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 |
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
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.
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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