Iloprost Power 15 in Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Drug: placebo
- Registration Number
- NCT00709956
- Lead Sponsor
- Actelion
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo / active iloprost (5 µg) Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3 Active / placebo iloprost (5 µg) Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 Active / placebo placebo Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 Placebo / active placebo Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3
- Primary Outcome Measures
Name Time Method 6-minute-walk Distance (6MWD) Study day 2 or study day 3 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
Name Time Method Borg Dyspnea Score Study day 2 or study day 3 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.
Trial Locations
- Locations (34)
Pulmonary & Critical Care of Atlanta
🇺🇸Atlanta, Georgia, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center Heart Lung and Vascular Center
🇺🇸Dallas, Texas, United States
University of Texas Medical School
🇺🇸Houston, Texas, United States
UCSD Medical Center
🇺🇸La Jolla, California, United States
Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA
🇺🇸Torrance, California, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Lung Health & Sleep Enhancement Center, LLC
🇺🇸Newark, Delaware, United States
Atlanta Institute for Medical Research
🇺🇸Decatur, Georgia, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
Mercy Hospital
🇺🇸Iowa City, Iowa, United States
LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
The Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Central Utah Clinic, P.C.
🇺🇸American Fork, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Spokane Respiratory Consultants
🇺🇸Spokane, Washington, United States
UW Hospital & Clinics
🇺🇸Madison, Wisconsin, United States
Comprehensive Cardiovascular Care LLP
🇺🇸Milwaukee, Wisconsin, United States
LKH Universitatsklinikum Graz
🇦🇹Graz, Austria
Universitatsklinikum Carl-Gustav-Carus
🇩🇪Dresden, Germany
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Legacy Health System
🇺🇸Portland, Oregon, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Sentara Hospitals T/A Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Lexington Pulmonary & Critical Care
🇺🇸Lexington, South Carolina, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States