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

Information source: United Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: inhaled prostacyclin (Drug); inhaled prostacyclin (Drug); prostacyclin (Drug); subcutaneous and intravenous prostacyclin (Drug); oral ERA (Drug); oral PDE5 inhibitors (Drug)

Phase: N/A

Status: Completed

Sponsored by: United Therapeutics


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

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Describe the type and incidence of oro-/nasopharyngeal and pulmonary adverse events that may be associated with current or recent treatment with Tyvaso for PAH

Secondary outcome: Compare the incidence of selected oro-/nasopharyngeal and pulmonary adverse events in patients treated with Tyvaso for PAH with patients not treated with Tyvaso for PAH

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.


Minimum age: 1 Year. Maximum age: N/A. Gender(s): Both.


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


- 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


Locations and Contacts

Cardiovascular Associates, P.C., Birmingham, Alabama 35213, United States

The University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

University of South Alabama, Mobile, Alabama 36693, United States

Arizona Pulmonary Specialists, LTD, Phoenix, Arizona 85013, United States

Berkeley Cardiovascular Medical Group, Berkeley, California 94705, United States

Cedars-Sinai Heart Institute, Beverly Hills, California 90211, United States

University California San Francisco, Fresno, California 93721, United States

University of Southern California, Los Angeles, California 90033, United States

West Los Angeles VA Healthcare Center, Los Angeles, California 90073, United States

University of California Davis Medical Center, Sacramento, California 95817, United States

University of California, San Francisco, San Francisco, California 94143, United States

Paloma Medical Group, San Juan Capistrano, California 92675, United States

Santa Barbara Cottage Hospital, Santa Barbara, California 93105, United States

Stanford Hospital and Clinics, Stanford, California 94305, United States

Children's Hospital Denver, Denver, Colorado 80045, United States

Western States Clinical Research, Inc., Wheat Ridge, Colorado 80033, United States

St. Francis Sleep Allergy & Lung, Clearwater, Florida 33765, United States

University of Florida, Gainesville, Florida 32610, United States

Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States

Pulmonary and Critical Care Associates, Jacksonville, Florida 32204, United States

University of Florida College of Medicine Jacksonville, Jacksonville, Florida 32209, United States

Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Miami Center for Cardiovascular Disease, Miami, Florida 33136, United States

Central Florida Pulmonary Group, P.A., Orlando, Florida 32806, United States

Orlando Heart Center, Orlando, Florida 32806, United States

Cleveland Clinic Florida, Weston, Florida 33331, United States

Emory University School of Medicine, Atlanta, Georgia 30322, United States

Georgia Lung Associates, PC, Austell, Georgia 30106, United States

Northwestern Medical Center, Chicago, Illinois 60611, United States

Rush University Medical Center, Chicago, Illinois 60612, United States

University of Illinois at Chicago, Chicago, Illinois 60612, United States

Midwest Heart Foundation, Oakbrook Terrace, Illinois 60181, United States

Indiana University Hospital, Carmel, Indiana 46032, United States

Mercy Hospital, Iowa City, Iowa 52245, United States

University of Iowa, Iowa City, Iowa 52242, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

Kentuckiana Pulmonary Associates, Louisville, Kentucky 40202, United States

Johns Hopkins University, Baltimore, Maryland 21205, United States

University of Maryland, Baltimore, Maryland 21201, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Tufts - New England Medical Center, Boston, Massachusetts 02111, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

William Beaumont Hospital, Troy, Michigan 48085, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Nebraska Pulmonary Specialties, LLC, Lincoln, Nebraska 68506, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center, New Brunswick, New Jersey 08903, United States

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States

SUNY Stony Brook University Medical Center, Islandia, New York 11790, United States

Winthrop Pulmonary Associates, Mineola, New York 11501, United States

North Shore - Long Island Jewish Health System, New Hyde Park, New York 11040, United States

Columbia University Medical Center, New York, New York 10032, United States

St. Luke's-Roosevelt Hospital Center, New York, New York 10019, United States

Mary M Parkes Center, Rochester, New York 14623, United States

Pulmonary Health Physicians, Syracuse, New York 13210, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States

Pinehurst Medical Clinic, Pinehurst, North Carolina 28374, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

Akron General Hospital, Akron, Ohio 44302, United States

University of Cincinnati, Cincinnati, Ohio 45267-0564, United States

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States

Davis Heart and Lung Research Institute, Columbus, Ohio 43210, United States

Mercy Fairfield Hospital, Fairfield, Ohio 45014, United States

Legacy Pulmonary Northwest, Portland, Oregon 97210, United States

OHSU-Oregon Health and Science University, Portland, Oregon 97239, United States

Oregon Clinic, PC, Portland, Oregon 97220, United States

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Temple University, Philadelphia, Pennsylvania 19140, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States

University of Pennsylvania Health System, Philadelphia, Pennsylvania 19104, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213-2582, United States

Berks Schuylkill Respiratory Specialists, Ltd., Wyomissing, Pennsylvania 19610, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Lexington Pulmonary and Critical Care, Lexington, South Carolina 29072, United States

MD Total Care, PLLC, Chattanooga, Tennessee 37419, United States

Summit Medical Group, Knoxville, Tennessee 37909, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

UT Southwestern Medical Center, Dallas, Texas 75390, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Texas Children's Hospital, Houston, Texas 77030, United States

University of Texas Health Science Center at Houston, Houston, Texas 77030, United States

Methodist Healthcare System of San Antonio, San Antonio, Texas 78229, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States

Inova Fairfax Hospital, Falls Church, Virginia 22042, United States

Sentara Cardiovascular Research Institute, Norfolk, Virginia 23507, United States

Aurora Health Care, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: December 2010
Last updated: March 20, 2015

Page last updated: August 23, 2015

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