Trial record 1 of 1 for:    treprostinil | RIN-PH-403 | United States, Florida
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Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies (Aspire)

This study is currently recruiting participants.
Verified February 2014 by United Therapeutics
Information provided by (Responsible Party):
United Therapeutics Identifier:
First received: December 22, 2010
Last updated: February 28, 2014
Last verified: February 2014

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

Condition Intervention
Pulmonary Arterial Hypertension
Drug: inhaled prostacyclin
Drug: prostacyclin
Drug: subcutaneous and intravenous prostacyclin
Drug: oral ERA
Drug: oral PDE5 inhibitors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution

Resource links provided by NLM:

Further study details as provided by United Therapeutics:

Primary Outcome Measures:
  • 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 [ Time Frame: Follow-up every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Follow-up every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1320
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
Drug: inhaled prostacyclin
Other Name: treprostinil
The control group will consist of patients receiving any FDA approved PAH therapy as part of routine care.
Drug: inhaled prostacyclin
As prescribed by the physician
Other Name: iloprost, Ventavis
Drug: prostacyclin
As prescribed by the physician
Other Name: epoprostenol sodium, Flolan
Drug: subcutaneous and intravenous prostacyclin
As prescribed by physician
Other Name: treprostinil , Remodulin
Drug: oral ERA
As prescribed by physician
Other Names:
  • bosentan, Tracleer
  • ambrisentan, Letairis
Drug: oral PDE5 inhibitors
As prescribed by physician
Other Names:
  • sildenafil, Revatio
  • tadalafil, Adcirca

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.


Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community centers, academic institutions


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
  Contacts and Locations
Please refer to this study by its identifier: NCT01266265

