TABLE 2.
Changes in clinical characteristics over 12 months
| 3 months | p-value | 6 months | p-value | 9 months | p-value | 12 months | p-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 L | 1.2±6.6 (−1.4 to 3.9) |
0.35 | −0.1±0.4 (−0.3 to 0.1) |
0.49 | ||||
| ΔRaw kPa·s·L−1 | 0.1±0.3 (−0.1 to 0.2) |
0.28 | 0.0±0.2 (−0.1 to 0.2) |
0.33 | ||||
| Exercise capacity | ||||||||
| Δ6MWD m | 1.1±55.4 (−18.6 to 20.7) |
0.91 | 20.3±72.0 (−6.6 to 47.2) |
0.13 | 24.3±65.0 (−0.4 to 49.0) |
0.05 | 8.5±76.2 (−19.4 to 36.5) |
0.54 |
| Symptoms | ||||||||
| ΔmMRC | 0 (IQR −1 to 0) | 0.29¶ | 0 (IQR −1 to 0) | 0.10¶ | 0 (IQR −1 to 0) | 0.16¶ | 0 (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 |
| ΔLCQ | 21.6±32.2 (7.3 to 35.9) |
<0.01 | 21.6±29.2 (8.3 to 34.9) |
<0.01 | 13.4±24.1 (2.1 to 24.6) |
0.02 | 9.1±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) |
0.54 | 0.1±1.4 (−0.4 to 0.6) |
0.61 | ||||
| Inflammatory marker | ||||||||
| ΔFibrinogen mg·dL−1 | 45.2±84.5 (15.2 to 75.1) |
<0.01 | 29.3±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.