Double Blind Placebo Controlled Clinical investigation into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients with Severe Pulmonary Arterial Hypertension

Primary Outcomes: 6-minute walk distance, change from baseline to Week 12 Secondary Outcomes: NYHA Functional Classification, Borg Dyspnea scoring, Signs and symptoms of PAH, Quality of life – change from baseline to Week 12: Time to clinical worsening, first incidence of clinical worsening

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Inhaled Treprostinil Sodium	Phase II

Further Study Details: 

Primary Outcomes: 6-minute walk distance, change from baseline to Week 12
Secondary Outcomes: NYHA Functional Classification; Borg Dyspnea scoring; Signs and symptoms of PAH; Quality of life; Time to clinical worsening, first incidence of clinical worsening
Expected Total Enrollment:  150

Patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan for at least three months prior to study start will be randomized to either Treprostinil inhalation solution or matching placebo.

Administration of study medication will be performed by inhalation with the OPTINEB™ ultrasonic nebulizer.

The proposed dosing regimen will be four times daily—upon awakening, at midday, evening (dinnertime) and bedtime.

After a patient has completed the twelve-week study period, they will be given the option of enrolling into an open-label extension study.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

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, NYHA Class III or Class IV.

− Been on a stable dose of 125 mg twice daily (bid) of bosentan for at least three months prior to study start − An unencouraged six minute walk (6MWT) test of between 200 and 450 meters at screening − Cardiac catheterization within the past 13 months consistent with PAH, specifically PAPm ≥25 mmHg (at rest), PCWP (or left ventricular end diastolic pressure) ≤15 mmHg, and PVR >3 mmHg/L/min − Within the past 12 months patients must have had a chest radiograph consistent with the diagnosis of PAH − Be willing and able to follow all study procedures

Exclusion Criteria:

− Be considering pregnancy, be pregnant and/or lactating − PAH due to conditions other than noted in the above inclusion criteria. − Have had any change or discontinued any PAH medication within the last three months including but not limited to ETRA (endothelin receptor antagonist), or CCB calcium channel blockers (with the exception of anticoagulants) − Have received any prostanoid, or phosphodiesterase inhibitor (PDEI), within the 30 days before screening or be 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 be 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 a new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for PAH added within the last month, excepting anticoagulants − Have any musculoskeletal disease or any other disease that would limit ambulation.

Please refer to this study by ClinicalTrials.gov identifier  NCT00147199

Ted Staub      240-893-7072    ted@lungrx.com

Alabama
      UAB, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      Harbor-UCLA Medical Center, Torrance,  California,  90502,  United States; Not yet recruiting

Study chairs or principal investigators

Robert Roscigno, Ph.D.,  Principal Investigator,  Lung Rx, Inc.   

Study ID Numbers:  LRX-70362
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00147199
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13