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Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
||A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
||Nicholas Hill, MD
The primary objective of the study is to evaluate the safety and efficacy of inhaled treprostinil in subjects with IPF. This study hypothesizes that inhaled treprostinil will have a positive effect on absolute FVC after 52 weeks of therapy as compared with placebo when administered to subjects with IPF. This is a Phase 3, randomized, double-blind, placebo-controlled, efficacy and safety study of subjects with IPF treated with inhaled treprostinil over a 52-week period.Approximately 396 eligible subjects study-wide will be randomly assigned 1:1 to inhaled treprostinil or placebo at Baseline. Randomization will be stratified by IPF background therapy (nintedanib or pirfenidone vs no background therapy). All subjects will initiate inhaled treprostinil (6 mcg/breath) or placebo at a dose of 3 breaths (18 mcg) administered QID (during waking hours) and will titrate to a target dosing regimen of 12 breaths (72 mcg) QID.
- Subject gives voluntary informed consent to participate in the study.
- Subject is ≥40 years of age, inclusive, at the time of signing informed consent.
- FVC ≥45% and ≤80% predicted at Screening.
- Subject is pregnant or lactating.
- Subject has primary obstructive airway physiology: FEV1/FVC <0.70 at Screening.
- The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
An HRCT (High Resolution Computed Tomography) scan will be performed at screening if there is no scan within 12 months. About 2-3 teaspoons of blood at each clinic visit will be collected for a total of about 21 teaspoons during the entire study for routine laboratory tests.