Design and rationale of a randomised, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis. Issue 2 (7th June 2021)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: ERJ open research. Volume 7:Issue 2(2021)
• Publication Date: 2021-06-07
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiration -- Periodicals; Respiration; Respiratory organs -- Diseases; Respiratory organs -- Diseases -- Treatment; Respiratory Tract Diseases; Electronic journals; Fulltext; Internet Resources; Periodicals; Periodical; 616.2005
• DOI: 10.1183/23120541.00054-2021
• Languages: English
• ISSNs: 2312-0541

Abstract

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 −1 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. The design of a phase II study of 52 weeks of pirfenidone or placebo on top of standard of care in patients with fibrotic HP (ClinicalTrials.gov NCT02958917) https://bit.ly/32CfeSF