Design and rationale of a randomised, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis.
ERJ Open Res
; 7(2)2021 Apr.
Article
in En
| MEDLINE
| ID: mdl-34109243
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 21 ratio to receive pirfenidone 2403â
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.
Full text:
1
Collection:
01-internacional
Health context:
4_TD
/
6_ODS3_enfermedades_notrasmisibles
Database:
MEDLINE
Type of study:
Clinical_trials
Language:
En
Journal:
ERJ Open Res
Year:
2021
Document type:
Article