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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:December 2010
End Date:December 2014

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

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.

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
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