Figures
- FIGURE 1
Study protocol flowchart. Each treatment is separated by 30–45 days. MCS: metered cryospray; DSMB: data safety monitoring board.
- FIGURE 2
Mean changes in patient-reported outcomes over 12 months. a) St George's Respiratory Questionnaire (SGRQ) total score; b) SGRQ symptoms score; c) SGRQ impacts score; d) SGRQ activity score. MCID: minimal clinically important difference. *: p<0.05 compared to baseline.
- FIGURE 3
Mean changes in patient-reported outcomes over 12 months. a) COPD Assessment Test score; b) Leicester Cough Questionnaire score; c) modified Medical Research Council dyspnoea score; and d) visual analogue scale (activity). MCID: minimal clinically important difference. *: p<0.05 compared to baseline.
- FIGURE 4
Mean changes in the total St George's Respiratory Questionnaire (SGRQ) total and domain scores over 12 months in those individuals with baseline total SGRQ scores of >50 points. a) SGRQ total score; b) SGRQ symptoms score; c) SGRQ impacts score; d) SGRQ activity score. MCID: minimal clinically important difference. *: p<0.05 compared to baseline.
Tables
- TABLE 1
Baseline characteristics of patients
Demographics Age years 35 67.2±7.0 Male % 19 54.3 BMI kg·m−2 35 26.9±5.2 Smoking pack-years 35 45 (33 to 68) Comorbidities 35 2 (1 to 4) GOLD grade % I 3 8.5 II 10 28.5 III 22 63.0 Baseline medications % β-agonist 18 51.4 Anticholinergic 18 51.4 Corticosteroid 17 48.6 Mucolytic 6 17.1 Antibiotic 11 31.4 Lung function FEV1 L 35 1.4±0.5 FEV1 % predicted 35 50.2±14.5 FVC L 35 3.6±1.0 FVC % predicted 35 103.6±16.9 FEV1/FVC % predicted 35 38.5±10.1 FIV1 L 25 3.2±0.9 Raw kPa·s·L−1 27 0.6±0.3 Exercise capacity 6MWD m 35 400.6±86.8 Symptoms mMRC 35 2 (2 to 3) CAT# 34 22.7±7.1 SGRQ Total 35 59.2±18.9 Symptoms 66.5±20.5 Impacts 48.3±22.4 Activity 74.1±19.0 LCQ 23 85.0±27.7 VAS# Rest 34 36.1±28.7 Activity 34 68.6±23.9 Mortality score BODE index 35 3 (2 to 4) Inflammatory marker Plasma fibrinogen mg·dL−1 35 341.1±72.5 Data are presented as n, mean±sd or median (interquartile range), unless otherwise stated. BMI: body mass index; GOLD: Global Initiative for Chronic Obstructive Lung Disease; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; FIV1: forced inspiratory volume in 1 s; 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: BMI, airflow obstruction, dyspnoea and exercise capacity. #: pre-treatment 1 data used.
- 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.
Supplementary Material
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Supplementary material ERJ-00556-2020.SUPPLEMENT
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