Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
NCT ID: NCT01266265
Last Updated: 2016-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
1333 participants
OBSERVATIONAL
2010-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tyvaso
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
inhaled prostacyclin
Tyvaso
Control
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.
inhaled prostacyclin
As prescribed by the physician
prostacyclin
As prescribed by the physician
subcutaneous and intravenous prostacyclin
As prescribed by physician
oral ERA
As prescribed by physician
oral PDE5 inhibitors
As prescribed by physician
Interventions
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inhaled prostacyclin
Tyvaso
inhaled prostacyclin
As prescribed by the physician
prostacyclin
As prescribed by the physician
subcutaneous and intravenous prostacyclin
As prescribed by physician
oral ERA
As prescribed by physician
oral PDE5 inhibitors
As prescribed by physician
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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Cardiovascular Associates, P.C.
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States
Berkeley Cardiovascular Medical Group
Berkeley, California, United States
Cedars-Sinai Heart Institute
Beverly Hills, California, United States
University California San Francisco
Fresno, California, United States
University of Southern California
Los Angeles, California, United States
West Los Angeles VA Healthcare Center
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Paloma Medical Group
San Juan Capistrano, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
Children's Hospital Denver
Denver, Colorado, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States
St. Francis Sleep Allergy & Lung
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
Pulmonary and Critical Care Associates
Jacksonville, Florida, United States
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Miami Center for Cardiovascular Disease
Miami, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Orlando Heart Center
Orlando, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Georgia Lung Associates, PC
Austell, Georgia, United States
Northwestern Medical Center
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Midwest Heart Foundation
Oakbrook Terrace, Illinois, United States
Indiana University Hospital
Carmel, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Mercy Hospital
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
William Beaumont Hospital
Troy, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Nebraska Pulmonary Specialties, LLC
Lincoln, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
SUNY Stony Brook University Medical Center
Islandia, New York, United States
Winthrop Pulmonary Associates
Mineola, New York, United States
North Shore - Long Island Jewish Health System
New Hyde Park, New York, United States
St. Luke's-Roosevelt Hospital Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Mary M Parkes Center
Rochester, New York, United States
Pulmonary Health Physicians
Syracuse, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Akron General Hospital
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Davis Heart and Lung Research Institute
Columbus, Ohio, United States
Mercy Fairfield Hospital
Fairfield, Ohio, United States
Legacy Pulmonary Northwest
Portland, Oregon, United States
Oregon Clinic, PC
Portland, Oregon, United States
OHSU-Oregon Health and Science University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Lexington Pulmonary and Critical Care
Lexington, South Carolina, United States
MD Total Care, PLLC
Chattanooga, Tennessee, United States
Summit Medical Group
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Aurora Health Care
Milwaukee, Wisconsin, United States
Countries
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References
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Zamanian RT, Levine DJ, Bourge RC, De Souza SA, Rosenzweig EB, Alnuaimat H, Burger C, Mathai SC, Leedom N, DeAngelis K, Lim A, De Marco T. An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension. Pulm Circ. 2016 Sep;6(3):329-37. doi: 10.1086/688059.
Other Identifiers
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RIN-PH-403
Identifier Type: -
Identifier Source: org_study_id
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