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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
United Therapeutics
ClinicalTrials.gov Identifier:
NCT01266265
First received: December 22, 2010
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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
Tyvaso
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
Tyvaso
Other Name: treprostinil
Control
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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266265

  Hide Study Locations
Locations
United States, Alabama
Cardiovascular Associates, P.C.
Birmingham, Alabama, United States, 35213
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
University of South Alabama
Mobile, Alabama, United States, 36693
United States, Arizona
Arizona Pulmonary Specialists, LTD
Phoenix, Arizona, United States, 85013
United States, California
Berkeley Cardiovascular Medical Group
Berkeley, California, United States, 94705
Cedars-Sinai Heart Institute
Beverly Hills, California, United States, 90211
University California San Francisco
Fresno, California, United States, 93721
University of Southern California
Los Angeles, California, United States, 90033
West Los Angeles VA Healthcare Center
Los Angeles, California, United States, 90073
University of California Davis Medical Center
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
Paloma Medical Group
San Juan Capistrano, California, United States, 92675
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Denver
Denver, Colorado, United States, 80045
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, United States, 80033
United States, Florida
St. Francis Sleep Allergy & Lung
Clearwater, Florida, United States, 33765
University of Florida
Gainesville, Florida, United States, 32610
University of Florida College of Medicine Jacksonville
Jacksonville, Florida, United States, 32209
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Pulmonary and Critical Care Associates
Jacksonville, Florida, United States, 32204
Miami Center for Cardiovascular Disease
Miami, Florida, United States, 33136
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States, 32806
Orlando Heart Center
Orlando, Florida, United States, 32806
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Georgia Lung Associates, PC
Austell, Georgia, United States, 30106
United States, Illinois
Northwestern Medical Center
Chicago, Illinois, United States, 60611
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
Midwest Heart Foundation
Oakbrook Terrace, Illinois, United States, 60181
United States, Indiana
Indiana University Hospital
Carmel, Indiana, United States, 46032
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Mercy Hospital
Iowa City, Iowa, United States, 52245
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
William Beaumont Hospital
Troy, Michigan, United States, 48085
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
Nebraska Pulmonary Specialties, LLC
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
SUNY Stony Brook University Medical Center
Islandia, New York, United States, 11790
Winthrop Pulmonary Associates
Mineola, New York, United States, 11501
North Shore - Long Island Jewish Health System
New Hyde Park, New York, United States, 11040
Columbia University Medical Center
New York, New York, United States, 10032
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Mary M Parkes Center
Rochester, New York, United States, 14623
Pulmonary Health Physicians
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States, 28374
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Akron General Hospital
Akron, Ohio, United States, 44302
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0564
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Davis Heart and Lung Research Institute
Columbus, Ohio, United States, 43210
Mercy Fairfield Hospital
Fairfield, Ohio, United States, 45014
United States, Oregon
OHSU-Oregon Health and Science University
Portland, Oregon, United States, 97239
Legacy Pulmonary Northwest
Portland, Oregon, United States, 97210
Oregon Clinic, PC
Portland, Oregon, United States, 97220
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Temple University
Philadelphia, Pennsylvania, United States, 19140
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2582
Berks Schuylkill Respiratory Specialists, Ltd.
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Lexington Pulmonary and Critical Care
Lexington, South Carolina, United States, 29072
United States, Tennessee
MD Total Care, PLLC
Chattanooga, Tennessee, United States, 37419
Summit Medical Group
Knoxville, Tennessee, United States, 37909
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Children's Hospital
Houston, Texas, United States, 77030
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
United Therapeutics
  More Information

No publications provided

Responsible Party: United Therapeutics
ClinicalTrials.gov Identifier: NCT01266265     History of Changes
Other Study ID Numbers: RIN-PH-403
Study First Received: December 22, 2010
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by United Therapeutics:
treprostinil sodium
Tyvaso
Remodulin
Orenitram
oral treprostinil
pulmonary arterial hypertension
PAH
inhalation
Ventavis
iloprost
prostacyclin
epoprostenol sodium
Flolan
Veletri
subcutaneous and intravenous prostacyclin analogue
oral ERA
bosentan
Tracleer
ambrisentan
Letairis
oral PDE5 inhibitors
sildenafil
Revatio
tadalafil
Adcirca
Opsumit
macitentan
Adempas
riociguat

Additional relevant MeSH terms:
Treprostinil
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Bosentan
Epoprostenol
Iloprost
Tezosentan
Sildenafil
Tadalafil
Phosphodiesterase 5 Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 01, 2014