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
- Respiratory Muscles
Data availability statement
Data are available on reasonable request.
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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 email@example.com. A data access agreement must be signed by data requestors to gain access.
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