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A prospective safety and feasibility study of metered cryospray for patients with chronic bronchitis in COPD

Justin L. Garner, Tawimas Shaipanich, Jorine E. Hartman, Christopher M. Orton, Cielito Caneja, Karin Klooster, John Thornton, Don D. Sin, Dirk-Jan Slebos, Pallav L. Shah
European Respiratory Journal 2020 56: 2000556; DOI: 10.1183/13993003.00556-2020
Justin L. Garner
1Department of Respiratory Medicine, Royal Brompton Hospital, London, UK
2Airways Diseases Section, National Heart and Lung Institute, Imperial College, London, UK
3Chelsea and Westminster Hospital, London, UK
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Tawimas Shaipanich
4St Paul's Hospital, Vancouver, BC, Canada
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Jorine E. Hartman
5Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
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  • ORCID record for Jorine E. Hartman
Christopher M. Orton
1Department of Respiratory Medicine, Royal Brompton Hospital, London, UK
2Airways Diseases Section, National Heart and Lung Institute, Imperial College, London, UK
3Chelsea and Westminster Hospital, London, UK
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Cielito Caneja
1Department of Respiratory Medicine, Royal Brompton Hospital, London, UK
3Chelsea and Westminster Hospital, London, UK
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Karin Klooster
5Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
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John Thornton
3Chelsea and Westminster Hospital, London, UK
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Don D. Sin
4St Paul's Hospital, Vancouver, BC, Canada
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Dirk-Jan Slebos
5Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands
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Pallav L. Shah
1Department of Respiratory Medicine, Royal Brompton Hospital, London, UK
2Airways Diseases Section, National Heart and Lung Institute, Imperial College, London, UK
3Chelsea and Westminster Hospital, London, UK
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  • For correspondence: pallav.shah@imperial.ac.uk
  • Article
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  • FIGURE 1
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    FIGURE 1

    Study protocol flowchart. Each treatment is separated by 30–45 days. MCS: metered cryospray; DSMB: data safety monitoring board.

  • FIGURE 2
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    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
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    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
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    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

  • Figures
  • Supplementary Materials
  • TABLE 1

    Baseline characteristics of patients

    Demographics
     Age years3567.2±7.0
     Male %1954.3
     BMI kg·m−23526.9±5.2
     Smoking pack-years3545 (33 to 68)
     Comorbidities352 (1 to 4)
     GOLD grade %
      I38.5
      II1028.5
      III2263.0
    Baseline medications %
     β-agonist1851.4
     Anticholinergic1851.4
     Corticosteroid1748.6
     Mucolytic617.1
     Antibiotic1131.4
    Lung function
     FEV1 L351.4±0.5
     FEV1 % predicted3550.2±14.5
     FVC L353.6±1.0
     FVC % predicted35103.6±16.9
     FEV1/FVC % predicted3538.5±10.1
     FIV1 L253.2±0.9
     Raw kPa·s·L−1270.6±0.3
    Exercise capacity
     6MWD m35400.6±86.8
    Symptoms
     mMRC352 (2 to 3)
     CAT#3422.7±7.1
     SGRQ
      Total3559.2±18.9
      Symptoms66.5±20.5
      Impacts48.3±22.4
      Activity74.1±19.0
     LCQ2385.0±27.7
     VAS#
      Rest3436.1±28.7
      Activity3468.6±23.9
    Mortality score
     BODE index353 (2 to 4)
    Inflammatory marker
     Plasma fibrinogen mg·dL−135341.1±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 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)0.29¶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
       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.

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      A prospective safety and feasibility study of metered cryospray for patients with chronic bronchitis in COPD
      Justin L. Garner, Tawimas Shaipanich, Jorine E. Hartman, Christopher M. Orton, Cielito Caneja, Karin Klooster, John Thornton, Don D. Sin, Dirk-Jan Slebos, Pallav L. Shah
      European Respiratory Journal Dec 2020, 56 (6) 2000556; DOI: 10.1183/13993003.00556-2020

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      A prospective safety and feasibility study of metered cryospray for patients with chronic bronchitis in COPD
      Justin L. Garner, Tawimas Shaipanich, Jorine E. Hartman, Christopher M. Orton, Cielito Caneja, Karin Klooster, John Thornton, Don D. Sin, Dirk-Jan Slebos, Pallav L. Shah
      European Respiratory Journal Dec 2020, 56 (6) 2000556; DOI: 10.1183/13993003.00556-2020
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