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Study of Incidence of Respiratory Tract Adverse Events in Patients Treated With Tyvaso® Compared to Other FDA Approved Pulmonary Arterial Hypertension (PAH) Therapies

Information source: United Therapeutics
Information obtained from ClinicalTrials.gov on February 07, 2013
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: Recruiting

Sponsored by: United Therapeutics

Summary

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.

Eligibility

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

Criteria:

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

Locations and Contacts

Cardiovascular Associates, P.C., Birmingham, Alabama 35213, United States; Recruiting
Donna Cole, Phone: 205-599-6385, Email: dcole@cvapc.com
Barry Rayburn, MD, Principal Investigator

The University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
Rachel Culbreth, Phone: 205-934-8767, Email: chfnurse@cardiology.uab.edu
Robert C. Bourge, MD, Principal Investigator

University of South Alabama, Mobile, Alabama 36693, United States; Recruiting
Jennifer Smith, Phone: 251-471-7291, Email: jksmith@usouthal.edu
Karen Fagan, MD, Principal Investigator

Arizona Pulmonary Specialists, LTD, Phoenix, Arizona 85013, United States; Recruiting
Jeremy Feldman, MD, Phone: 602-274-7195
Jeremy Feldman, MD, Principal Investigator

Berkeley Cardiovascular Medical Group, Berkeley, California 94705, United States; Recruiting
Eileen Healy, NP, Phone: 510-204-1691, Email: healye@bcvmg.com
Luisa Munoz, MD, Principal Investigator

Cedars-Sinai Heart Institute, Beverly Hills, California 90211, United States; Recruiting
Tiffany Daun, Phone: 310-248-7129, Email: tiffany.daun@cshs.org
Antoine Hage, MD, Principal Investigator

University California San Francisco, Fresno, California 93721, United States; Recruiting
Sonja Garcia, Phone: 559-459-4042, Email: SGarcia@fresno.ucsf.edu
Vijay Balasubramanian, MD, Principal Investigator

University of Southern California, Los Angeles, California 90033, United States; Recruiting
Lynn Fukushima, Phone: 323-442-9580, Email: Lynn.Fukushima@med.usc.edu
Sivagini Ganesh, MD, Principal Investigator

West Los Angeles VA Healthcare Center, Los Angeles, California 90073, United States; Recruiting
Wendy Hill, Phone: 310-268-4314, Email: Wendy.Hill@va.gov
Shelly Shapiro, MD, Principal Investigator

University of California, San Francisco, San Francisco, California 94143, United States; Recruiting
Leslie Ziani, Phone: 415-476-4014, Email: lziani@medicine.ucsf.edu
Dana McGlothlin, MD, Principal Investigator

Paloma Medical Group, San Juan Capistrano, California 92675, United States; Recruiting
Theresa Schwarz, RN, Phone: 949-443-4114, Email: rn1232@hotmail.com
Michael Rovzar, MD, Principal Investigator

Santa Barbara Cottage Hospital, Santa Barbara, California 93105, United States; Recruiting
Zorina Schultz, Phone: 805-569-7461, Email: zschultz@sbch.org
Jeffery Sager, MD, Principal Investigator

Stanford Hospital and Clinics, Stanford, California 94305, United States; Recruiting
Val Scott, Email: vscott@stanford.edu
Roham Zamanian, MD, Principal Investigator

Children's Hospital Denver, Denver, Colorado 80045, United States; Recruiting
Kathleen Miller-Reed, RN, Phone: 720-777-6427, Email: Miller-Reed.Kathleen@tchden.org
D. Dunbar Ivy, MD, Principal Investigator

Western States Clinical Research, Inc., Wheat Ridge, Colorado 80033, United States; Recruiting
Cheri Casey, Phone: 303-940-9773, Email: cheri@wscrinc.com
Robert Benkert, MD, Principal Investigator

