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Iloprost Power 15 in Pulmonary Arterial Hypertension (PROWESS 15)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
iloprost (5 µg)
placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Ventavis, iloprost, inhaled treatment, pulmonary arterial hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent prior to initiation of any study mandated procedure,
  • Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (HIV) or drugs/toxins in NYHA functional class II to IV.
  • Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.

Exclusion Criteria:

  • Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
  • Pulmonary arterial hypertension associated with significant venous or capillary involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg),
  • Known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
  • Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration,
  • Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,
  • Pregnant or breast-feeding women,
  • Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),
  • Systolic blood pressure < 95 mmHg,
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
  • Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
  • Clinically relevant bleeding disorder or active bleeding,
  • For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,
  • Known hypersensitivity to iloprost or any of its excipients.

Sites / Locations

  • UCSD Medical Center
  • UC Davis Medical Center
  • Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
  • Lung Health & Sleep Enhancement Center, LLC
  • University of Florida
  • Pulmonary & Critical Care of Atlanta
  • Atlanta Institute for Medical Research
  • University of Iowa Hospitals and Clinics
  • Mercy Hospital
  • Kentuckiana Pulmonary Associates
  • LSU Health Sciences Center
  • University of Maryland Medical Center
  • University of Nebraska Medical Center
  • Newark Beth Israel Medical Center
  • Winthrop University Hospital
  • University of North Carolina
  • The Lindner Clinical Trial Center
  • The Ohio State University Medical Center
  • Legacy Health System
  • Temple University Hospital
  • Allegheny General Hospital
  • Rhode Island Hospital
  • Lexington Pulmonary & Critical Care
  • UT Southwestern Medical Center Heart Lung and Vascular Center
  • University of Texas Medical School
  • Central Utah Clinic, P.C.
  • Intermountain Medical Center
  • University of Virginia
  • Sentara Hospitals T/A Sentara Cardiovascular Research Institute
  • Spokane Respiratory Consultants
  • UW Hospital & Clinics
  • Comprehensive Cardiovascular Care LLP
  • LKH Universitatsklinikum Graz
  • Universitatsklinikum Carl-Gustav-Carus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active / placebo

Placebo / active

Arm Description

Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3

Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3

Outcomes

Primary Outcome Measures

6-minute-walk Distance (6MWD)
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.

Secondary Outcome Measures

Borg Dyspnea Score
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.

Full Information

First Posted
July 1, 2008
Last Updated
September 10, 2015
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00709956
Brief Title
Iloprost Power 15 in Pulmonary Arterial Hypertension
Acronym
PROWESS 15
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Ventavis, iloprost, inhaled treatment, pulmonary arterial hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active / placebo
Arm Type
Experimental
Arm Description
Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3
Arm Title
Placebo / active
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3
Intervention Type
Drug
Intervention Name(s)
iloprost (5 µg)
Other Intervention Name(s)
Ventavis(R)
Intervention Description
Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
Primary Outcome Measure Information:
Title
6-minute-walk Distance (6MWD)
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
Secondary Outcome Measure Information:
Title
Borg Dyspnea Score
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to initiation of any study mandated procedure, Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (HIV) or drugs/toxins in NYHA functional class II to IV. Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug. Exclusion Criteria: Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria, Pulmonary arterial hypertension associated with significant venous or capillary involvement (Pulmonary capillary wedge pressure (PCWP) > 15 mmHg), Known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis, Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 65% of predicted value after bronchodilator administration, Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value, Pregnant or breast-feeding women, Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement), Systolic blood pressure < 95 mmHg, Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C, Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 μmol/L) or ongoing dialysis, Clinically relevant bleeding disorder or active bleeding, For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label, Known hypersensitivity to iloprost or any of its excipients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laila Rouault, MD
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Lung Health & Sleep Enhancement Center, LLC
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pulmonary & Critical Care of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Institute for Medical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mercy Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52245
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7020
Country
United States
Facility Name
The Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Legacy Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Lexington Pulmonary & Critical Care
City
Lexington
State/Province
South Carolina
ZIP/Postal Code
29072
Country
United States
Facility Name
UT Southwestern Medical Center Heart Lung and Vascular Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8550
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Utah Clinic, P.C.
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
VA
Country
United States
Facility Name
Sentara Hospitals T/A Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Spokane Respiratory Consultants
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
UW Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Comprehensive Cardiovascular Care LLP
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
LKH Universitatsklinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitatsklinikum Carl-Gustav-Carus
City
Dresden
ZIP/Postal Code
D-01307
Country
Germany

12. IPD Sharing Statement

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Iloprost Power 15 in Pulmonary Arterial Hypertension

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