Fernández Pérez Evans R, Crooks James L, Swigris Jeffrey J, Solomon Joshua J, Mohning Michael P, Huie Tristan J, Koslow Matthew, Lynch David A, Groshong Steve D, Fier Kaitlin
Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, CO, USA.
Division of Biostatistics and Bioinformatics, National Jewish Health, Denver, CO, USA.
ERJ Open Res. 2021 Jun 7;7(2). doi: 10.1183/23120541.00054-2021. eCollection 2021 Apr.
Hypersensitivity pneumonitis (HP) is an immunologically mediated form of lung disease resulting from inhalational exposure to any of a large variety of antigens. A subgroup of patients with HP develops pulmonary fibrosis (fibrotic HP; FHP), a significant cause of morbidity and mortality. This study will evaluate the safety and efficacy of the antifibrotic pirfenidone in treating FHP. This single-centre, randomised, double-blind, placebo-controlled trial is enrolling adults with FHP (ClinicalTrials.gov: NCT02958917). Study participants must have fibrotic abnormalities involving ≥5% of the lung parenchyma on high-resolution computed tomography scan, forced vital capacity (FVC) ≥40% and diffusing capacity of the lung for carbon monoxide ≥30% of predicted values. Study participants will be randomised in a 2:1 ratio to receive pirfenidone 2403 mg·day or placebo. The primary efficacy end-point is the mean change in FVC % predicted from baseline to week 52. A number of secondary end-points have been chosen to evaluate the safety and efficacy in different domains.
过敏性肺炎（HP）是一种由吸入多种抗原中的任何一种所引发的免疫介导性肺部疾病。一部分HP患者会发展为肺纤维化（纤维化HP；FHP），这是发病和死亡的一个重要原因。本研究将评估抗纤维化药物吡非尼酮治疗FHP的安全性和有效性。这项单中心、随机、双盲、安慰剂对照试验正在招募患有FHP的成年人（ClinicalTrials.gov：NCT02958917）。研究参与者在高分辨率计算机断层扫描上必须有累及≥5%肺实质的纤维化异常，用力肺活量（FVC）≥40%，肺一氧化碳弥散量≥预测值的30%。研究参与者将按2:1的比例随机分组，分别接受2403毫克·天的吡非尼酮或安慰剂。主要疗效终点是从基线到第52周预测FVC%的平均变化。已选择了一些次要终点来评估不同领域的安全性和有效性。
