day 3 Single dose double-blind placebo on study day 2 followed by single dose double-blind active iloprost (5µg) on study day 3
All-Cause Mortality
Iloprost (5µg) / Placebo Placebo / Iloprost (5 µg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Iloprost (5µg) / Placebo Placebo / Iloprost (5 µg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      1/33 (3.03%)    
Cardiac disorders     
Right ventricular failure  1  0/31 (0.00%)  0 1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary arterial hypertension  1  0/31 (0.00%)  0 1/33 (3.03%)  1
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 (5µg) / Placebo Placebo / Iloprost (5 µg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/31 (51.61%)      20/33 (60.61%)    
Gastrointestinal disorders     
Diarrhoea  1  0/31 (0.00%)  2/33 (6.06%) 
Nausea  1  0/31 (0.00%)  2/33 (6.06%) 
General disorders     
Pyrexia  1  0/31 (0.00%)  2/33 (6.06%) 
Musculoskeletal and connective tissue disorders     
Muscle tightness  1  0/31 (0.00%)  2/33 (6.06%) 
Pain in extremity  1  2/31 (6.45%)  0/33 (0.00%) 
Nervous system disorders     
Dizziness  1  2/31 (6.45%)  4/33 (12.12%) 
Headache  1  3/31 (9.68%)  3/33 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/31 (12.90%)  4/33 (12.12%) 
Dysphonia  1  2/31 (6.45%)  0/33 (0.00%) 
Dyspnoea  1  1/31 (3.23%)  3/33 (9.09%) 
Oropharyngeal pain  1  1/31 (3.23%)  3/33 (9.09%) 
Rhinorrhoea  1  0/31 (0.00%)  3/33 (9.09%) 
Throat irritation  1  5/31 (16.13%)  1/33 (3.03%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/31 (0.00%)  2/33 (6.06%) 
Vascular disorders     
Flushing  1  4/31 (12.90%)  5/33 (15.15%) 
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, M.D.
Organization: Actelion
Phone: + 41 61 565 8128
EMail: laila.rouault@actelion.com
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00709956     History of Changes
Other Study ID Numbers: AC-063A301
First Submitted: July 1, 2008
First Posted: July 3, 2008
Results First Submitted: October 7, 2010
Results First Posted: October 26, 2012
Last Update Posted: September 28, 2015