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NCT01266265 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

— Aspire  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01266265
Other study ID # RIN-PH-403
Secondary ID
Status Completed
Phase N/A
First received December 22, 2010
Last updated January 20, 2016
Start date December 2010
Est. completion date December 2014

Study information
Verified date January 2016
Source United Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1333
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• inhaled prostacyclin
Tyvaso
• inhaled prostacyclin
As prescribed by the physician
• prostacyclin
As prescribed by the physician
• subcutaneous and intravenous prostacyclin
As prescribed by physician
• oral ERA
As prescribed by physician
• oral PDE5 inhibitors
As prescribed by physician

Locations
Country Name City State
United States Akron General Hospital Akron Ohio
United States Emory University School of Medicine Atlanta Georgia
United States Georgia Lung Associates, PC Austell Georgia
United States Johns Hopkins University Baltimore Maryland
United States University of Maryland Baltimore Maryland
United States Berkeley Cardiovascular Medical Group Berkeley California
United States Cedars-Sinai Heart Institute Beverly Hills California
United States Cardiovascular Associates, P.C. Birmingham Alabama
United States The University of Alabama at Birmingham Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Tufts - New England Medical Center Boston Massachusetts
United States Indiana University Hospital Carmel Indiana
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States MD Total Care, PLLC Chattanooga Tennessee
United States Northwestern Medical Center Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States St. Francis Sleep Allergy & Lung Clearwater Florida
United States University Hospitals of Cleveland Cleveland Ohio
United States Davis Heart and Lung Research Institute Columbus Ohio
United States UT Southwestern Medical Center Dallas Texas
United States Children's Hospital Denver Denver Colorado
United States Henry Ford Health System Detroit Michigan
United States Mercy Fairfield Hospital Fairfield Ohio
United States Inova Fairfax Hospital Falls Church Virginia
United States University California San Francisco Fresno California
United States University of Florida Gainesville Florida
United States Hackensack University Medical Center Hackensack New Jersey
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States Baylor College of Medicine Houston Texas
United States Texas Children's Hospital Houston Texas
United States University of Texas Health Science Center at Houston Houston Texas
United States Mercy Hospital Iowa City Iowa
United States University of Iowa Iowa City Iowa
United States SUNY Stony Brook University Medical Center Islandia New York
United States Mayo Clinic Jacksonville Jacksonville Florida
United States Pulmonary and Critical Care Associates Jacksonville Florida
United States University of Florida College of Medicine Jacksonville Jacksonville Florida
United States University of Kansas Medical Center Kansas City Kansas
United States Summit Medical Group Knoxville Tennessee
United States Lexington Pulmonary and Critical Care Lexington South Carolina
United States Nebraska Pulmonary Specialties, LLC Lincoln Nebraska
United States University of Southern California Los Angeles California
United States West Los Angeles VA Healthcare Center Los Angeles California
United States Kentuckiana Pulmonary Associates Louisville Kentucky
United States Miami Center for Cardiovascular Disease Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Aurora Health Care Milwaukee Wisconsin
United States Winthrop Pulmonary Associates Mineola New York
United States University of South Alabama Mobile Alabama
United States Vanderbilt University Medical Center Nashville Tennessee
United States UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center New Brunswick New Jersey
United States North Shore - Long Island Jewish Health System New Hyde Park New York
United States Columbia University Medical Center New York New York
United States St. Luke's-Roosevelt Hospital Center New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Sentara Cardiovascular Research Institute Norfolk Virginia
United States Midwest Heart Foundation Oakbrook Terrace Illinois
United States Central Florida Pulmonary Group, P.A. Orlando Florida
United States Orlando Heart Center Orlando Florida
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Temple University Philadelphia Pennsylvania
United States Thomas Jefferson University Philadelphia Pennsylvania
United States University of Pennsylvania Health System Philadelphia Pennsylvania
United States Arizona Pulmonary Specialists, LTD Phoenix Arizona
United States Pinehurst Medical Clinic Pinehurst North Carolina
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Legacy Pulmonary Northwest Portland Oregon
United States OHSU-Oregon Health and Science University Portland Oregon
United States Oregon Clinic, PC Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Mary M Parkes Center Rochester New York
United States Mayo Clinic Rochester Minnesota
United States University of California Davis Medical Center Sacramento California
United States Methodist Healthcare System of San Antonio San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States University of California, San Francisco San Francisco California
United States Paloma Medical Group San Juan Capistrano California
United States Santa Barbara Cottage Hospital Santa Barbara California
United States Stanford Hospital and Clinics Stanford California
United States Pulmonary Health Physicians Syracuse New York
United States William Beaumont Hospital Troy Michigan
United States Cleveland Clinic Florida Weston Florida
United States Western States Clinical Research, Inc. Wheat Ridge Colorado
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Berks Schuylkill Respiratory Specialists, Ltd. Wyomissing Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
United Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of Respiratory Tract-Related Adverse Events of Interest Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study. Follow-up every 3 months Yes
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