St. Francis Sleep Allergy & Lung, Clearwater, Florida 33765, United States; Recruiting
Ann Gove, Phone: 727-447-3000, Ext: 222, Email: agove@stfrancismed.com
Frank Averill, MD, Principal Investigator

University of Florida, Gainesville, Florida 32610, United States; Recruiting
Christina Eagan, Phone: 352-273-8990, Email: Christina.Eagan@medicine.ufl.edu
Hassan Alnuaimat, MD, Principal Investigator

University of Florida College of Medicine Jacksonville, Jacksonville, Florida 32209, United States; Recruiting
Minal Patel, Phone: 904-244-1106, Email: Minal.Patel@jax.ufl.edu
Abubakr Bawja, MD, Principal Investigator

Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States; Recruiting
Shannon Kennedy, Phone: 904-953-7439, Email: kennedy.shannon@mayo.edu
Charles Burger, MD, Principal Investigator

Pulmonary and Critical Care Associates, Jacksonville, Florida 32204, United States; Recruiting
Ronni Wetmore, Phone: 904-366-3738, Email: rwetmore@paccaweb.com
Mitchell Rothstein, MD, Principal Investigator

Miami Center for Cardiovascular Disease, Miami, Florida 33136, United States; Recruiting
Adriana Silva, Phone: 786-250-9399, Email: adriana0513.as@gmail.com
Javier Jimenez, MD, Principal Investigator

Mount Sinai Medical Center, Miami Beach, Florida 33140, United States; Recruiting
Helen Garcia, Phone: 305-674-2162, Email: helen.garcia@msmc.com
Esteban Escolar, MD, Principal Investigator

Central Florida Pulmonary Group, P.A., Orlando, Florida 32806, United States; Recruiting
Linda Tilme, Email: ltilme@gcrm.com
Daniel Layish, MD, Principal Investigator

Orlando Heart Center, Orlando, Florida 32806, United States; Recruiting
Sally Hewit, Phone: 407-650-1348, Email: SHewit@orlandoheart.com
James Tarver, III, MD, Principal Investigator

Cleveland Clinic Florida, Weston, Florida 33331, United States; Recruiting
Norma Jean Barton, Email: bartonn2@ccf.org
Franck F Rahaghi, MD, Principal Investigator

Emory University School of Medicine, Atlanta, Georgia 30322, United States; Recruiting
Jane Gillespie, Phone: 404-712-8204, Email: jegille@emory.edu
Micah Fisher, MD, Principal Investigator

Georgia Lung Associates, PC, Austell, Georgia 30106, United States; Recruiting
Stacy Beasley, Phone: 770-745-1404, Ext: 4, Email: sbeasley_gcr@yahoo.com
Chad Miller, MD, Principal Investigator

Northwestern Medical Center, Chicago, Illinois 60611, United States; Recruiting
Jinal Gangar, MBBS,MPH, Phone: 312-695-2269, Email: drjinalgangar@northwestern.edu
Michael Cuttica, MD, Principal Investigator

University of Illinois at Chicago, Chicago, Illinois 60612, United States; Recruiting
Nancy Casanova, Phone: 312-355-5934, Email: ngcasan@uic.edu
Roberto Machado, MD, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Joyce Brown, Phone: 312-942-6771, Email: Joyce_Brown@rush.edu
Rajive Tandon, MD, Principal Investigator

Midwest Heart Foundation, Oakbrook Terrace, Illinois 60181, United States; Recruiting
Debbie Heidenreich, Phone: 630-873-3406, Email: dheidenreich@midwestheart.org
Maria Rosa Costanzo, MD, Principal Investigator

Indiana University Hospital, Carmel, Indiana 46032, United States; Recruiting
Betty Logan, MD, Phone: 317-688-3846, Email: blogan@iuhealth.org
William Harvey, MD, Principal Investigator