Contact: Nicole H Leedom 919-425-5870

  Hide Study Locations
United States, Alabama
Cardiovascular Associates, P.C. Recruiting
Birmingham, Alabama, United States, 35213
Contact: Suzanne Frew, RN    205-599-6385   
Contact: Tammy Stover, RN    (205)599-2259   
Principal Investigator: Barry Rayburn, MD         
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Leigh Powell, MSN, BSN, RN, CCRC    205-975-9859   
Principal Investigator: Robert C. Bourge, MD         
University of South Alabama Recruiting
Mobile, Alabama, United States, 36693
Contact: Jennifer Smith    251-471-7291   
Principal Investigator: Karen Fagan, MD         
United States, Arizona
Arizona Pulmonary Specialists, LTD Completed
Phoenix, Arizona, United States, 85013
United States, California
Berkeley Cardiovascular Medical Group Recruiting
Berkeley, California, United States, 94705
Contact: Eileen Healy, NP    510-204-1691   
Principal Investigator: Luisa Munoz, MD         
Cedars-Sinai Heart Institute Recruiting
Beverly Hills, California, United States, 90211
Contact: Lucilla Garcia    310-248-7134   
Principal Investigator: Antoine Hage, MD         
University California San Francisco Recruiting
Fresno, California, United States, 93721
Contact: Sonja Garcia    559-459-4042   
Principal Investigator: Vijay Balasubramanian, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Lynn Fukushima    323-442-9580   
Principal Investigator: Sivagini Ganesh, MD         
West Los Angeles VA Healthcare Center Recruiting
Los Angeles, California, United States, 90073
Contact: Wendy Hill    310-268-4314   
Principal Investigator: Shelly Shapiro, MD         
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Kirsten Alman    916-734-5581   
Principal Investigator: Roblee P. Allen, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Leslie Ziani    415-476-4014   
Principal Investigator: Teresa DeMarco, MD         
Paloma Medical Group Recruiting
San Juan Capistrano, California, United States, 92675
Contact: Theresa Schwarz, RN    949-443-4114   
Principal Investigator: Michael Rovzar, MD         
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Contact: Zorina Schultz    805-569-7461   
Principal Investigator: Jeffery Sager, MD         
Stanford Hospital and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Patricia Del Rosario    650-721-2408   
Principal Investigator: Roham Zamanian, MD         
United States, Colorado
Children's Hospital Denver Recruiting
Denver, Colorado, United States, 80045
Contact: Kathleen Miller-Reed, RN    720-777-6427   
Principal Investigator: D. Dunbar Ivy, MD         
Western States Clinical Research, Inc. Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Cheri Casey    303-940-9773   
Principal Investigator: Robert Benkert, MD         
United States, Florida
St. Francis Sleep Allergy & Lung Recruiting
Clearwater, Florida, United States, 33765
Contact: Ann Gove    727-447-3000 ext 222   
Principal Investigator: Frank Averill, MD         
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Christina Eagan    352-273-8990   
Principal Investigator: Hassan Alnuaimat, MD         
University of Florida College of Medicine Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Minal Patel    904-244-1106   
Principal Investigator: Abubakr Bawja, MD         
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Shannon Kennedy    904-953-7439   
Principal Investigator: Charles Burger, MD         
Pulmonary and Critical Care Associates Recruiting
Jacksonville, Florida, United States, 32204
Contact: Ronni Wetmore    904-366-3738   
Principal Investigator: Mitchell Rothstein, MD         
Miami Center for Cardiovascular Disease Recruiting
Miami, Florida, United States, 33136
Contact: Tisha Diaz    786-250-9399   
Contact    305-666-4633 ext 254      
Principal Investigator: Javier Jimenez, MD         
Mount Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Helen Garcia    305-674-2162   
Principal Investigator: Esteban Escolar, MD         
Central Florida Pulmonary Group, P.A. Recruiting
Orlando, Florida, United States, 32806
Contact: Linda Tilme   
Principal Investigator: Daniel Layish, MD         
Orlando Heart Center Recruiting
Orlando, Florida, United States, 32806
Contact: Sally Hewit    407-650-1348   
Principal Investigator: James Tarver, III, MD         
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Norma Jean Barton   
Principal Investigator: Franck F Rahaghi, MD         
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Jane Gillespie    404-712-8204   
Principal Investigator: Micah Fisher, MD         
Georgia Lung Associates, PC Recruiting
Austell, Georgia, United States, 30106
Contact: Stacy Beasley    770-745-1404 ext 4   
Principal Investigator: Chad Miller, MD         
United States, Illinois
Northwestern Medical Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Clare Marlin    312-695-2269   
Principal Investigator: Michael Cuttica, MD         
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Yvonne Valencia    312-996-9191   
Principal Investigator: Roberto Machado, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Joyce Brown    312-942-6771   
Principal Investigator: Rajive Tandon, MD         
Midwest Heart Foundation Recruiting
Oakbrook Terrace, Illinois, United States, 60181
Contact: Alicja (Alice) Szydlowska    630-255-2348   
Principal Investigator: Maria Rosa Costanzo, MD         
United States, Indiana
Indiana University Hospital Recruiting
Carmel, Indiana, United States, 46032
Contact: Betty Logan, MD    317-688-3846   
Principal Investigator: William Harvey, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Cynthia Larew    319-353-7953   
Principal Investigator: Sif Hansdottir, MD         
Mercy Hospital Recruiting
Iowa City, Iowa, United States, 52245
Contact: Amy Becker, RN    319-688-7026   
Principal Investigator: Vikas Sharotri, MD         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Marla Watson    913-588-4022   
Principal Investigator: Leslie Spikes, MD         
United States, Kentucky
Kentuckiana Pulmonary Associates Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kim Hobbs    502-587-8000   
Principal Investigator: Wes John McConnell, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Zeling Cao    410-614-2006   
Principal Investigator: Stephen Mathai, MD         
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Faith Pa'ahana-Brown    410-328-4433   
Principal Investigator: Myung Park, MD         
United States, Massachusetts
Tufts - New England Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Karen Visnaw, RN    617-636-1334   
Principal Investigator: Nicholas Hill, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Laurie Lawler, RN    617-525-9731    LLAWLER@PARTNERS.ORG   
Principal Investigator: Aaron Waxman, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Beverly Stallings    313-916-1254   
Principal Investigator: Hector Cajigas, MD         
William Beaumont Hospital Recruiting
Troy, Michigan, United States, 48085
Contact: Coleen Tessmar    248-964-8524   
Principal Investigator: Samuel Allen, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Annette McNallan    507-266-3639   
Principal Investigator: Robert Frantz, MD         
