Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis: Results of two 52-week, Phase III, randomized, placebo-controlled trials (INPULSIS™)
U Costabel, L Richeldi, RM du Bois, G Raghu, A Azuma, KK Brown, V Cottin, KR Flaherty, Y Inoue, DS Kim, M Kolb, PW Noble, M Selman, H Taniguchi, M Brun, M Girard, R Schlenker-Herceg, B Disse, HR Collard · Pneumologie · 2015 · Heft 02
Bibliografische Angaben
Zusammenfassung
Background: Nintedanib (formerly known as BIBF 1120) is an intracellular inhibitor that targets multiple tyrosine kinases. Methods: We conducted two replicate 52-week, randomized, double-blind, phase 3 trials (INPULSIS-1 [NCT01335464] and INPULSIS-2 [NCT01335477]) to evaluate the efficacy and safety of 150 mg of nintedanib twice daily as compared with placebo in patients with idiopathic pulmonary fibrosis (IPF). The primary end point was the annual rate of decline in forced vital capacity (FVC). Key secondary end points were the time to the first acute exacerbation and the change from baseline in the total score…
