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
• 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

• Hypertension
• Pulmonary Arterial Hypertension

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