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Double-blind, placebo-controlled trial of pirfenidone in patients with idiopathic pulmonary fibrosis.

Abstract
Idiopathic pulmonary fibrosis (IPF) is a fatal disorder without an effective therapy to date. In a double-blind, randomized, placebo-controlled trial, 107 patients were prospectively evaluated for efficacy of a novel compound, pirfenidone. The difference in the change in the lowest oxygen saturation by pulse oximetry (SpO2) during a 6-minute exercise test, the primary endpoint, from baseline to 6 months was not significant between the two groups (p = 0.0722). In a prespecified subset of patients who maintained a SpO2 greater than 80% during a 6-minute exercise test at baseline, the lowest SpO2 improved during a 6-minute exercise test in the pirfenidone group at 6 and 9 months (p = 0.0069 and 0.0305, respectively). Positive treatment effect was demonstrated in secondary endpoints: (1) change in VC measurements at 9 months (p = 0.0366) and (2) episodes of acute exacerbation of IPF occurring exclusively in the placebo group during the 9 months (p = 0.0031). Significant adverse events were associated with pirfenidone; however, adherence to treatment regimen was similar between pirfenidone and placebo groups. In conclusion, treatment with pirfenidone improved VC and prevented acute exacerbation of IPF during the 9 months of follow-up. Future long-term studies are needed to clarify the overall safety and efficacy of pirfenidone in IPF.
AuthorsArata Azuma, Toshihiro Nukiwa, Eiyasu Tsuboi, Moritaka Suga, Shosaku Abe, Koichiro Nakata, Yoshio Taguchi, Sonoko Nagai, Harumi Itoh, Motoharu Ohi, Atsuhiko Sato, Shoji Kudoh
JournalAmerican journal of respiratory and critical care medicine (Am J Respir Crit Care Med) Vol. 171 Issue 9 Pg. 1040-7 (May 01 2005) ISSN: 1073-449X [Print] United States
PMID15665326 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Pyridones
  • pirfenidone
Topics
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
  • Double-Blind Method
  • Exercise (physiology)
  • Exercise Test
  • Female
  • Humans
  • Male
  • Middle Aged
  • Oxygen Consumption
  • Prospective Studies
  • Pulmonary Fibrosis (drug therapy, physiopathology)
  • Pyridones (adverse effects, therapeutic use)
  • Total Lung Capacity
  • Vital Capacity

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