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

Completed

Interventions: Drug: inhaled prostacyclin
Drug: prostacyclin
Drug: subcutaneous and intravenous prostacyclin
Drug: oral ERA
Drug: oral PDE5 inhibitors

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Tyvaso	inhaled prostacyclin	The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
Control	inhaled prostacyclin	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.
Control	subcutaneous and intravenous prostacyclin	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.
Control	oral ERA	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.
Control	oral PDE5 inhibitors	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.
Control	prostacyclin	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of Respiratory Tract-Related Adverse Events of Interest	Follow-up every 3 months	Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.

Secondary Outcome Measures

Name	Time	Method

Locations (88): Cardiovascular Associates, P.C.
🇺🇸
Birmingham, Alabama, United States
The University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
University of South Alabama
🇺🇸
Mobile, Alabama, United States
Arizona Pulmonary Specialists, LTD
🇺🇸
Phoenix, Arizona, United States
Berkeley Cardiovascular Medical Group
🇺🇸
Berkeley, California, United States
Cedars-Sinai Heart Institute
🇺🇸
Beverly Hills, California, United States
University California San Francisco
🇺🇸
Fresno, California, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
West Los Angeles VA Healthcare Center
🇺🇸
Los Angeles, California, United States
University of California Davis Medical Center
🇺🇸
Sacramento, California, United States
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Cardiovascular Associates, P.C.
🇺🇸Birmingham, Alabama, United States