Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-04-30

Brief Summary

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Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics and quality of life in patients with interstitial lung disease and severe secondary pulmonary arterial hypertension.

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Detailed Description

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Patients with pulmonary hypertension (PH) complicating pulmonary fibrosis are at increased risk of death. There are no therapies proven to be effective in this population, targeting the pulmonary hypertension. The purpose of this study is to evaluate parenteral treprostinil in an open-label fashion in patients with pulmonary fibrosis and an advanced PH phenotype.

Conditions

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Pulmonary Arterial Hypertension Interstitial Lung Disease Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treprostinil-treated

Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion

Group Type EXPERIMENTAL

Treprostinil

Intervention Type DRUG

For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated

Interventions

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Treprostinil

For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated

Intervention Type DRUG

Other Intervention Names

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remodulin

Eligibility Criteria

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Inclusion Criteria

Eligible subjects must have IPF and severe pulmonary arterial hypertension (PAH) documented on standard of care right-heart catheterization (RHC) and planned to receive therapy with treprostinil as recommended by the treating physician.

1. All subjects must have high resolution CT scan (HRCT) diagnostic of IPF (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (UIP).
2. Severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mPAP) \> 35 mm Hg; AND pulmonary vascular resistance (PVR) \> 3 woods-units; AND pulmonary capillary wedge pressure (PCWP) \< 18 mm Hg by right-heart catheterization (RHC) performed as part of standard of care evaluation.
3. All subjects must be planned to receive treprostinil therapy as recommended by their treating physician.

Exclusion Criteria

1. Acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6MWT).
2. Six-minute walk distance (6MWD) \< 50 meters at screening or baseline standard of care evaluations
3. Standard of care pulmonary function test (PFT) showing forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio \< 0.65
4. Standard of care pulmonary function test (PFT) showing a residual volume \>120% predicted
5. Standard of care high-resolution chest computed tomography (HRCT) showing emphysema extent \> 30%
6. Any investigational therapy as part of a clinical trial for any indication with 30 days before screening
7. Change in dose of treatment for IPF - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents, within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
8. Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
9. Change in dose of treatment for PAH - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
10. Pulmonary rehabilitation initiated within 30 days of baseline.

Eligible Sex

ALL

Accepts Healthy Volunteers

No