6/28/23, 12:45 AM ASCEND (pirfenidone) Pathway Feedback Search Clinical Topics Home Studies ASCEND (pirfenidone) ASCEND (pirfenidone) Disease Idiopathic pulmonary fibrosis Trial question What is the role of pirfenidone in patients with idiopathic pulmonary fibrosis? Study design Multi-center Open label RCT Population Characteristics of study participants 22.0% female N = 555 78.0% male 555 patients (120 female, 435 male) Inclusion criteria: patients with idiopathic pulmonary fibrosis Key exclusion criteria: history of malignancy, severe hepatic impairment, end-stage renal disease, unstable deteriorating cardiac or pulmonary disease, pregnancy or lactation, or history of alcohol or substance abuse in the past 2 years Interventions N=278 pirfenidone (2403 mg PO per day for 52 weeks) N=277 placebo (matching placebo PO for 52 weeks) Primary outcome Death or a 10% decline in forced vital capacity at 52 weeks https://web.pathway.md/studies/recuVcgroYmfYZNQj 1/2 6/28/23, 12:45 AM ASCEND (pirfenidone) Pathway 31.8 % 31.8 23.9 % 16.5 15.9 % Significant decrease 8.0 % NNT = 7 0.0 % Pirfenidone Placebo Significant decrease in death or a 10% decline in FVC at 52 weeks (16.5% vs. 31.8%; RR 0.52, 95% CI 0.21 to 0.83) Secondary outcomes Significant decrease in change in 6-minute walk distance or death at 52 weeks (25.9% vs. 35.7%; RR 0.73, 95% CI 0.03 to 1.43) No significant difference in death from any cause (4% vs. 7.2%; HR 0.55, 95% CI 0.26 to 1.15) Safety outcomes Significant difference in grade 3 GI adverse events (5.4% vs. 1.4%) and grade 3 skin-related adverse events (1.8% vs. 0.4%). Conclusion In patients with idiopathic pulmonary fibrosis, pirfenidone was superior to placebo with respect to death or a 10% decline in FVC at 52 weeks. Reference King TE Jr, Bradford WZ, Castro-Bernardini S et al. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. Open reference URL https://web.pathway.md/studies/recuVcgroYmfYZNQj 2/2