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

NCT01266265 | Completed Results

• 1 other identifier: RIN-PH-403
• Study Type: observational
• Target: 1,333
• Locations: 1 country
• Sites: 88

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Control

The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.

Drug: inhaled prostacyclin; Drug: prostacyclin; Drug: subcutaneous and intravenous prostacyclin; Drug: oral ERA; Drug: oral PDE5 inhibitors

Interventions

inhaled prostacyclin DRUG

Tyvaso

Also known as: treprostinil

Tyvaso

prostacyclin DRUG

As prescribed by the physician

Also known as: epoprostenol sodium, Flolan

Control

subcutaneous and intravenous prostacyclin DRUG

As prescribed by physician

Also known as: treprostinil , Remodulin

Control

oral ERA DRUG

As prescribed by physician

Also known as: bosentan, Tracleer, ambrisentan, Letairis

Control

oral PDE5 inhibitors DRUG

As prescribed by physician

Also known as: sildenafil, Revatio, tadalafil, Adcirca

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community centers, academic institutions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United Therapeutics: lead

Study Sites (88)

Cardiovascular Associates, P.C.

Birmingham, Alabama, 35213, United States

Location

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of South Alabama

Mobile, Alabama, 36693, United States

Location

Arizona Pulmonary Specialists, LTD

Phoenix, Arizona, 85013, United States

Location

Berkeley Cardiovascular Medical Group

Berkeley, California, 94705, United States

Location

Cedars-Sinai Heart Institute

Beverly Hills, California, 90211, United States

Location

University California San Francisco

Fresno, California, 93721, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

West Los Angeles VA Healthcare Center

Los Angeles, California, 90073, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Paloma Medical Group

San Juan Capistrano, California, 92675, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Children's Hospital Denver

Denver, Colorado, 80045, United States

Location

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, 80033, United States

Location

St. Francis Sleep Allergy & Lung

Clearwater, Florida, 33765, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Pulmonary and Critical Care Associates

Jacksonville, Florida, 32204, United States

Location

University of Florida College of Medicine Jacksonville

Jacksonville, Florida, 32209, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Miami Center for Cardiovascular Disease

Miami, Florida, 33136, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Central Florida Pulmonary Group, P.A.

Orlando, Florida, 32806, United States

Location

Orlando Heart Center

Orlando, Florida, 32806, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Georgia Lung Associates, PC

Austell, Georgia, 30106, United States

Location

Northwestern Medical Center

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Midwest Heart Foundation

Oakbrook Terrace, Illinois, 60181, United States

Location

Indiana University Hospital

Carmel, Indiana, 46032, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Mercy Hospital

Iowa City, Iowa, 52245, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Tufts - New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Nebraska Pulmonary Specialties, LLC

Lincoln, Nebraska, 68506, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

SUNY Stony Brook University Medical Center

Islandia, New York, 11790, United States

Location

Winthrop Pulmonary Associates

Mineola, New York, 11501, United States

Location

North Shore - Long Island Jewish Health System

New Hyde Park, New York, 11040, United States

Location

St. Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mary M Parkes Center

Rochester, New York, 14623, United States

Location

Pulmonary Health Physicians

Syracuse, New York, 13210, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Pinehurst Medical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Akron General Hospital

Akron, Ohio, 44302, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0564, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Davis Heart and Lung Research Institute

Columbus, Ohio, 43210, United States

Location

Mercy Fairfield Hospital

Fairfield, Ohio, 45014, United States

Location

Legacy Pulmonary Northwest

Portland, Oregon, 97210, United States

Location

Oregon Clinic, PC

Portland, Oregon, 97220, United States

Location

OHSU-Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Berks Schuylkill Respiratory Specialists, Ltd.

Wyomissing, Pennsylvania, 19610, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Lexington Pulmonary and Critical Care

Lexington, South Carolina, 29072, United States

Location

MD Total Care, PLLC

Chattanooga, Tennessee, 37419, United States

Location

Summit Medical Group

Knoxville, Tennessee, 37909, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• 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.

  PMID: 27683610 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Respiratory Aspiration

Interventions

treprostinil; Iloprost; Epoprostenol; Injections, Subcutaneous; Bosentan; ambrisentan; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins I; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Piperazines; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbolines; Pyridines; Indole Alkaloids; Indoles; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Nicole Leedom
• Organization: United Therapeutics Corporation

nleedom@unither.com

919-425-5870

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 24, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 17, 2016
• Results First Posted: February 17, 2016

Record last verified: 2016-01

Locations

US (88)