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

United Therapeutics

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: oral ERA; Drug: inhaled prostacyclin; Drug: prostacyclin; Drug: subcutaneous and intravenous prostacyclin; Drug: oral PDE5 inhibitors

Study type: Observational

Funder types: Industry

Identifiers

NCT01266265

RIN-PH-403

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,333 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,333 participants in 2 patient groups

Tyvaso

Description:

The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.

Treatment:

Drug: inhaled prostacyclin

Drug: inhaled prostacyclin

Control

Description:

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.

Treatment:

Drug: inhaled prostacyclin

Drug: oral PDE5 inhibitors

Drug: subcutaneous and intravenous prostacyclin

Drug: prostacyclin

Drug: oral ERA

Drug: inhaled prostacyclin