Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: Inhaled treprostinil; Placebo inhalation solution
Intervention description: Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.; Doses are titrated to 9 breaths four times daily.
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension

Summary:

      This is a double-blind placebo-controlled clinical investigation into the efficacy and
      tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension.
      The primary outcome is the change in 6-minute walk distance from baseline to week 12.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically stable, pulmonary arterial hypertension diagnosed as either idiopathic or
             familial PAH, collagen vascular disease associated PAH, HIV PAH, or PAH induced by
             anorexigens, New York Heart Association (NYHA) Class III or Class IV.

          -  Been on a stable dose of 125 mg twice daily (bid) of bosentan OR any stable dose of
             sildenafil for at least three months prior to study start

          -  An unencouraged six minute walk test (6MWT) of between 200 and 450 meters at screening

          -  Cardiac catheterization within the past 13 months consistent with PAH, specifically
             mean pulmonary artery pressure (PAPm) ≥25 mmHg (at rest), pulmonary capillary wedge
             pressure (PCWP) (or left ventricular end diastolic pressure) ≤15 mmHg, and pulmonary
             vascular resistance (PVR) >3 mmHg/L/min

          -  Within the past 12 months, patients must have had a chest radiograph consistent with
             the diagnosis of PAH

          -  Willing and able to follow all study procedures

        Exclusion Criteria:

          -  Considering pregnancy, are pregnant and/or lactating

          -  PAH due to conditions other than noted in the above inclusion criteria.

          -  Have had any change in or discontinued any PAH medication within the last three
             months, including but not limited to endothelin receptor antagonist (ERA), or calcium
             channel blockers (CCB) (with the exception of anticoagulants)

          -  Have received any prostanoid within the 30 days before screening or are scheduled to
             receive any during the course of the study

          -  Have received any investigational medication within 30 days prior to the start of this
             study or are scheduled to receive another investigational drug during the course of
             this study

          -  Have a known intolerance to any drug, especially to treprostinil sodium or prostanoids

          -  Have an increased risk of hemorrhage

          -  Have a new type of chronic therapy (e.g., a different category of vasodilator,
             diuretic) for PAH added within the last month, except anticoagulants

          -  Have any musculoskeletal disease or any other disease that would limit ambulation.