Phase 2
N=15
Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension · Interstitial Lung Disease · Idiopathic Pulmonary Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00705133 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: 6 Minute Walk Distance — 230 meters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Treprostinil (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Rajan Saggar
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minute Walk Distance |
230 | — |
| SECONDARY Pulmonary Vascular Resistance |
496 | — |
| SECONDARY SF-36 Quality of Life |
28 | — |
| SECONDARY Brain Natriuretic Peptide |
228 | — |
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.
Eligibility Criteria
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.
- 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).
- 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) 120% predicted
- Standard of care high-resolution chest computed tomography (HRCT) showing emphysema extent > 30%
- Any investigational therapy as part of a clinical trial for any indication with 30 days before screening
- 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.
- Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
- 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
- Pulmonary rehabilitation initiated within 30 days of baseline.
Data sourced from ClinicalTrials.gov (NCT00705133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.