University of Iowa, Iowa City, Iowa 52242, United States; Recruiting
Tiffany Kriegel, Phone: 319-384-6558, Email: tiffany-kriegel@uiowa.edu
Sif Hansdottir, MD, Principal Investigator

Mercy Hospital, Iowa City, Iowa 52245, United States; Recruiting
Amy Becker, RN, Phone: 319-688-7026, Email: Amy.Becker@mercyic.org
Andrew Ashby, MD, Principal Investigator

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Stephanie Thomas-Dodson, Phone: 913-588-4022, Email: sthomas-dodson@kumc.edu
Tim Williamson, MD, Principal Investigator

Kentuckiana Pulmonary Associates, Louisville, Kentucky 40202, United States; Recruiting
Kim Hobbs, Phone: 502-587-8000, Email: khobbs@kpadocs.com
Wes John McConnell, MD, Principal Investigator

Johns Hopkins University, Baltimore, Maryland 21205, United States; Recruiting
Jude Aidam, Email: jaidam1@jhu.edu
Stephen Mathai, MD, Principal Investigator

University of Maryland, Baltimore, Maryland 21201, United States; Recruiting
Faith Janowick, Phone: 410-328-4433, Email: fjanowic@medicine.umaryland.edu
Myung Park, MD, Principal Investigator

Tufts - New England Medical Center, Boston, Massachusetts 02111, United States; Recruiting
Karen Visnaw, RN, Phone: 617-636-1334, Email: kvisnaw@tuftsmedicalcenter.org
Nicholas Hill, MD, Principal Investigator

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Laurie Lawler, RN, Phone: 617-525-9731, Email: LLAWLER@PARTNERS.ORG
Aaron Waxman, MD, Principal Investigator

Henry Ford Health System, Detroit, Michigan 48202, United States; Recruiting
Marcie Major, Phone: 313-916-2433, Email: MMAJOR1@hfhs.org
Hector Cajigas, MD, Principal Investigator

William Beaumont Hospital, Troy, Michigan 48085, United States; Recruiting
Coleen Tessmar, Phone: 248-964-8524, Email: ctessmar@beaumont.edu
Samuel Allen, MD, Principal Investigator

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Louise Durst, Email: louise.durst@mayo.edu
Robert Frantz, MD, Principal Investigator

Nebraska Pulmonary Specialties, LLC, Lincoln, Nebraska 68506, United States; Recruiting
Lisa Whisenhut, Phone: 402-483-8684, Email: lisaw@npsllc.org
Jeffrey Jarrett, MD, Principal Investigator

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States; Recruiting
Diane Agar, Email: DAgar@HackensackUMC.org
Robert Berkowitz, MD, Principal Investigator

UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center, New Brunswick, New Jersey 08903, United States; Recruiting
Deborah McCloskey, Email: mcclosda@umdnj.edu
Vivien Hsu, MD, Principal Investigator

Newark Beth Israel Medical Center, Newark, New Jersey 07112, United States; Recruiting
Juliet Williams, Phone: 973-926-8578, Email: JuWilliams@SBHCS.com
Sean Studer, MD, Principal Investigator

SUNY Stony Brook University Medical Center, Islandia, New York 11790, United States; Recruiting
Jacqueline Skarre, Email: jacqueline.skarre@stonybrook.edu
Paul Strachan, MD, Principal Investigator

Winthrop Pulmonary Associates, Mineola, New York 11501, United States; Recruiting
Kim Byrnes, LPN, Email: kbyrnes@winthrop.org
Shilpa Ann DeSouza, MD, Principal Investigator

North Shore - Long Island Jewish Health System, New Hyde Park, New York 11040, United States; Recruiting
Rebecca Miller, Phone: 516-465-5447, Email: rmiller6@nshs.edu
Arunabh Talwar, MD, Principal Investigator

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Katherine Whee, Phone: 212-305-4436, Email: kl2454@columbia.edu
Erika Berman-Rosenzweig, MD, Principal Investigator

