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Multiple breath washout in bronchiectasis clinical trials: is it feasible?

Katherine O'Neill, Kathryn Ferguson, Denis Cosgrove, Michael M. Tunney, Anthony De Soyza, Mary Carroll, James D. Chalmers, Timothy Gatheral, Adam T. Hill, John R. Hurst, Christopher Johnson, Michael R. Loebinger, Gerhild Angyalosi, Charles S. Haworth, Renee Jensen, Felix Ratjen, Clare Saunders, Christopher Short, Jane C. Davies, J. Stuart Elborn, Judy M. Bradley
ERJ Open Research 2020 6: 00363-2019; DOI: 10.1183/23120541.00363-2019
Katherine O'Neill
1Wellcome–Wolfson Institute for Experimental Medicine, Queen's University – Belfast, Belfast, UK
15On behalf of the BRONCH-UK consortium
16On behalf of the i-BEST-1 Trial Team
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  • For correspondence: k.oneill@qub.ac.uk
Kathryn Ferguson
2Belfast Health and Social Care Trust, Belfast, UK
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Denis Cosgrove
2Belfast Health and Social Care Trust, Belfast, UK
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Michael M. Tunney
3School of Pharmacy, Queen's University – Belfast, Belfast, UK
16On behalf of the i-BEST-1 Trial Team
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Anthony De Soyza
4Newcastle University, Newcastle upon Tyne, UK
15On behalf of the BRONCH-UK consortium
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  • ORCID record for Anthony De Soyza
Mary Carroll
5University Hospital Southampton NHS Foundation Trust, Southampton, UK
15On behalf of the BRONCH-UK consortium
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James D. Chalmers
6University of Dundee, College of Medicine, Dundee, UK
15On behalf of the BRONCH-UK consortium
16On behalf of the i-BEST-1 Trial Team
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Timothy Gatheral
7Department of Respiratory Medicine, University Hospitals of Morecambe Bay NHS Foundation Trust, Morecambe Bay, UK
15On behalf of the BRONCH-UK consortium
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Adam T. Hill
8Royal Infirmary and University of Edinburgh, Edinburgh, Scotland, UK
15On behalf of the BRONCH-UK consortium
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John R. Hurst
9UCL Respiratory, University College London, London, UK
15On behalf of the BRONCH-UK consortium
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Christopher Johnson
10Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, UK
15On behalf of the BRONCH-UK consortium
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Michael R. Loebinger
11National Heart and Lung Institute, Imperial College London, London, UK
12Royal Brompton and Harefield NHS Foundation Trust, London, UK
15On behalf of the BRONCH-UK consortium
16On behalf of the i-BEST-1 Trial Team
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Gerhild Angyalosi
13Novartis Pharma AG, Basel, Switzerland
16On behalf of the i-BEST-1 Trial Team
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Charles S. Haworth
10Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, UK
16On behalf of the i-BEST-1 Trial Team
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Renee Jensen
14University of Toronto, Toronto, Canada
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Felix Ratjen
14University of Toronto, Toronto, Canada
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Clare Saunders
11National Heart and Lung Institute, Imperial College London, London, UK
12Royal Brompton and Harefield NHS Foundation Trust, London, UK
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Christopher Short
11National Heart and Lung Institute, Imperial College London, London, UK
12Royal Brompton and Harefield NHS Foundation Trust, London, UK
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Jane C. Davies
11National Heart and Lung Institute, Imperial College London, London, UK
12Royal Brompton and Harefield NHS Foundation Trust, London, UK
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J. Stuart Elborn
1Wellcome–Wolfson Institute for Experimental Medicine, Queen's University – Belfast, Belfast, UK
15On behalf of the BRONCH-UK consortium
16On behalf of the i-BEST-1 Trial Team
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Judy M. Bradley
1Wellcome–Wolfson Institute for Experimental Medicine, Queen's University – Belfast, Belfast, UK
15On behalf of the BRONCH-UK consortium
16On behalf of the i-BEST-1 Trial Team
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  • FIGURE 1
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    FIGURE 1

    Central over-reading outcome from BronchUK Clinimetrics study (testing sessions from 142 subjects over 8 visits). MBW: multiple breath washout. #: re-run of tests completed but did not resolve the misalignment or re-run not possible due to A-files not being saved.

  • FIGURE 2
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    FIGURE 2

    Central over-reading outcome from i-BEST-1 trial (testing sessions from 40 subjects over 8 visits). MBW: multiple breath washout. #: re-run of tests completed but did not resolve the misalignment or re-run not possible due to A-files not being saved.

