Iloprost Power Disc-15 in Pulmonary Arterial Hypertension

Stopped early · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

A Phase IIIb, Multicenter, Open-Label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 to Power Disc-15 With the I-neb® Adaptive Aerosol Delivery® System (I-neb® AAD®)

Key facts

Study ID

NCT00723554

Run by

Actelion

People needed

63

Starts

2008-07-01

Expected to finish

2011-04-01

Last updated by the study team

2013-04-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent prior to initiation of any study-mandated procedure.
• Male or female patients aged 18-85 years.
• Patients with symptomatic pulmonary arterial hypertension in New York Heart Association (NYHA) functional class III or IV at the time of initiation of iloprost inhalation (Ventavis®) therapy using the Power Disc-6 (PD-6).
• Patients with the following types of pulmonary arterial hypertension (PAH) belonging to World Health Organization (WHO) Group I:
• 1.1: Idiopathic (IPAH)
• 1.2: Familial (FPAH)
• 1.3: Associated with (APAH)
• 1.3.1: Collagen vascular disease
• 1.3.2: Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair
• 1.3.4: Human immunodeficiency virus (HIV) infection
• 1.3.5: Drugs and toxins
• PAH confirmed by the most recent right heart catheterization showing:
• Mean pulmonary arterial pressure (mPAP)≥ 25 mmHg at rest
• Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≤ 15 mmHg. If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion.
• Pulmonary vascular resistance (PVR) > 240 dyn-sec/cm\^5
• Compliant with a treatment regimen of commercial iloprost inhalation (Ventavis® 5 μg) using the I-neb® AAD® equipped with the PD-6 for at least 4 weeks prior to screening.
• Pulmonary function tests (PFTs) including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and total lung capacity (TLC), performed within 6 months of screening.
• If taking other medications for PAH, these must have been stable for 60 days prior to baseline.
• If taking corticosteroids, these must have been stable for 60 days prior to baseline.
• Women of childbearing potential with a negative urine pre-treatment pregnancy test at baseline and who:
• consistently and correctly use (from screening and up to 28 days after discontinuation of study drug) a reliable method of contraception with a Pearl index of < 1%,
• are sexually abstinent, or
• have a vasectomized partner.
• A woman is considered to have childbearing potential unless she meets at least one of the following criteria:
• Previous bilateral salpingo-oophorectomy or hysterectomy

You may not qualify if…

• PAH belonging to WHO group II-V.
• PAH belonging to WHO group I other than that listed in the inclusion criteria, i.e., PAH associated with:
• 1.3.3: Portal hypertension
• 1.3.6: Other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy)
• 1.4: Associated with significant venous or capillary involvement:
• 1.4.1: Pulmonary veno-occlusive disease (PVOD)
• 1.4.2: Pulmonary capillary hemangiomatosis (PCH).
• Receipt of any prostacyclin or prostacyclin analog other than iloprost within 12 weeks before screening.
• Anticipation of the need for intravenous prostacyclin use within 28 days of starting the Power Disc-15 (PD-15).
• HIV-seropositive with any of the following:
• Concomitant active opportunistic infections within 6 months prior to screening
• Detectable viral load within 6 months of screening
• CD4+ T-cell count < 200 mm\^3 within 3 months of screening
• Changes in antiretroviral regimen within 3 months of screening
• Anticipated changes in antiretroviral regimen during study periods 1 or 2
• Using inhaled pentamidine
• Systemic hypotension with systolic blood pressure < 95 mmHg.
• Uncontrolled systemic hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg on repeated measurement).
• History of left-sided heart disease, including any of the following:
• hemodynamically significant aortic or mitral valve disease
• restrictive or congestive cardiomyopathy
• left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
• coronary artery disease with continuing symptoms of angina pectoris
• life-threatening cardiac arrhythmias
• Atrial septostomy within 1 year.

Where it is running

• University of South Alabama Medical — Mobile, Alabama, United States
• Arizona Pulmonary Associates, Ltd. — Phoenix, Arizona, United States
• Kaiser Foundation Hospital — Los Angeles, California, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, California, United States
• University of Florida — Gainesville, Florida, United States
• Central Florida Pulmonary Group — Orlando, Florida, United States
• Suncoast Lung Research, LLC — Sarasota, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Kentuckiana Pulmonary Associates — Louisville, Kentucky, United States
• LSU Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Winthrop University Hospital — Mineola, New York, United States
• North Shore Long Island Jewish Health System — New Hyde Park, New York, United States
• Beth Israel Medical Center — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• SUNY Upstate Medical University — Syracus, New York, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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