St. Luke's-Roosevelt Hospital Center, New York, New York 10019, United States; Recruiting
Lori Tartell, Phone: 212-523-5471, Email: LTARTELL@CHPNET.ORG
Ruth Minkin, MD, Principal Investigator

Mary M Parkes Center, Rochester, New York 14623, United States; Recruiting
Toni Heininger, Phone: 585-486-0147, Ext: 123, Email: antonia_heininger@urmc.rochester.edu
R. James White, MD, Principal Investigator

Pulmonary Health Physicians, Syracuse, New York 13210, United States; Recruiting
Cathy Fogus, Phone: 315-234-0816, Email: cathy.fogus@cnylungs.com
Sherif El Bayadi, MD, Principal Investigator

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
Sarah McGee, Phone: 919-966-2531, Email: smcgee@med.unc.edu
Hubert Ford, MD, Principal Investigator

Pinehurst Medical Clinic, Pinehurst, North Carolina 28374, United States; Recruiting
Brenda Sanders, Phone: 910-235-3142, Email: basanders@pinehurstmedical.com
Michael Pritchett, MD, Principal Investigator

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States; Recruiting
Gayle Marterre, Phone: 336-716-0573, Email: gmarterr@wakehealth.edu
Rodolfo Pascual, MD, Principal Investigator

Akron General Hospital, Akron, Ohio 44302, United States; Recruiting
Debbie Hudock, Phone: 330-344-1570, Email: dhudock@agmc.org
Michael Passero, MD, Principal Investigator

University of Cincinnati, Cincinnati, Ohio 45267-0564, United States; Recruiting
Tammy Roads, Phone: 513-558-2148, Email: roadst@ucmail.uc.edu
Jean Elwing, MD, Principal Investigator

University Hospitals of Cleveland, Cleveland, Ohio 44106, United States; Recruiting
David Haney, Phone: 216-844-2381, Email: david.haney@uhhospitals.org
Robert Schliz, MD, Principal Investigator

Davis Heart and Lung Research Institute, Columbus, Ohio 43210, United States; Recruiting
Laura Yamokoski, Phone: 614-247-7793, Email: Laura.Yamokoski@osumc.edu
Veronica Franco, MD, Principal Investigator

Mercy Fairfield Hospital, Fairfield, Ohio 45014, United States; Recruiting
MaryLou Sauer, Phone: 513-603-8236, Email: smdsauer@yahoo.com
Lynne Wagoner, MD, Principal Investigator

OHSU-Oregon Health and Science University, Portland, Oregon 97239, United States; Recruiting
Kristen Baptiste, Email: baptiste@ohsu.edu
Akram Khan, MD, Principal Investigator

Legacy Pulmonary Northwest, Portland, Oregon 97210, United States; Recruiting
Tamara Mayfield, Phone: 503-413-7945, Email: TMayfiel@LHS.ORG
Catherine Markin, MD, Principal Investigator

Oregon Clinic, PC, Portland, Oregon 97220, United States; Recruiting
Meg Day, Phone: 503-963-3182, Email: mday@orclinic.com
Rhett Cummings, MD, Principal Investigator

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States; Recruiting
Robert Vender, MD, Email: rvender@hmc.psu.edu
Robert Vender, MD, Principal Investigator

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Recruiting
Paul Park, Phone: 215-503-4070, Email: paul.park@jefferson.edu
Michael Scharf, MD, Principal Investigator

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Jeannie Acampora, Email: acampora@email.chop.edu
Brian Hanna, MD, Principal Investigator

Temple University, Philadelphia, Pennsylvania 19140, United States; Recruiting
Melody Santiago, Email: Melody.Santiago@tuhs.temple.edu
Shelia Weaver, MD, Principal Investigator

University of Pennsylvania Health System, Philadelphia, Pennsylvania 19104, United States; Recruiting
Christine Malloy, Phone: 215-513-2999, Email: christine.malloy@uphs.upenn.edu
Eduardo Rame, MD, Principal Investigator