  • FIGURE 3
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    FIGURE 3

    Combined success rate. Clin: Clinimetrics.

Tables

  • Figures
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  • TABLE 1

    Clinimetrics (Clin) multiple breath washout data quality control according to site

    Naïve sitesNon-naïve sitesOverall
    SiteClin site 1Clin site 2Clin site 3Clin site 4Clin site 5Clin site 6Clin site 7
    Total number of testing sessions attempted1165958889115819
    Site success rate81/116 (70%)36/59 (61%)50/58 (86%)65/88 (72%)84/91 (92%)140/158 (89%)12/19 (63%)468/589
    Combined success rate naïve versus non-naïve167/233 (72%)301/356 (85%)79%
    Site success rate first 6 months versus remainder81%:65%81%:53%94%: 83%74%:74%72%:100%94%:88%64%:60%
  • TABLE 2

    i-BEST-1 multiple breath washout (MBW) data quality control according to site

    Naïve sitesNon-naïve sitesOverall
    Sitei-BEST site 1i-BEST site 2i-BEST site 3i-BEST site 4i-BEST site 5i-BEST site 6i-BEST site 7i-BEST site 8i-BEST site 9i-BEST site 10i-BEST site 11
    Number of testing sessions attempted2048465122010432813
    Overall success rate6/20 (30%)35/48 (73%)0/4 (0%)34/65 (52%)9/12 (75%)15/20 (75%)6/10 (60%)0/4 (0%)26/32 (81%)6/8 (75%)0/13 (0%)137/236
    Combined success rate naïve versus non-naïve105/179 (59%)32/57 (56%)58%
    Success rate first 6 months versus remainder46%:0%68%:91%0%:0%48%:55%75%:n/a93%:100%60%:n/a0%:0%84%:72%86%:0%0%:0%

    n/a: No MBW data submitted during this timeframe.

    • TABLE 3

      Key results from multiple breath washout (MBW) training, certification and data quality control in bronchiectasis research settings

      Knowledge and confidence with MBW testing was increased with the training programme
      68% of sites completed certification within 6 months
      Most common barriers to completing MBW certification in bronchiectasis sites were the lack of time and available volunteers to practice testing
      Success rates were 79% (Clinimetrics study) and 58% (i-BEST-1 study)
      In the Clinimetrics study, there was no difference in age (p=0.10) or disease severity (p=0.90) as measured by forced expiratory volume in 1 s (at baseline) in those subjects with successful versus those with failed test sessions
      In the i-BEST-1 study, longer times to certification, a higher percentage of naïve sites and patients with worse lung function may have contributed to the lower success rate
      Combination of success rate data from both studies showed that success rates were higher in non-naïve sites (81%) compared to naïve sites (66%)

    Supplementary Materials

    • Figures
    • Tables
    • Supplementary Material

      Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

      Appendix 1 00363-2019.supplement1

      Appendix 2 00363-2019.supplement2

      Appendix 3 00363-2019.supplement3

      Appendix 4 00363-2019.supplement4

      Appendix 5 00363-2019.supplement5

      Appendix 6 00363-2019.supplement6

      Appendix 7 00363-2019.supplement7

      Appendix 8 00363-2019.supplement8

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    Multiple breath washout in bronchiectasis clinical trials: is it feasible?
    Katherine O'Neill, Kathryn Ferguson, Denis Cosgrove, Michael M. Tunney, Anthony De Soyza, Mary Carroll, James D. Chalmers, Timothy Gatheral, Adam T. Hill, John R. Hurst, Christopher Johnson, Michael R. Loebinger, Gerhild Angyalosi, Charles S. Haworth, Renee Jensen, Felix Ratjen, Clare Saunders, Christopher Short, Jane C. Davies, J. Stuart Elborn, Judy M. Bradley
    ERJ Open Research Oct 2020, 6 (4) 00363-2019; DOI: 10.1183/23120541.00363-2019

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    Multiple breath washout in bronchiectasis clinical trials: is it feasible?
    Katherine O'Neill, Kathryn Ferguson, Denis Cosgrove, Michael M. Tunney, Anthony De Soyza, Mary Carroll, James D. Chalmers, Timothy Gatheral, Adam T. Hill, John R. Hurst, Christopher Johnson, Michael R. Loebinger, Gerhild Angyalosi, Charles S. Haworth, Renee Jensen, Felix Ratjen, Clare Saunders, Christopher Short, Jane C. Davies, J. Stuart Elborn, Judy M. Bradley
    ERJ Open Research Oct 2020, 6 (4) 00363-2019; DOI: 10.1183/23120541.00363-2019
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