NCT01266265

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,333 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	inhaled prostacyclin	Tyvaso
DRUG	inhaled prostacyclin	As prescribed by the physician
DRUG	prostacyclin	As prescribed by the physician
DRUG	subcutaneous and intravenous prostacyclin	As prescribed by physician
DRUG	oral ERA	As prescribed by physician
DRUG	oral PDE5 inhibitors	As prescribed by physician

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-12-24
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

88 sites across 1 country: United States