United States, Nebraska
Nebraska Pulmonary Specialties, LLC Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Lisa Whisenhunt    402-483-8684   
Principal Investigator: Jeffrey Jarrett, MD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Diane Agar   
Principal Investigator: Robert Berkowitz, MD         
UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Deborah McCloskey   
Principal Investigator: Vivien Hsu, MD         
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Juliet Williams    973-926-8578   
Principal Investigator: Christina Migliore, MD         
United States, New York
SUNY Stony Brook University Medical Center Recruiting
Islandia, New York, United States, 11790
Contact: Jacqueline Skarre   
Principal Investigator: Paul Strachan, MD         
Winthrop Pulmonary Associates Recruiting
Mineola, New York, United States, 11501
Contact: Kim Byrnes, LPN   
Principal Investigator: Shilpa Ann DeSouza, MD         
North Shore - Long Island Jewish Health System Recruiting
New Hyde Park, New York, United States, 11040
Contact: Sameer Verma    516-465-5437   
Principal Investigator: Arunabh Talwar, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jane Devereux    212-305-4436   
Principal Investigator: Erika Berman-Rosenzweig, MD         
St. Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Lori Tartell    212-523-5471    LTARTELL@CHPNET.ORG   
Principal Investigator: Ruth Minkin, MD         
Mary M Parkes Center Recruiting
Rochester, New York, United States, 14623
Contact: Chris Weaver    585-273-4351 ext 123   
Principal Investigator: R. James White, MD         
Pulmonary Health Physicians Recruiting
Syracuse, New York, United States, 13210
Contact: Cathy Fogus    315-234-0816   
Principal Investigator: Sherif El Bayadi, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Sarah McGee    919-966-2531   
Principal Investigator: Hubert Ford, MD         
Pinehurst Medical Clinic Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Joann McSorley    910-235-3144   
Principal Investigator: Michael Pritchett, MD         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Gayle Marterre    336-716-0573   
Principal Investigator: Rodolfo Pascual, MD         
United States, Ohio
Akron General Hospital Recruiting
Akron, Ohio, United States, 44302
Contact: Debbie Hudock    330-344-1570   
Principal Investigator: Michael Passero, MD         
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267-0564
Contact: Stephanie Hartke    513-558-2148   
Principal Investigator: Jean Elwing, MD         
University Hospitals of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: David Haney    216-844-2381   
Principal Investigator: Robert Schliz, MD         
Davis Heart and Lung Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca Anderson    614-247-7793   
Principal Investigator: Veronica Franco, MD         
Mercy Fairfield Hospital Recruiting
Fairfield, Ohio, United States, 45014
Contact: MaryLou Sauer    513-603-8236   
Principal Investigator: Lynne Wagoner, MD         
United States, Oregon
OHSU-Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Nathan Kessler    503-494-9570   
Principal Investigator: Akram Khan, MD         
Legacy Pulmonary Northwest Recruiting
Portland, Oregon, United States, 97210
Contact: Tamara Mayfield    503-413-7945    TMayfiel@LHS.ORG   
Principal Investigator: Catherine Markin, MD         
Oregon Clinic, PC Recruiting
Portland, Oregon, United States, 97220
Contact: Meg Day    503-963-3182   
Principal Investigator: Rhett Cummings, MD         
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Robert Vender, MD   
Principal Investigator: Robert Vender, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Paul Park    215-503-4070   
Principal Investigator: Michael Scharf, MD         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kevin Gralewski    267-426-3159   
Principal Investigator: Brian Hanna, MD         
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Melody Santiago   
Principal Investigator: Shelia Weaver, MD         
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christine Malloy    215-513-2999   
Principal Investigator: Eduardo Rame, MD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Lauren Machen    412-359-6181   
Principal Investigator: Raymond Benza, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213-2582
Contact: Mary Pollera    412-647-2820   
Principal Investigator: Michael Mathier, MD         
Berks Schuylkill Respiratory Specialists, Ltd. Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact: Lisa Hill    610-685-5864 ext 166   
Principal Investigator: Alec Platt, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Barbara Smithson    401-444-9097   
Principal Investigator: James Klinger, MD         
United States, South Carolina
Lexington Pulmonary and Critical Care Completed
Lexington, South Carolina, United States, 29072
United States, Tennessee
MD Total Care, PLLC Completed
Chattanooga, Tennessee, United States, 37419
Summit Medical Group Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Monica Goins    423-989-3105   
Principal Investigator: John Swisher, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Shelly Gonzalez    615-343-8277    rochelle.gonzalez@Vanderbilt.Edu   
Principal Investigator: Ivan Robbins, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Yvonne Pena    214-645-7148   
Principal Investigator: Sonja Bartolome, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Charles Sellers    832-822-4790   
Principal Investigator: Fadel Ruiz, MD         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Kristi Baysinger    713-500-6851   
Principal Investigator: Bela Patel, MD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Jennifer L Lee    713-798-2400   
Principal Investigator: Zeenat Safdar, MD         
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Regina Whitener, RN    210-617-5300 ext 14549   
Principal Investigator: Deborah Levine, MD         
Methodist Healthcare System of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Gloria Carreon    210-575-3064   
Principal Investigator: Michael Kwan, MD         
United States, Virginia
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Contact: Mary Smith    703-776-7128   
Principal Investigator: Oksana Shlobin, MD         
Sentara Cardiovascular Research Institute Recruiting
Norfolk, Virginia, United States, 23507
Contact: Melinda Bullivant, RN, MSN    757-388-4024   
Principal Investigator: Michael Eggert, MD         
United States, Wisconsin
Aurora Health Care Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Valerie Zindars, RN    414-649-6853   
Principal Investigator: Dianne Zwicke, MD         
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics Identifier: NCT01266265     History of Changes
Other Study ID Numbers: RIN-PH-403
Study First Received: December 22, 2010
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
treprostinil sodium
oral treprostinil
pulmonary arterial hypertension
epoprostenol sodium
subcutaneous and intravenous prostacyclin analogue
oral ERA
oral PDE5 inhibitors

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Phosphodiesterase 5 Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 17, 2014