Iloprost Power Disc-15 in Pulmonary Arterial Hypertension

NCT00723554 | Terminated Phase 3 Results

• 1 other identifier: AC-063A402
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 36

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

Keywords

pulmonary arterial hypertension; inhaled therapy; power disc-15

Outcome Measures

Primary Outcomes (18)

• Number of Patients Reporting Treatment-emergent Adverse Events (AEs)

  Number of patients reporting at least one treatment-emergent AE/Serious AE

  From the first dose to last dose of investigational product, an average of approximately 268 days, plus 48 hours

• Number of Patients Who Discontinued Iloprost PD-15 Treatment Due to an AE

  Number of patients reporting at least one treatment-emergent AE/Serious AE leading to discontinuation of study investigational treatment

  From the first dose of investigational product to study discontinuation, an average of approximately 268 days

• Number of Patients Reporting Treatment-emergent Serious AEs

  Number of patients reporting at least one treatment-emergent serious AEs

  From the first to last dose of investigational product, an average of approximately 268 days, plus 48 hours

• Systolic Blood Pressure - Iloprost PD-6 (Period 1)

  Systolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15

  Day 1

• Systolic Blood Pressure - Iloprost PD-15 (Period 2)

  Systolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15

  Day 28

• Systolic Blood Pressure - Iloprost PD-15 (Period 3)

  Systolic blood pressure was measured at the end of study visit

  an average of approximately 268 days

• Change in Systolic Blood Pressure - (Period 1 to Period 2)

  Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)

  Day 1 and Day 28

• Change in Systolic Blood Pressure - (Period 1 to Period 3)

  Systolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)

  Day 1 and End of study visit, an average of approximately 268 days

• Diastolic Blood Pressure - Iloprost PD-6 (Period 1)

  Diastolic blood pressure was measured immediately prior to first dosing with Iloprost PD-15

  Day 1

• Diastolic Blood Pressure - Iloprost PD-15 (Period 2)

  Diastolic blood pressure was measured on Day 28 of treatment with Iloprost PD-15

  Day 28

• Diastolic Blood Pressure - Iloprost PD-15 (Period 3)

  Diastolic blood pressure was measured at the end of study visit

  an average of approximately 268 days

• Change in Diastolic Blood Pressure - (Period 1 to Period 2)

  Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)

  Day 1 and Day 28

• Change in Diastolic Blood Pressure - (Period 1 to Period 3)

  Diastolic blood pressure was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)

  Day 1 and End of study visit, an average of approximately 268 days

• Heart Rate - Iloprost PD-6 (Period 1)

  Heart rate was measured immediately prior to first dosing with Iloprost PD-15

  Day 1

• Heart Rate - Iloprost PD-15 (Period 2)

  Heart rate was measured on Day 28 of treatment with Iloprost PD-15

  Day 28

• Heart Rate - Iloprost PD-15 (Period 3)

  Heart rate was measured at the end of study visit

  an average of approximately 268 days

• Change in Heart Rate - (Period 1 to Period 2)

  Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and Day 28 of treatment with Iloprost PD-15 (Period 2)

  Day 1 and Day 28

• Change in Heart Rate - (Period 1 to Period 3)

  Heart rate was measured on Day 1 prior to treatment with Iloprost PD-15 (Period 1) and at the end of treatment with Iloprost PD-15 (Period 3)

  Day 1 and End of study visit, an average of approximately 268 days

Secondary Outcomes (26)

• Average Inhalation Time - Iloprost PD-6 (Period 1)

  average of approximately 28 days

• Average Inhalation Time - Iloprost PD-15 (Period 2)

  average of approximately 28 days

• Average Inhalation Time - Iloprost PD-15 (Period 3)

  average of approximately 240 days

• Change in Average Inhalation Time - (Period 1 to Period 2)

  average approximately 56 days

• Average Number of Days of Dosing - Iloprost PD-6 (Period 1)

  average of approximately 28 days

Study Arms (1)

Iloprost

EXPERIMENTAL

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

Drug: Iloprost PD-6; Drug: Iloprost PD-15

Interventions

Iloprost PD-6 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

Also known as: Ventavis

Iloprost

Iloprost PD-15 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

Also known as: Ventavis

Iloprost

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• : Idiopathic (IPAH)
• : Familial (FPAH)
• : Associated with (APAH)
• : Collagen vascular disease
• : Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair
• : Human immunodeficiency virus (HIV) infection
• : Drugs and toxins
• PAH confirmed by the most recent right heart catheterization showing:
• Mean pulmonary arterial pressure (mPAP)≥ 25 mmHg at rest
• 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.

You may not qualify if:

• PAH belonging to WHO group II-V.
• : Portal hypertension
• : Other (thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders, splenectomy)
• : Associated with significant venous or capillary involvement:
• : Pulmonary veno-occlusive disease (PVOD)
• : 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (36)

University of South Alabama Medical

Mobile, Alabama, 36617, United States

Location

Arizona Pulmonary Associates, Ltd.

Phoenix, Arizona, 85013, United States

Location

Kaiser Foundation Hospital

Los Angeles, California, 90027, United States

Location

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Central Florida Pulmonary Group

Orlando, Florida, 32803, United States

Location

Suncoast Lung Research, LLC

Sarasota, Florida, 34233, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

North Shore Long Island Jewish Health System

New Hyde Park, New York, 11040, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

SUNY Upstate Medical University

Syracus, New York, 13210, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0564, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

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

Columbus, Ohio, 43210, United States

Location

INTEGRIS Baptist Medical Center, Inc.

Oklahoma City, Oklahoma, 73112, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center-Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Central Utah Clinic, P.C.

Provo, Utah, 84604, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

Comprehensive Cardiovascular Care Group LLC

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Wade Benton, PharmD/ Director, Medical Affairs Veletri and Ventavis
• Organization: Actelion Pharmaceuticals, US, Inc.

wade.benton@actelion.com

(650) 624-6900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: April 1, 2011
• Last Updated: April 4, 2013
• Results First Posted: February 15, 2013

Record last verified: 2013-03

Locations

US (36)