Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects

United Therapeutics

Status and phase: Completed; Phase 4

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Inhaled treprostinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00741819

RIN-PH-401

Details and patient eligibility

About

This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis).

Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.

Enrollment: 73 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between 18 and 75 years of age
• PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired >/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
• Baseline six-minute walk distance (6MWD) >/= 250 meters
• Currently receiving Ventavis and be stable at current dose for 30 days prior to Baseline
• If currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to Baseline
• Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH

Exclusion criteria

• Nursing or pregnant
• Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
• History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
• Use of investigational drug within 30 days of Baseline

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Inhaled treprostinil

Experimental group

Description:

Solution for oral inhalation treprostinil (0.6 mg/mL). Inhaled via an ultrasonic nebulizer which provides a dose of 6mcg of treprostinil per breath. Doses are titrated up to 12 breaths four times daily.

Treatment:

Drug: Inhaled treprostinil