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Original research
Oscillatory positive expiratory pressure therapy in COPD (O-COPD): a randomised controlled trial
  1. Saeed M Alghamdi1,2,
  2. Abdullah S Alsulayyim2,3,
  3. Ali M Alasmari2,4,
  4. Keir E J Philip2,
  5. Sara C Buttery2,
  6. Winston A S Banya2,
  7. Michael I Polkey2,
  8. Surinder S Birring5,
  9. Nicholas S Hopkinson2
  1. 1Clinical Technology, Umm Al-Qura University, Makkah, Saudi Arabia
  2. 2National Heart and Lung Institute, Imperial College London, London, UK
  3. 3Faculty of Applied Medical Sciences, Jazan University, Jazan, Saudi Arabia
  4. 4College of Medical Rehabilitation, Taibah University, Madinah, Saudi Arabia
  5. 5Respiratory Medicine, Kings College Hospital, London, UK
  1. Correspondence to Professor Nicholas S Hopkinson, Imperial College London, London SW7 2BX, UK; n.hopkinson{at}ic.ac.uk

Abstract

Background Oscillatory positive expiratory pressure (OPEP) devices are intended to facilitate sputum clearance and reduce cough, but there is limited evidence for their effectiveness in COPD, or to guide patient selection. We aimed to assess the impact of OPEP therapy on quality of life and objective measures of cough and sleep disturbance in patients with COPD with regular sputum production.

Methods We enrolled stable patients with COPD, who reported sputum production every day or most days, into an assessor-blind, parallel-group, randomised controlled trial comparing 3 months of using an Acapella device against usual care (including use of the active cycle of breathing technique). The primary outcome was cough-related quality of life measured using the Leicester Cough Questionnaire (LCQ). Secondary outcomes included fatigue (Functional Assessment of Chronic Illness Therapy, FACIT score) and generic quality of life (EuroQol-5 Dimensions, EQ-5D). In a substudy (n=45), objective monitoring of cough and disturbance/movement during sleep were also available.

Results 122 participants (61/61 OPEP/control) were recruited, 40% female, 17% smokers, FEV1 38 (25–56)% predicted, and age 62±10 years. 103 completed the study (55/48 OPEP/control). Use of OPEP was associated with an improvement in LCQ compared with controls; MD (95% CI) 1.03 (0.71 to 2.10); (p=0.03), FACIT score 4.68 (1.34 to 8.02); (p<0.001) and EQ-5D 4.00 (0.49 to 19.75); (p=0.04). There was also an improvement in cough frequency −60 (−43 to −95) coughs/24 hours (p<0.001), but no statistically significant effect on sleep disturbance was identified.

Conclusions Regular use of an Acapella device improves symptoms and quality of life in people with COPD who produce sputum daily or most days.

Trial registration number ISRCTN44651852.

  • COPD Exacerbations
  • Cough/Mechanisms/Pharmacology
  • Respiratory Muscles

Data availability statement

Data are available on reasonable request.

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Data availability statement

Data are available on reasonable request.

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Footnotes

  • Twitter @saeedmordy, @keirphilip, @COPDdoc

  • Contributors SMA, NSH, MIP and SSB developed the idea and designed the study protocol. SMA, NSH, MIP and SSB designed and wrote the study protocol draft. SMA, NSH, KEJP, SCB, ASA and AMS planned the data collection and facilitated patients’ recruitment. SMA, NSH and WASB planned the statistical analysis. WASB reviewed the data analysis and provided critical insights. NSH, MIP, and SSB supervised the O-COPD clinical trial and provided critical input.

    NSH is guarantor for the overall content of the paper and all authors approved and contributed to the final written manuscript.

  • Funding This study was funded by Umm-Al Qura University, the Saudi Arabia Cultural Bureau in London, and Imperial College London.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • -Data availability free text The data underpinning the results reported in this article, once de-identified (text, tables, figures and online supplements) will be available to researchers who make a methodologically sound proposal within one year following article publication. In addition, a protocol for the study and a plan for statistical analysis will be provided on request. To submit a proposal, please contact n.hopkinson@ic.ac.uk. A data access agreement must be signed by data requestors to gain access.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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