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

United Therapeutics1,333 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,333

Conditions

Pulmonary Arterial Hypertension

Interventions

inhaled prostacyclinDRUG

Tyvaso

inhaled prostacyclinDRUG

As prescribed by the physician

prostacyclinDRUG

As prescribed by the physician

subcutaneous and intravenous prostacyclin

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (88)

Outcomes

Primary Outcomes

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.

Time frame: Follow-up every 3 months

Data from ClinicalTrials.gov

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Cardiovascular Associates, P.C.

Birmingham, Alabama, United States

The University of Alabama at Birmingham

Birmingham, Alabama, United States

University of South Alabama

Mobile, Alabama, United States

Arizona Pulmonary Specialists, LTD

Phoenix, Arizona, United States

Berkeley Cardiovascular Medical Group

Berkeley, California, United States

Cedars-Sinai Heart Institute

Beverly Hills, California, United States

University California San Francisco

Fresno, California, United States

University of Southern California

Los Angeles, California, United States

West Los Angeles VA Healthcare Center

Los Angeles, California, United States

University of California Davis Medical Center

Sacramento, California, United States

...and 78 more locations