Clinical trial NCT01266265: Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies
Official title: A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
PAH
treprostinil sodium
Tyvaso
inhalation
Ventavis
iloprost
prostacyclin
epoprostenol sodium
Flolan
Veletri
subcutaneous and intravenous prostacyclin analogue
Remodulin
oral ERA
bosentan
Tracleer
ambrisentan
Letairis
oral PDE5 inhibitors
sildenafil
Revatio
tadalafil
Adcirca
Opsumit
macitentan
Adempas
riociguat
Orenitram
oral treprostinil
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 1333
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community centers, academic institutions

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

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 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

Primary outcomes:
measure: Prevalence of Respiratory Tract-Related Adverse Events of Interest
timeFrame: Follow-up every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates, P.C.
state: Alabama
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, LTD
state: Arizona
city: Berkeley
country: United States
facility: Berkeley Cardiovascular Medical Group
state: California
city: Beverly Hills
country: United States
facility: Cedars-Sinai Heart Institute
state: California
city: Fresno
country: United States
facility: University California San Francisco
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: West Los Angeles VA Healthcare Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Juan Capistrano
country: United States
facility: Paloma Medical Group
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Denver
country: United States
facility: Children's Hospital Denver
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research, Inc.
state: Colorado
city: Clearwater
country: United States
facility: St. Francis Sleep Allergy & Lung
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Pulmonary and Critical Care Associates
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Miami Center for Cardiovascular Disease
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, P.A.
state: Florida
city: Orlando
country: United States
facility: Orlando Heart Center
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Austell
country: United States
facility: Georgia Lung Associates, PC
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Midwest Heart Foundation
state: Illinois
city: Carmel
country: United States
facility: Indiana University Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Iowa City
country: United States
facility: Mercy Hospital
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Lincoln
country: United States
facility: Nebraska Pulmonary Specialties, LLC
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Islandia
country: United States
facility: SUNY Stony Brook University Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop Pulmonary Associates
state: New York
city: New Hyde Park
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: St. Luke's-Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Mary M Parkes Center
state: New York
city: Syracuse
country: United States
facility: Pulmonary Health Physicians
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Akron
country: United States
facility: Akron General Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Davis Heart and Lung Research Institute
state: Ohio
city: Fairfield
country: United States
facility: Mercy Fairfield Hospital
state: Ohio
city: Portland
country: United States
facility: Legacy Pulmonary Northwest
state: Oregon
city: Portland
country: United States
facility: Oregon Clinic, PC
state: Oregon
city: Portland
country: United States
facility: OHSU-Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Schuylkill Respiratory Specialists, Ltd.
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Lexington
country: United States
facility: Lexington Pulmonary and Critical Care
state: South Carolina
city: Chattanooga
country: United States
facility: MD Total Care, PLLC
state: Tennessee
city: Knoxville
country: United States
facility: Summit Medical Group
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
References:
citation: Zamanian RT, Levine DJ, Bourge RC, De Souza SA, Rosenzweig EB, Alnuaimat H, Burger C, Mathai SC, Leedom N, DeAngelis K, Lim A, De Marco T. An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension. Pulm Circ. 2016 Sep;6(3):329-37. doi: 10.1086/688059.