The primary objective of this study is to evaluate the effect of 52 weeks of once daily treatment with TPIP compared with placebo on lung function in adults with PPF.
Radiologic evidence of pulmonary fibrosis of >10% extent on high-resolution computed tomography (HRCT) in the previous 12 months.
Clinically significant decline in % predicted Forced Vital Capacity (FVC) based on ≥10% relative decline
Decline in % predicted FVC based on ≥5% to <10% relative decline combined with worsening of respiratory symptoms
Decline in % predicted FVC based on ≥5% to <10% relative decline combined with an increasing extent of fibrotic changes on chest imaging
Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) <0.7 and less than the age-adjusted lower limit of normal at Screening.
Diagnosis of idiopathic pulmonary fibrosis (IPF).
Diagnosis of combined pulmonary fibrosis and emphysema.
Extent of emphysema greater than fibrosis on HRCT within 1 year prior to Screening or during the screening period confirmed by central overread.
Parallel
Treprostinil Palmitil Inhalation Powder
DrugOral inhalation using a capsule-based dry powder inhaler device.
Placebo
DrugOral inhalation using a capsule-based dry powder inhaler device.
Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52
Time to First Clinical Worsening Event
Time to First Acute Exacerbation of Interstitial Lung Disease (ILD)
Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % Predicted Corrected for Hemoglobin at Week 52
Time to Death
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