TETON-PPF

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)

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Pulmonary fibrosis
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All genders
person-wave 18-100
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Overview
Principal Investigator: Nicholas Hill, MD

This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, efficacy and safety study of subjects with Progressive Pulmonary Fibrosis (PPF) treated with inhaled treprostinil over a 52-week period

Study details
Inclusion Criteria
  • 1. More than 10% of pulmonary fibrosis on a High Resolution CT (HRCT) scan
  • 2. Progression of disease within past 2 years
  • 3. Forced Vital Capacity (FVC) of greater or equal to 45% in pulmonary function test.
Exclusion Criteria
  • 1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • 2. On oxygen therapy of more than 10 Liters/minute
  • 3. Active Respiratory Infection or exacerbation of interstitial lung disease in past 30 days.
Study Requirements

There will be at least 8 clinic visits over 52 weeks. Some visits may last up to 6 hours at the clinic with multiple tests (like CT scan, pulmonary function test). Blood sample taken will be between 1-2 tablespoons at each visit. An HRCT may be performed at screening if not done in past year.