Pirfenidone for Idiopathic Pulmonary Fibrosis and Beyond.

As in the previous study, PFD was well tolerated.[ 35 ] In 2005 a double-blind, placebo-controlled, randomised, phase II trial tested the efficacy of PFD at a maximum dose of 1,800 mg/day in 107 patients with IPF.[ 36 ] The primary endpoint – the change in the lowest oxygen desaturation (SpO 2 ) during a 6-minute walking test (6MWT) – did not reach statistical significance (p=0.072), but PFD treatment demonstrated its efficacy in a few secondary endpoints, showing a significantly smaller decline in vital capacity (VC) (p=0.037) and preventing acute exacerbation of IPF at 9 months (p=0.003).

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