Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— PROWESS 15 Ext  

Official title:

A Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709098
• Other study ID #: AC-063A302
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2008
• Last updated: September 10, 2015
• Start date: September 2008
• Est. completion date: June 2010

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 (IPAH) or familial (FPAH) pulmonary arterial hypertension in New York Heart Association (NYHA) class II to IV , naive to PAH treatment or currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic pulmonary arterial hypertension (PAH). After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent prior to initiation of any study mandated procedure,

2. Patients with symptomatic idiopathic or familial pulmonary arterial hypertension in NYHA functional class II to IV who have completed study AC-063A301,

3. 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:

1. Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,

2. 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,

3. 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,

4. Moderate to severe restrictive lung disease: total lung capacity (TLC) < 60% of predicted value,

5. Pregnant or breast-feeding women,

6. Systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement),

7. Systolic blood pressure < 95 mmHg,

8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,

9. Chronic renal insufficiency defined by serum creatinine > 2.5 mg/dL (221 µmol/L) or ongoing dialysis,

10. Clinically relevant bleeding disorder or active bleeding,

11. Known hypersensitivity to iloprost or any of its excipients.

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• iloprost
Iloprost 5 mcg delivered by I-neb(R) adaptive aerosol delivery (AAD)(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
• iloprost
Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.

Locations

Country	Name	City	State
Austria	LHK 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 Vacular 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
Other	Average Inhalation Time	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)	12 weeks	No
Primary	Treatment-emergent Adverse Events	Number of adverse events	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.	Yes
Primary	Treatment-emergent Serious Adverse Events	Number of serious adverse events	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.	Yes
Primary	Adverse Events Leading to Premature Discontinuation of Study Drug	Number of adverse events leading to discontinuation of study treatment	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.	Yes
Primary	Patients With Adverse Events Leading to Premature Discontinuation of Study Drug	Number of patients with adverse events leading to discontinuation of study treatment	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.	Yes