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Pranav Ravi, Phone: 412-359-6691, Email: pravi@wpahs.org
Raymond Benza, MD, Principal Investigator

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213-2582, United States; Recruiting
Paula M. McGrath, Phone: 412-692-2769, Email: McGrathPM@upmc.edu
Michael Mathier, MD, Principal Investigator

Berks Schuylkill Respiratory Specialists, Ltd., Wyomissing, Pennsylvania 19610, United States; Recruiting
Lisa Hill, Phone: 610-685-5864, Ext: 166, Email: lhill@lungmd.net
Alec Platt, MD, Principal Investigator

Rhode Island Hospital, Providence, Rhode Island 02903, United States; Recruiting
Barbara Smithson, Phone: 401-444-9097, Email: BSmithson@Lifespan.org
James Klinger, MD, Principal Investigator

Lexington Pulmonary and Critical Care, Lexington, South Carolina 29072, United States; Recruiting
Christina Derienzo, RN, Phone: 803-394-7279, Email: cderienzo@lexpcc.net
Donald Elton, MD, Principal Investigator

MD Total Care, PLLC, Chattanooga, Tennessee 37419, United States; Recruiting
Eva Malaspino, Phone: 423-710-3864, Email: clinicaltrails_MDTC@earthlink.net
Michael Czarnecki, MD, Principal Investigator

Summit Medical Group, Knoxville, Tennessee 37909, United States; Recruiting
Monica Goins, Phone: 423-989-3105, Email: mgoins@pmg-research.com
John Swisher, MD, Principal Investigator

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Shelly Gonzalez, Phone: 615-343-8277, Email: rochelle.gonzalez@Vanderbilt.Edu
Ivan Robbins, MD, Principal Investigator

UT Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Yvonne Pena, Phone: 214-645-7148, Email: Yvonne.Pena@UTSouthwestern.edu
Sonja Bartolome, MD, Principal Investigator

Texas Children's Hospital, Houston, Texas 77030, United States; Recruiting
Charles Sellers, Phone: 832-822-4790, Email: cxseller@texaschildrens.org
Fadel Ruiz, MD, Principal Investigator

University of Texas Health Science Center at Houston, Houston, Texas 77030, United States; Recruiting
Kristi Baysinger, Phone: 713-500-6851, Email: Kristi.L.Baysinger@uth.tmc.edu
Bela Patel, MD, Principal Investigator

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Jennifer L Lee, Phone: 713-798-2400, Email: jllee@bcm.edu
Zeenat Safdar, MD, Principal Investigator

University of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States; Recruiting
Regina Whitener, RN, Phone: 210-617-5300, Ext: 14549, Email: WHITENER@uthscsa.edu
Deborah Levine, MD, Principal Investigator

Methodist Healthcare System of San Antonio, San Antonio, Texas 78229, United States; Recruiting
Gloria Carreon, Phone: 210-575-3064, Email: Gloria.Carreon@MHShealth.com
Michael Kwan, MD, Principal Investigator

Inova Fairfax Hospital, Falls Church, Virginia 22042, United States; Recruiting
Mary Smith, Phone: 703-776-7128, Email: marya.smith@inova.org
Oksana Shlobin, MD, Principal Investigator

Sentara Cardiovascular Research Institute, Norfolk, Virginia 23507, United States; Recruiting
Melinda Bullivant, RN, MSN, Phone: 757-388-4024, Email: MMBULLIV@sentara.com
Michael Eggert, MD, Principal Investigator

Aurora Health Care, Milwaukee, Wisconsin 53215, United States; Recruiting
Valerie Zindars, RN, Phone: 414-649-6853, Email: valerie.zindars@aurora.org
Dianne Zwicke, MD, Principal Investigator

Additional Information

Starting date: December 2010
Last updated: October 5, 2012

Page last updated: February 07, 2013

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