Iloprost Power Disc-15 in Pulmonary Arterial Hypertension

NCT ID: NCT00723554

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-04-30

Brief Summary

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®)

Conditions

Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iloprost

The study enrolled patients who were already using iloprost with PD-6 without any safety or tolerability concerns, thereby facilitating a direct comparison of the PD-15 to the PD-6.

The single-arm design allowed each patient to serve as his/her own control

Group Type: EXPERIMENTAL

Iloprost PD-6

Intervention Type: DRUG

Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

Iloprost PD-15

Intervention Type: DRUG

Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive.

Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

Interventions

Iloprost PD-6

Period 1 (PD-6): study period defined as the 14 days prior to the first dose of study iloprost inhalation with PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-6 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

Intervention Type: DRUG

Iloprost PD-15

Period 2 (PD-15): study period between the administration of the first dose with PD-15 on Day 1 until Day 28 inclusive.

Period 3 (PD-15): study period from Day 29 until discontinuation of the PD-15. Commercial iloprost inhalation solution delivered using the Power Disc-15 with the I-neb® Adaptive Aerosol Delivery (AAD®) system administered 6 to 9 times per day

Intervention Type: DRUG

Other Intervention Names

Ventavis; Ventavis

Eligibility Criteria

Inclusion Criteria

• 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
• Premature ovarian failure confirmed by a specialist gynecologist
• XY genotype, Turner syndrome, uterine agenesis
• Is aged > 50 years and not treated with any kind of hormone replacement therapy (HRT) for at least 2 years prior to screening, with amenorrhea for at least 24 consecutive months

• 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.
• History of pulmonary embolism prior to diagnosis of PAH unless it can be documented that chronic thromboembolic pulmonary hypertension (CTEPH) has been specifically excluded (e.g., ventilation/perfusion (VQ) scan, pulmonary angiogram).
• Restrictive lung disease: TLC < 60% of normal predicted value.
• Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) < 0.5 or clinically relevant chronic obstructive lung disease or asthma (including any patient requiring concomitant medication to control symptoms of bronchospasm including as needed (p.r.n.) use).
• Clinically relevant bleeding disorder or active bleeding.
• Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C or hepatic cirrhosis.
• Pregnant or breast-feeding.
• Chronic renal insufficiency, as defined by a creatinine of > 2.5 mg/dL or the requirement for dialysis.
• Hemoglobin < 75% of the lower limit of normal range.
• Any condition that prevents compliance with the protocol or adherence to therapy or ability to provide informed consent.
• Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to enrollment.

Exclusion Criteria

• PAH belonging to WHO group II-V.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

The Ohio State University, The Dorothy M. Davis Heart & Lung Research Institute

Columbus, Ohio, United States

INTEGRIS Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center-Presbyterian

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

Central Utah Clinic, P.C.

Provo, Utah, United States

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Comprehensive Cardiovascular Care Group LLC

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

AC-063A402

Identifier Type: -

Identifier Source: org_study_id