The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
344
Oral inhalation using a capsule-based dry powder.
Oral inhalation in initial double-dummy titration period.
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 108 weeks
Change From Baseline in 6-Minute Walk Distance (6MWD) Measured Post-Dose
Time frame: Up to 104 weeks
Absolute Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Up to 104 weeks
Percent Change From Baseline in Forced Vital Capacity (FVC)
Time frame: Up to 104 weeks
Absolute Change From Baseline in Percent Predicted FVC (FVC% pred)
Time frame: Up to 104 weeks
Percent Change From Baseline in Percent Predicted FVC (FVC% pred)
Time frame: Up to 104 weeks
Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Up to 104 weeks
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Up to 104 weeks
Absolute Change From Baseline in Percent Predicted FEV1 (FEV1%)
Time frame: Up to 104 weeks
Percent Change From Baseline in Percent Predicted FEV1 (FEV1%)
Time frame: Up to 104 weeks
Change From Baseline in the Plasma Concentration of N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP)
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Time frame: Up to 104 weeks
Annualized Rate of Occurrence of Exacerbations of Interstitial Lung Disease (ILD)
Time frame: Up to 104 weeks
Percentage of Participants With a Clinical Worsening Events
Time frame: Up to 104 weeks
Mean Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in L-PF Cough Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in L-PF Dyspnea Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in L-PF Impact Domain Score
Time frame: Up to 104 weeks
Mean Change From Baseline in the EuroQoL- 5 Dimensions (EQ-5D-5L) Index Score
Time frame: Up to 104 weeks
Mean Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS)
Time frame: Up to 104 weeks
Percentage of Participants With Major Morbidity or Mortality Events
Time frame: Up to 104 weeks