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Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial

Simon D. Fraser, Susannah Thackray-Nocera, Marica Shepherd, Rachel Flockton, Caroline Wright, Wayne Sheedy, Kayleigh Brindle, Alyn H. Morice, Paul M. Kaye, Michael G. Crooks, Simon P. Hart
ERJ Open Research 2020 6: 00534-2020; DOI: 10.1183/23120541.00534-2020
Simon D. Fraser
1Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK
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Susannah Thackray-Nocera
2Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK
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Marica Shepherd
2Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK
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Rachel Flockton
2Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK
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Caroline Wright
1Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK
2Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK
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Wayne Sheedy
1Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK
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Kayleigh Brindle
2Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK
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Alyn H. Morice
1Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK
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Paul M. Kaye
3York Biomedical Research Institute, University of York, York, UK
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Michael G. Crooks
1Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK
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Simon P. Hart
1Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK
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  • ORCID record for Simon P. Hart
  • For correspondence: s.hart@hull.ac.uk
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  • FIGURE 1
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    FIGURE 1

    CONSORT diagram. VAS: visual analogue scale; LCQ: Leicester cough questionnaire; KSQ: King's sarcoidosis questionnaire.

  • FIGURE 2
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    FIGURE 2

    Number of coughs in 24 h. Individual subject data showing 24-h cough counts at baseline and during treatment with azithromycin for 1 month and 3 months.

  • FIGURE 3
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    FIGURE 3

    Patient-reported outcomes. Individual subject data showing: a) cough severity visual analogue scale (VAS); b) urge to cough VAS; c) Leicester cough questionnaire (LCQ) scores; and d) King's sarcoidosis questionnaire (KSQ) general health scores at baseline and during treatment with azithromycin for 1 month and 3 months. VAS are 100 mm scales with lower numbers indicating lower cough severity and urge to cough. Higher scores on LCQ and KSQ indicate better cough- and sarcoidosis-related quality of life respectively.

Tables

  • Figures
  • TABLE 1

    Demographic and clinical details of 21 recruited patients with sarcoidosis

    Age years57 (48–71)
    Male/female9/12
    Years since diagnosis3 (1–13)
    Scadding chest radiography stage 1/2/32/6/13
    FEV1 % predicted87.5 (52–131)
    FVC % predicted91.5 (63–128)
    FEV1/FVC ratio0.75 (0.55–0.93)
    QTc interval ms427 (370–463)
    Oral corticosteroid therapy5
    Other immunomodulatory therapy0
    Inhaled corticosteroids3
    Number of coughs in 24 h228 (43–1950)
    Number of coughs·h−110 (2–81)
    Cough severity VAS mm31 (9–94)
    Urge to cough VAS mm26 (8–94)
    Leicester cough questionnaire score15.96 (5.07–19.74)
    King's sarcoidosis questionnaire GH score50.7 (23.8–100)

    Data are presented as median (range) or n. FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; VAS: visual analogue scale.

    • TABLE 2

      Secondary end-points

      Baseline1 months3 monthsChange from baseline at 3 monthsp-value (Friedman's test)
      Cough severity VASMedian 30.5 (9, 94)
      Mean 38.8 (25.7)
      24.0 (3, 88)
      33.7 (25.2)
      19.0 (0, 62)
      19.8 (17.7)
      −9.0 (−93, 20)
      −18.1 (27.6)
      0.009
      Cough urge VASMedian 26.0 (8, 94)
      Mean 38.7 (26.2)
      26.0 (2, 83)
      32.5 (23.3)
      18.5 (0, 61)
      22.2 (18.3)
      −13.0 (−83, 42)
      −15.7 (27.9)
      0.066
      LCQMedian 15.96 (5.07, 19.74)
      Mean 14.63 (4.07)
      17.6 (6.11, 20.75)
      16.68 (3.41)
      19.02 (14.93, 20.38)
      18.23 (1.76)
      1.85 (−1.17, 12.18)
      3.47 (4.0)
      0.006
      KSQ_GHMedian 50.7 (23.8, 100)
      Mean 52.93 (18.3)
      61.9 (29.4, 100)
      63.0 (18.1)
      72.25 (39.9, 100)
      69.63 (15.4)
      16.3 (−13.8, 47.1)
      17.5 (15.8)
      0.001
      KSQ_lungMedian 50.2 (29.0, 68.0)
      Mean 52.0 (10.4)
      52.6 (33.6, 77.1)
      54.5 (12.0)
      61.95 (41.6, 100)
      62.5 (14.0)
      6.5 (−1.3, 34.8)
      10.7 (11.3)
      0.001
      KSQ_lung_GHMedian 58.1 (36.7, 74.7)
      Mean 57.3 (9.1)
      58.7 (41.9, 86.1)
      61.9 (11.6)
      66.25 (50.1, 91.5)
      67.58 (10.4)
      10.7 (−2.3, 26.8)
      10.6 (8.3)
      0.0001

      Data are presented as median (range) and mean (sd). VAS: visual analogue scale; LCQ: Leicester cough questionnaire; KSQ: King's sarcoidosis questionnaire (presented as general health (GH), lung and combined lung-GH domains).

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      Vol 6 Issue 4 Table of Contents
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      Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial
      Simon D. Fraser, Susannah Thackray-Nocera, Marica Shepherd, Rachel Flockton, Caroline Wright, Wayne Sheedy, Kayleigh Brindle, Alyn H. Morice, Paul M. Kaye, Michael G. Crooks, Simon P. Hart
      ERJ Open Research Oct 2020, 6 (4) 00534-2020; DOI: 10.1183/23120541.00534-2020

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      Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial
      Simon D. Fraser, Susannah Thackray-Nocera, Marica Shepherd, Rachel Flockton, Caroline Wright, Wayne Sheedy, Kayleigh Brindle, Alyn H. Morice, Paul M. Kaye, Michael G. Crooks, Simon P. Hart
      ERJ Open Research Oct 2020, 6 (4) 00534-2020; DOI: 10.1183/23120541.00534-2020
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