TABLE 2

Pulmonary function test results

Cohort 1Cohort 2All
BLChange from BLBLChange from BLBLChange from BL
24 weeks48 weeks24 weeks48 weeks24 weeks48 weeks
FVC
 Subjects n534538363028897566
 FVC L
  Mean±se2.60±0.10−0.08±0.03−0.15±0.042.93±0.16−0.07±0.05−0.13±0.062.73±0.08−0.08±0.02−0.14±0.04
  Median (range)2.37 (1.50–4.22)−0.08 (−0.54–0.36)−0.17 (−0.68–0.57)2.62 (1.32–5.51)−0.08 (−0.37–0.82)−0.11 (−0.75–0.64)2.53 (1.32–5.51)−0.08 (−0.54–0.82)−0.14 (−0.75–0.64)
 FVC % predicted
  Mean±se62.8±1.80−1.80±0.65−3.00±1.0472.7±2.69−1.71±1.15−2.25±1.3466.8±1.56−1.77±0.60−2.69±0.82
  Median (range)63.2 (42.6–89.6)−1.54 (−15.7–6.8)−3.62 (−15.1–10.7)69.4 (52.9–111.7)−1.55 (−13.2–17.3)−1.89 (−16.7–14.1)65.9 (42.6–111.7)−1.54 (−15.7–17.3)−3.30 (−16.7–14.1)
DLCO % predicted, Hb corrected
 Subjects n534337362927897264
 Mean±se48.3±1.7−4.71±0.88−4.50±0.9649.7±2.4−2.01±0.99−5.61±1.0849.8±1.41−3.62±0.67−4.9±0.72
 Median (range)47.0 (31.1–94.5)−4.55 (−19.7–7.4)−3.50 (−19.0–11.6)49.5 (30.4–89.6)−3.24 (−11.1–10.1)−4.91 (−20.5–4.4)47.4 (30.4–94.5)−3.68 (−19.7–10.1)−4.71 (−20.5–11.6)
FEV1% predicted
 Subjects n534538363028897566
 Mean±se69.4±1.80−2.36±0.76−3.44±1.0879.7±2.54−1.43±1.33−1.65±1.3273.6±1.57−1.99±0.70−2.68±0.84
 Median (range)72.5 (47.5–103.0)−2.28 (−15.4–9.7)−3.65 (−17.0–10.8)77.9 (60.5–115.4)−2.36 (−19.2–19.4)−1.59 (−15.6–17.7)74.4 (47.5–115.4)−2.35 (−19.2–19.4)−2.16 (−17.0–17.7)
TLC % predicted
 Subjects n534337363028897365
 Mean±se65.2±1.6−1.55±1.21−2.89±1.2071.6±2.5−1.86±0.92−4.32±1.1667.8±1.41−1.68±0.80−3.51±0.84
 Median (range)64.3 (43.1– 98.9)−1.04 (−21.9– 13.8)−3.92 (−15.0– 17.9)68.9 (53.3– 118.5)−1.93 (−15.5– 9.7)−4.23 (−18.3– 8.9)65.3 (43.1– 118.5)−1.79 (−21.9– 13.8)−4.02 (−18.3– 17.9)
  • All data are from observed values. BL: baseline; FVC: forced vital capacity; DLCO: diffusing capacity of the lung for carbon dioxide; Hb: haemoglobin; FEV1: forced expiratory volume in 1s; TLC: total lung capacity.