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)

Conditions

Progressive Pulmonary Fibrosis

Brief summary

Change in absolute FVC from baseline to Week 52.

Detailed description

Time to first clinical worsening event (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC), Time to first acute exacerbation of ILD, Overall survival at Week 52, Change from baseline in % predicted FVC at Week 52, Change from baseline in K-BILD score at Week 52, Change from baseline in DLCO at Week 52, Change from baseline in absolute FVC at Weeks 16, 28, and 40, Change from baseline in NT-proBNP at Week 52, Change from baseline in resting supplemental oxygen use at Week 52, Adverse events (AEs) and serious adverse events (SAEs), Clinical laboratory parameters, Vital signs, including saturation of peripheral capillary oxygenation (SpO2), 12-Lead electrocardiograms

Related papers

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Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGThe Placebo Nebuliser Solution is a solution dosage form for nebulisation identical to Treprostinil Nebuliser Solution drug product except for the absence of the treprostinil drug substance.

DRUGTreprostinil

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Time to first clinical worsening event (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC), Time to first acute exacerbation of ILD, Overall survival at Week 52, Change from baseline in % predicted FVC at Week 52, Change from baseline in K-BILD score at Week 52, Change from baseline in DLCO at Week 52, Change from baseline in absolute FVC at Weeks 16, 28, and 40, Change from baseline in NT-proBNP at Week 52, Change from baseline in resting supplemental oxygen use at Week 52, Adverse events (AEs) and serious adverse events (SAEs), Clinical laboratory parameters, Vital signs, including saturation of peripheral capillary oxygenation (SpO2), 12-Lead electrocardiograms	—

Measure

Time frame

Time to first clinical worsening event (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC), Time to first acute exacerbation of ILD, Overall survival at Week 52, Change from baseline in % predicted FVC at Week 52, Change from baseline in K-BILD score at Week 52, Change from baseline in DLCO at Week 52, Change from baseline in absolute FVC at Weeks 16, 28, and 40, Change from baseline in NT-proBNP at Week 52, Change from baseline in resting supplemental oxygen use at Week 52, Adverse events (AEs) and serious adverse events (SAEs), Clinical laboratory parameters, Vital signs, including saturation of peripheral capillary oxygenation (SpO2), 12-Lead electrocardiograms

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Primary

Measure	Time frame
Change in absolute FVC from baseline to Week 52.	—

Countries

Belgium, France, Germany, Italy, Spain

Outcome results

None listed