Iloprost Power 15 in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709956
• Other study ID #: AC-063A301
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2008
• Last updated: September 10, 2015
• Start date: July 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2015
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• iloprost (5 µg)
Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc
• placebo
Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc

Locations

Country	Name	City	State
Austria	LKH Universitatsklinikum Graz	Graz
Germany	Universitatsklinikum Carl-Gustav-Carus	Dresden
United States	Central Utah Clinic, P.C.	American Fork	Utah
United States	Pulmonary & Critical Care of Atlanta	Atlanta	Georgia
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	The Lindner Clinical Trial Center	Cincinnati	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	UT Southwestern Medical Center Heart Lung and Vascular Center	Dallas	Texas
United States	Atlanta Institute for Medical Research	Decatur	Georgia
United States	University of Florida	Gainesville	Florida
United States	University of Texas Medical School	Houston	Texas
United States	Mercy Hospital	Iowa City	Iowa
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	UCSD Medical Center	La Jolla	California
United States	Lexington Pulmonary & Critical Care	Lexington	South Carolina
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	UW Hospital & Clinics	Madison	Wisconsin
United States	Comprehensive Cardiovascular Care LLP	Milwaukee	Wisconsin
United States	Winthrop University Hospital	Mineola	New York
United States	Intermountain Medical Center	Murray	Utah
United States	LSU Health Sciences Center	New Orleans	Louisiana
United States	Lung Health & Sleep Enhancement Center, LLC	Newark	Delaware
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Sentara Hospitals T/A Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Legacy Health System	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	UC Davis Medical Center	Sacramento	California
United States	Spokane Respiratory Consultants	Spokane	Washington
United States	Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Study day 2 or study day 3	No
Secondary	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.	Study day 2 or study day 3	No