Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: inhaled prostacyclin
Drug: prostacyclin
Drug: subcutaneous and intravenous prostacyclin
Drug: oral ERA
Drug: oral PDE5 inhibitors

Registration Number: NCT01266265

Lead Sponsor: United Therapeutics

Brief Summary: A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies

Detailed Description: A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1333

Inclusion Criteria

Clinical diagnosis of PAH, WHO GROUP I
Prescribed and is currently receiving Tyvaso and/or other FDA-approved therapy for the treatment of PAH
Willing and able to provide written informed consent

Exclusion Criteria

Previous initiation and permanent discontinuation of Tyvaso
Participation in an investigational clinical drug or device trial within 30 days of enrollment
Current or past diagnosis of lung neoplasm
Active gastrointestinal or pulmonary bleed at enrollment
Planned surgical intervention for treatment of PAH e.g., atrial septostomy or transplant

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tyvaso	inhaled prostacyclin	The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
Control	inhaled prostacyclin	The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
Control	subcutaneous and intravenous prostacyclin	The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
Control	oral ERA	The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
Control	oral PDE5 inhibitors	The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
Control	prostacyclin	The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.

Primary Outcome Measures

Name	Time	Method
Prevalence of Respiratory Tract-Related Adverse Events of Interest	Follow-up every 3 months	Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (88): Allegheny General Hospital
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Pittsburgh, Pennsylvania, United States
Northwestern Medical Center
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Chicago, Illinois, United States
University of Illinois at Chicago
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Chicago, Illinois, United States
University Hospitals of Cleveland
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Cleveland, Ohio, United States
Tufts - New England Medical Center
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Boston, Massachusetts, United States
University of Southern California
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Los Angeles, California, United States
University California San Francisco
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Fresno, California, United States
Santa Barbara Cottage Hospital
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Santa Barbara, California, United States
Paloma Medical Group
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San Juan Capistrano, California, United States
Johns Hopkins University
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Baltimore, Maryland, United States
West Los Angeles VA Healthcare Center
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Los Angeles, California, United States
Pulmonary and Critical Care Associates
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Jacksonville, Florida, United States
Orlando Heart Center
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Orlando, Florida, United States
Berkeley Cardiovascular Medical Group
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Berkeley, California, United States
Cleveland Clinic Florida
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Weston, Florida, United States
University of California Davis Medical Center
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Sacramento, California, United States
Mercy Fairfield Hospital
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Fairfield, Ohio, United States
Pinehurst Medical Clinic
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Pinehurst, North Carolina, United States
Rush University Medical Center
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Chicago, Illinois, United States
University of Florida College of Medicine Jacksonville
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Jacksonville, Florida, United States
Pulmonary Health Physicians
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Syracuse, New York, United States
Akron General Hospital
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Akron, Ohio, United States
Columbia University Medical Center
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New York, New York, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Miami Center for Cardiovascular Disease
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Miami, Florida, United States
Baylor College of Medicine
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Houston, Texas, United States
Texas Children's Hospital
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Houston, Texas, United States
University of Texas Health Science Center at Houston
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Houston, Texas, United States
University of Cincinnati
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Cincinnati, Ohio, United States
Methodist Healthcare System of San Antonio
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San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States
University of California, San Francisco
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San Francisco, California, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
Arizona Pulmonary Specialists, LTD
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Phoenix, Arizona, United States
Henry Ford Health System
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Detroit, Michigan, United States
Cardiovascular Associates, P.C.
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Birmingham, Alabama, United States
Children's Hospital Denver
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Denver, Colorado, United States
Mayo Clinic
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Rochester, Minnesota, United States
Legacy Pulmonary Northwest
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Portland, Oregon, United States
Oregon Clinic, PC
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Portland, Oregon, United States
OHSU-Oregon Health and Science University
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Portland, Oregon, United States
Aurora Health Care
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Milwaukee, Wisconsin, United States
Berks Schuylkill Respiratory Specialists, Ltd.
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Wyomissing, Pennsylvania, United States
Mercy Hospital
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Iowa City, Iowa, United States
University of South Alabama
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Mobile, Alabama, United States
St. Francis Sleep Allergy & Lung
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Clearwater, Florida, United States
Western States Clinical Research, Inc.
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Wheat Ridge, Colorado, United States
Nebraska Pulmonary Specialties, LLC
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Lincoln, Nebraska, United States
Emory University School of Medicine
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Atlanta, Georgia, United States
University of Iowa
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Iowa City, Iowa, United States
Indiana University Hospital
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Carmel, Indiana, United States
Kentuckiana Pulmonary Associates
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Louisville, Kentucky, United States
UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
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New Brunswick, New Jersey, United States
SUNY Stony Brook University Medical Center
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Islandia, New York, United States
Winthrop Pulmonary Associates
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Mineola, New York, United States
Penn State Milton S. Hershey Medical Center
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Hershey, Pennsylvania, United States
University of Pennsylvania Health System
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Philadelphia, Pennsylvania, United States
Lexington Pulmonary and Critical Care
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Lexington, South Carolina, United States
MD Total Care, PLLC
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Chattanooga, Tennessee, United States
Summit Medical Group
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Knoxville, Tennessee, United States
Cedars-Sinai Heart Institute
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Beverly Hills, California, United States
The University of Alabama at Birmingham
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Birmingham, Alabama, United States
Stanford Hospital and Clinics
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Stanford, California, United States
University of Florida
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Gainesville, Florida, United States
Mount Sinai Medical Center
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Miami Beach, Florida, United States
Mayo Clinic Jacksonville
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Jacksonville, Florida, United States
Georgia Lung Associates, PC
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Austell, Georgia, United States
Central Florida Pulmonary Group, P.A.
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Orlando, Florida, United States
Midwest Heart Foundation
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Oakbrook Terrace, Illinois, United States
Brigham and Women's Hospital
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Boston, Massachusetts, United States
Hackensack University Medical Center
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Hackensack, New Jersey, United States
University of Maryland
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Baltimore, Maryland, United States
William Beaumont Hospital
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Troy, Michigan, United States
Newark Beth Israel Medical Center
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Newark, New Jersey, United States
North Shore - Long Island Jewish Health System
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New Hyde Park, New York, United States
St. Luke's-Roosevelt Hospital Center
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New York, New York, United States
Mary M Parkes Center
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Rochester, New York, United States
University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, United States
Wake Forest University Health Sciences
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Winston-Salem, North Carolina, United States
Davis Heart and Lung Research Institute
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Columbus, Ohio, United States
Temple University
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Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
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Dallas, Texas, United States
Inova Fairfax Hospital
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Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
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Norfolk, Virginia, United States
Thomas Jefferson University
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Philadelphia, Pennsylvania, United States
University of Kansas Medical Center
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Kansas City, Kansas, United States
Rhode Island Hospital
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Providence, Rhode Island, United States