An Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease

Conditions

Fibrotic Lung Disease

Brief summary

Efficacy will be assessed by evaluating the effect of continued long-term therapy with inhaled Treprostinil on the following parameters: 1. Change in absolute FVC, 2. Time to clinical worsening (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC), 3. Time to acute exacerbation of IPF or ILD, 4. Overall survival, 5. Change in % predicted FVC, 6. Change in K-BILD score, 7. Change in N-terminal pro-brain natriuretic peptide, 8. Change in DLCO, 9. Change in resting supplemental oxygen use, SAFETY ENDPOINTS Safety will be assessed by reviewing the following parameters: • AEs and serious adverse events (SAEs) • Clinical laboratory parameters •Vital signs, including resting saturation of peripheral capillary oxygenation (SpO2) • 12-lead electrocardiograms (ECGs)

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Interventions

DRUGTreprostinil

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Efficacy will be assessed by evaluating the effect of continued long-term therapy with inhaled Treprostinil on the following parameters: 1. Change in absolute FVC, 2. Time to clinical worsening (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC), 3. Time to acute exacerbation of IPF or ILD, 4. Overall survival, 5. Change in % predicted FVC, 6. Change in K-BILD score, 7. Change in N-terminal pro-brain natriuretic peptide, 8. Change in DLCO, 9. Change in resting supplemental oxygen use, SAFETY ENDPOINTS Safety will be assessed by reviewing the following parameters: • AEs and serious adverse events (SAEs) • Clinical laboratory parameters •Vital signs, including resting saturation of peripheral capillary oxygenation (SpO2) • 12-lead electrocardiograms (ECGs)	—

Measure

Time frame

Efficacy will be assessed by evaluating the effect of continued long-term therapy with inhaled Treprostinil on the following parameters: 1. Change in absolute FVC, 2. Time to clinical worsening (including time to death, respiratory hospitalization, or ≥10% relative decline in % predicted FVC), 3. Time to acute exacerbation of IPF or ILD, 4. Overall survival, 5. Change in % predicted FVC, 6. Change in K-BILD score, 7. Change in N-terminal pro-brain natriuretic peptide, 8. Change in DLCO, 9. Change in resting supplemental oxygen use, SAFETY ENDPOINTS Safety will be assessed by reviewing the following parameters: • AEs and serious adverse events (SAEs) • Clinical laboratory parameters •Vital signs, including resting saturation of peripheral capillary oxygenation (SpO2) • 12-lead electrocardiograms (ECGs)

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Countries

Belgium, Denmark, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed