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

Location:

Jacksonville, Fla., Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

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.

Who is eligible to participate?

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

Last updated:
2/28/2014
NCT ID:
NCT01266265