Design and rationale of a randomised, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis

• Published in: ERJ open research 2021-04, Vol.7 (2), p.54
• Main 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
• Format: Article
• Language: English
• Subjects: Study Protocols
• ISSN: 2312-0541; 2312-0541
• DOI: 10.1183/23120541.00054-2021

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.