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A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution

Description

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.

Phase

N/A

Inclusion and Exclusion 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

  • 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

Sites

  • California

    • Cedars-Sinai Heart Institute, Beverly Hills, California, 90211
    • West Los Angeles VA Healthcare Center, Los Angeles, California, 90073
    • Paloma Medical Group, San Juan Capistrano, California, 92675
    • Santa Barbara Cottage Hospital, Santa Barbara, California, 93105
    • University California San Francisco, Fresno, California, 93721
    • Stanford Hospital and Clinics, Stanford, California, 94305
    • Berkeley Cardiovascular Medical Group, Berkeley, California, 94705
    • University of California Davis Medical Center, Sacramento, California, 95817

  • Arizona

    • Arizona Pulmonary Specialists, LTD, Phoenix, Arizona, 85013

  • Colorado

    • Western States Clinical Research, Inc., Wheat Ridge, Colorado, 80033
    • Children's Hospital Denver, Denver, Colorado, 80045

  • Oregon

    • OHSU-Oregon Health and Science University, Portland, Oregon, 97239
    • Oregon Clinic, PC, Portland, Oregon, 97220
    • Legacy Pulmonary Northwest, Portland, Oregon, 97210

  • Texas

    • Methodist Healthcare System of San Antonio, San Antonio, Texas, 78229
    • UT Southwestern Medical Center, Dallas, Texas, 75390
    • Texas Children's Hospital, Houston, Texas, 77030

  • Nebraska

    • Nebraska Pulmonary Specialties, LLC, Lincoln, Nebraska, 68506

  • Iowa

    • University of Iowa, Iowa City, Iowa, 52242
    • Mercy Hospital, Iowa City, Iowa, 52245

  • Illinois

    • Midwest Heart Foundation, Oakbrook Terrace, Illinois, 60181
    • University of Illinois at Chicago, Chicago, Illinois, 60612
    • Northwestern Medical Center, Chicago, Illinois, 60611

  • Wisconsin

    • Aurora Health Care, Milwaukee, Wisconsin, 53215

  • Alabama

    • University of South Alabama, Mobile, Alabama, 36693
    • The University of Alabama at Birmingham, Birmingham, Alabama, 35294
    • Cardiovascular Associates, P.C., Birmingham, Alabama, 35213

  • Indiana

    • Indiana University Hospital, Carmel, Indiana, 46032

  • Kentucky

    • Kentuckiana Pulmonary Associates, Louisville, Kentucky, 40202

  • Tennessee

    • MD Total Care, PLLC, Chattanooga, Tennessee, 37419

  • Ohio

    • Mercy Fairfield Hospital, Fairfield, Ohio, 45014

  • Georgia

    • Georgia Lung Associates, PC, Austell, Georgia, 30106
    • Emory University School of Medicine, Atlanta, Georgia, 30322
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