Acute respiratory distress syndrome (ARDS) is a severe form of acute lung injury and a major
cause of Intensive Care Unit (ICU) admission worldwide. Despite a large number of randomized
clinical trials, a specific and effective pharmacological approach for patients with ARDS is
still lacking.
Fibroproliferation is a crucial part of the host defence response, and severe fibrotic lung
disease affects ARDS patients even years after acute phase resolution.
Pirfenidone is an oral anti-fibrotic drug, approved and largely used for treatment of
idiopathic pulmonary fibrosis (IPF). The effect of Pirfenidone in ARDS has been evaluated
only in animal models.
This is a randomized controlled study to evaluate for the first time the efficacy of
Pirfenidone in ARDS.