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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: inhaled prostacyclin
* Drug: inhaled prostacyclin
* Drug: prostacyclin
* Drug: subcutaneous and intravenous prostacyclin
* Drug: oral ERA
* Drug: oral PDE5 inhibitors


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tyvaso<br>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<br>* Tyvaso<br>* Other names: treprostinil;|
| Control<br>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<br>* As prescribed by the physician<br>* Other names: iloprost, Ventavis;Drug: prostacyclin<br>* As prescribed by the physician<br>* Other names: epoprostenol sodium, Flolan;Drug: subcutaneous and intravenous prostacyclin<br>* As prescribed by physician<br>* Other names: treprostinil , Remodulin;Drug: oral ERA<br>* As prescribed by physician<br>* Other names: ambrisentan, Letairis;Drug: oral PDE5 inhibitors<br>* As prescribed by physician<br>* Other names: tadalafil, Adcirca;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remodulin, pulmonary arterial hypertension, PAH, treprostinil sodium, Tyvaso, inhalation, Ventavis, iloprost, prostacyclin, epoprostenol sodium, Flolan, Veletri, subcutaneous and intravenous prostacyclin analogue, oral ERA, bosentan, Tracleer, ambrisentan, Letairis, oral PDE5 inhibitors, sildenafil, Revatio, tadalafil, Adcirca, Opsumit, macitentan, Adempas, riociguat, Orenitram, oral treprostinil