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

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ClinicalTrials.gov Identifier: NCT00705133
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
United Therapeutics
Information provided by (Responsible Party):
Rajan Saggar, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Drug: Treprostinil Phase 2

Detailed Description:
Patients with pulmonary hypertension 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease
Actual Study Start Date : July 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : April 2011


Arm Intervention/treatment
Experimental: Treprostinil-treated
Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion
Drug: 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
Other Name: remodulin




Primary Outcome Measures :
  1. 6 minute walk distance [ Time Frame: 3 months ]
    ATS Practice Guideline based 6MW distance


Secondary Outcome Measures :
  1. pulmonary hemodynamics [ Time Frame: 3 months ]
    repeat right heart catheterization

  2. Quality of life and shortness of breath indices [ Time Frame: 3 months ]
    SF-36 and SGRQ

  3. brain natriuretic peptide [ Time Frame: 3 months ]
    BNP



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Eligible subjects must have IPF and severe 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705133


Locations
United States, California
David Geffen School of Medicine, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Rajan Saggar
United Therapeutics
Investigators
Principal Investigator: Rajan Saggar, MD David Geffen School of Medicine, UCLA
Principal Investigator: David Zisman, MD David Geffen School of Medicine, UCLA

Publications of Results:
Responsible Party: Rajan Saggar, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00705133     History of Changes
Other Study ID Numbers: 07-11-087-01
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rajan Saggar, University of California, Los Angeles:
pulmonary hypertension
pulmonary fibrosis
interstitial lung disease

Additional relevant MeSH terms:
Hypertension
Fibrosis
Lung Diseases
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Respiratory Tract Diseases
Treprostinil
Antihypertensive Agents