TABLE 2

Changes in clinical characteristics over 12 months

3 monthsp-value6 monthsp-value9 monthsp-value12 monthsp-value
Lung function
 ΔFEV1 mL−33.2±166.9
(−91.5 to 25.0)
0.25−96.5±197.7
(−169.0 to −23.9)
0.01
 ΔFEV1 %−0.7±5.7
(−2.7 to 1.3)
0.45−2.4±6.5
(−4.8 to 0.0)
0.05
 ΔFVC mL−125.9±330.4
(−241.2 to −10.6)
0.03−191.3±483.7
(−368.7 to −13.9)
0.04
 ΔFVC %−3.1±9.5
(−6.4 to 0.2)
0.06−2.8±13.0
(−7.6 to 2.0)
0.24
 ΔFEV1/FVC %0.3±10.6
(−3.5 to 4.0)
0.89−0.9±3.6
(−2.2 to 0.4)
0.18
 ΔFIV1 mL−175.8±389.5
(−340.3 to −11.4)
0.04−66.2±371.1
(−235.1 to 102.7)
0.42
 ΔVC L1.2±6.6
(−1.4 to 3.9)
0.35−0.1±0.4
(−0.3 to 0.1)
0.49
 ΔRaw kPa·s·L−10.1±0.3
(−0.1 to 0.2)
0.280.0±0.2
(−0.1 to 0.2)
0.33
Exercise capacity
 Δ6MWD m1.1±55.4
(−18.6 to 20.7)
0.9120.3±72.0
(−6.6 to 47.2)
0.1324.3±65.0
(−0.4 to 49.0)
0.058.5±76.2
(−19.4 to 36.5)
0.54
Symptoms
 ΔmMRC0 (IQR −1 to 0)0.290 (IQR −1 to 0)0.100 (IQR −1 to 0)0.160 (IQR −1 to 0)0.30
 ΔCAT#−3.8±7.1
(−6.4 to −1.3)
<0.01−3.4±6.8
(−5.9 to −0.9)
0.01−0.9±7.7
(−3.8 to 2.0)
0.53−2.0±7.2
(−4.7 to 0.6)
0.12
 ΔSGRQ total
  score
−6.4±14.4
(−11.4 to −1.3)
0.01−9.5±15.7
(−15.4 to −3.6)
<0.01−6.9±16.2
(−13.0 to −0.9)
0.03−4.6±15.1
(−10.2 to 0.9)
0.10
 ΔSGRQ symptoms−6.3±22.1
(−14.0 to 1.4)
0.10−8.8±19.6
(−16.1 to −1.4)
0.02−4.9±21.9
(−13.1 to 3.3)
0.23−4.3±21.5
(−12.2 to 3.5)
0.27
 ΔSGRQ activity−2.5±15.0
(−7.7 to 2.7)
0.34−4.4±17.5
(−11.0 to 2.1)
0.17−2.6±17.9
(−9.3 to 4.1)
0.43−2.5±14.8
(−7.9 to 3.0)
0.36
 ΔSGRQ impacts−8.7±16.7
(−14.5 to −2.9)
<0.01−12.9±17.9
(−19.6 to −6.2)
<0.01−10.2±18.4
(−17.1 to −3.4)
<0.01−6.1±20.0
(−13.4 to 1.3)
0.10
 ΔLCQ21.6±32.2
(7.3 to 35.9)
<0.0121.6±29.2
(8.3 to 34.9)
<0.0113.4±24.1
(2.1 to 24.6)
0.029.1±29.0
(−4.1 to 22.3)
0.17
 ΔVAS rest#−3.6±31.5
(−14.8 to 7.5)
0.51−2.7±25.5
(−12.2 to 6.9)
0.57−1.1±31.1
(−12.8 to 10.5)
0.85−0.4±25.4
(−9.7 to 8.9)
0.93
 ΔVAS activity#−7.2±22.2
(−15.0 to 0.7)
0.07−10.3±22.4
(−18.7 to −1.9)
0.02−7.1±25.2
(−17.3 to 1.9)
0.13−6.7±21.4
(−14.6 to 1.2)
0.09
Mortality score
 ΔBODE index−0.1±1.1
(−0.5 to 0.3)
0.540.1±1.4
(−0.4 to 0.6)
0.61
Inflammatory marker
 ΔFibrinogen mg·dL−145.2±84.5
(15.2 to 75.1)
<0.0129.3±65.2
(4.5 to 54.1)
0.02

Data are presented as mean±sd (95% CI), unless otherwise stated. Bold type represents statistical significance. Two-tailed t-test used to calculate statistical significance between groups, unless otherwise stated. Δ: change; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; FIV1: forced inspiratory volume in 1 s; VC: vital capacity; Raw: airway resistance; 6MWD: 6-min walk distance; mMRC: modified Medical Research Council dyspnoea scale; CAT: COPD Assessment Test; SGRQ: St George's Respiratory Questionnaire; LCQ: Leicester Cough Questionnaire; VAS: visual analogue scale; BODE: body mass index, airflow obstruction, dyspnoea and exercise capacity; IQR: interquartile range. #: pre-treatment 1 data used; : Wilcoxon matched-pairs signed rank test used to calculate statistical significance between groups.