Table 1

Characteristics of study participants

Studies includedCountrySample size (P/C)Age (mean±SD, years)Males (%, P/C)Study period (weeks)InterventionPrimary outcome
PirfenidoneControlsPirfenidoneControls
Azuma et al, 200522Western72/3564.0±7.164.3±7.662 (86.1%)/33 (94.3%)36Pirfenidone 1800 mg/dayPlacebo pillsChange in the lowest SpO2 during 6MWT
Taniguchi et al, 201023Asian108/55/104*65.4±6.2/63.9±7.5*64.7±7.385 (78.7%)/47 (85.4%)/81 (77.9%)*52Pirfenidone 1800 or 1200 mg/day*Placebo pillsChange from baseline to week 52 in predicted FVC
Noble et al, 2011 (PIPF 004)12Western174/87/174*65.7±8.2/68.0±7.6*66.3±7.5118 (67.8%)/65 (74.7%)/128 (73.6%)*72Pirfenidone 2403 or 1197 mg/day*Placebo pillsChange from baseline to week 72 in predicted FVC
Noble et al, 2011 (PIPF 006)12Western171/17766.8±7.967.0±7.8123 (71.9%)/124 (70.1%)52Pirfenidone 2403 mg/dayPlacebo pillsChange from baseline to week 72 in predicted FVC
Kind et al 201424Western278/27768.4±6.767.8±7.3222 (80.0%)/213 (76.9%)48Pirfenidone 2403 mg/dayPlacebo pillsChange from baseline to week 52 in predicted FVC
Huang et al, 201511Asian38/3859.0±5.961.6±6.433 (86.8%)/38 (100.0%)48Pirfenidone 1800 mg/dayPlacebo pillsChange from baseline to week 48 in predicted FVC
Furuya et al, 201721Asian20/2776 (66–82)73 (64–84)18 (90.0%)/24 (88.9%)52Pirfenidone 1200–1800 mg/dayPlacebo pills3 month survival and adverse events
Nathan et al, 201914Western90/8070 (46–80)69 (40–80)†74 (82.2%)/59 (73.8%)52Pirfenidone 1800 mg/dayPlacebo pillsChange from baseline to week 52 in predicted FVC
Vianello et al, 201925Western11/962 (52–78)74 (50–87)†9 (81.8%)/6 (66.7%)52Pirfenidone 2403 mg/dayPlacebo pillsChange from baseline to week 52 in predicted FVC
  • *Data for two trial groups and one control group.

  • †Range of age.

  • C, control group; FVC, forced vital capacity; 6MWT, 6 min walk test; NA, not available; P, pirfenidone group.