Pooled analysis of data from the TOMORROW and INPULSIS® trials of nintedanib in IPF
C Neurohr, L Richeldi, V Cottin, M Selman, T Kimura, S Stowasser, KK Brown · Pneumologie · 2016 · Heft 02
Bibliografische Angaben
Zusammenfassung
Background: The 52-week, Phase II TOMORROW trial and two replicate 52-week, Phase III INPULSIS® trials investigated the efficacy and safety of nintedanib 150 mg twice daily (bid) versus placebo in patients with idiopathic pulmonary fibrosis (IPF). Aim: A pooled analysis of data from the TOMORROW and INPULSIS® trials was conducted to obtain a more precise estimate of the treatment effect of nintedanib. Methods: Results for annual rate of decline in forced vital capacity (FVC), time to first investigator-reported acute exacerbation, change from baseline in St George's Respiratory Questionnaire (SGRQ) total score a…