6/28/23, 11:35 PM INPULSIS Pathway Feedback Search Clinical Topics Home Studies INPULSIS INPULSIS Disease Idiopathic pulmonary fibrosis Trial question What is the effect of nintedanib in patients with idiopathic pulmonary fibrosis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 21.0% female N = 1066 79.0% male 1066 patients (220 female, 841 male) Inclusion criteria: patients with idiopathic pulmonary fibrosis Key exclusion criteria: liver transaminases or bilirubin above 1.5-fold ULN, myocardial infarction within 6 months or unstable angina within 1 month of randomization, taking full-dose anticoagulant therapy or high-dose antiplatelet therapy at screening, or treatment with NAC or prednisone > 15 mg/day or equivalent within 2 weeks of screening Interventions N=638 nintedanib (150 mg BID for 52 weeks) N=423 placebo (matching placebo for 52 weeks) Primary outcome Significant increase in the incidence of decline in FVC, in INPULSIS-1 (-114.7 mL/year vs. -239.9 mL/year; AD 125.3 mL/year, 95% CI 77.7 to 172.8) t https://web.pathway.md/studies/reccMJuaoyLd2h3t2 S d 1/2 6/28/23, 11:35 PM INPULSIS Pathway Secondary outcomes Significant increase in the incidence of change in FVC, in INPULSIS-2 (-113.6 mL/year vs. 207.3 mL/year; AD 93.7 mL/year, 95% CI 44.8 to 142.7) Safety outcomes Significant difference in adverse event related to diarrhea in INPULSIS-1 (61.5% vs. 18.6%) and INPULSIS-2 (63.2% vs. 18.3%). Conclusion In patients with idiopathic pulmonary fibrosis, nintedanib was superior to placebo with respect to the incidence of decline in FVC, in INPULSIS-1. Reference Richeldi L, du Bois RM, Raghu G et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. Open reference URL https://web.pathway.md/studies/reccMJuaoyLd2h3t2 2/2