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NPJ Prim Care Respir Med. 2019 Feb 8;29(1):3. doi: 10.1038/s41533-019-0115-0.

Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma.

Author information

1
Observational and Pragmatic Research Institute, Singapore, Singapore.
2
University of Aberdeen, Aberdeen, UK.
3
Optimum Patient Care, Cambridge, UK.
4
University of Edinburgh, Edinburgh, UK.
5
Chiesi Ltd, Manchester, UK.
6
General Practitioners Research Institute, Groningen, The Netherlands.
7
Observational and Pragmatic Research Institute, Singapore, Singapore. dprice@opri.sg.
8
University of Aberdeen, Aberdeen, UK. dprice@opri.sg.
9
Optimum Patient Care, Cambridge, UK. dprice@opri.sg.

Abstract

Co-prescription of Aerochamber® spacer with non-extrafine beclometasone diproprionate (non-EF BDP) is common but unlicensed. We report a comparison of inhaled corticosteroid (ICS)-related adverse events between patients co-prescribed Aerochamber compared to the licensed Volumatic® spacer. We utilised two historical cohorts: questionnaire-based and electronic medical record (EMR)-based, to assess patient-reported and EMR-recorded adverse events in patients with asthma prescribed non-EF BDP. Marginal effect estimate (MEE) was calculated to determine non-inferiority of Aerochamber compared to Volumatic in terms of patient-reported oral thrush and hoarseness with margin of 0.13. Other patient-reported adverse events (sore throat, bruising, weight gain, and coughing), and EMR-recorded adverse events were also assessed. Rate of patient-reported oral adverse events were non-inferior in 385 patients prescribed Aerochamber compared to 155 patients prescribed Volumatic (27.7 vs 29.9%; MEE, -0.043; 95% CI, -0.133 to 0.047). Total patient-reported adverse events did not differ significantly between Aerochamber and Volumatic (53.3 vs 49.7% with ≥1 adverse event). The EMR-based study of 1471 matched pairs of subjects did not show significantly different number of EMR-recorded adverse events between Aerochamber and Volumatic (12.5 vs 12.8% with ≥1 adverse events). Co-prescribing Aerochamber with non-EF BDP does not increase the risk for patient-reported and EMR-recorded ICS-related adverse events compared to co-prescribing Volumatic.

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