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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics
• Treatments: Ambrisentan; Bosentan; Epoprostenol; Iloprost; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Tezosentan; Treprostinil

Criteria

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