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P203 A comparison of adverse events associated with licensed and unlicensed spacer use with non-extrafine beclometasone dipropionate treatment in a real-life patient population with asthma in the uk
  1. S Wan Yau Ming1,
  2. J Haughney2,
  3. D Ryan3,
  4. S Patel4,
  5. M Ochel4,
  6. S Thornhill1,
  7. D Price1
  1. 1Observational and Pragmatic Research Institute, Singapore
  2. 2University of Aberdeen, Aberdeen, UK
  3. 3Optimum Patient Care, Cambridge, UK
  4. 4Chiesi Ltd, Manchester, UK

Abstract

Background Spacers may be compatible but unlicensed for an inhaler device. A prior study showed that co-prescription of unlicensed spacers with non-extrafine (non-EF) beclometasone dipropionate (BDP) asthma therapy was common.1 This study aimed to compare the occurrence of patient-reported inhaled corticosteroid (ICS)-related adverse events (AEs) in patients with asthma co-prescribed the licensed Volumatic or unlicensed Aerochamber spacer with their non-EF BDP therapy.

Method A cross-sectional study using completed questionnaires and data extracted from the Optimum Patient Care Research Database including patients with asthma, aged ≤65 years,≥2 prescriptions for non-EF BDP and co-prescription of either a Volumatic or Aerochamber spacer. Patient characterisation was performed for the year prior to receipt of the completed questionnaire. AEs captured via questionnaire included continual sore mouth/throat, oral thrush, hoarse voice, bruising, weight gain and cough. The primary outcome was non-inferiority of the proportion of patient-reported oral candidiasis (reported as oral thrush/hoarse voice). The two spacer groups were compared using logistic regression, adjusted for gender, ICS average dose and smoking status. Non-inferiority was claimed if the upper 95% confidence interval (CI) of the marginal effect estimate was <0.13. Comparisons by age (<16, 16–65,≥65 years) and ICS dose (<1000 µg,≥1000 µg) were additionally performed.

Results Of the patients co-prescribed the licensed Volumatic spacer (n=155), 29.9% reported oral candidiasis, compared to 27.7% of patients co-prescribed the unlicensed Aerochamber device (n=385, p=0.622). The marginal effect estimate was −0.043 (95%CI −0.133, 0.047) and the Aerochamber was determined to be non-inferior to the Volumatic spacer. In terms of the total number of reported AEs, there were no significant differences for the main population (≤65 years) (p=0.797), 16–65 years (p=0.875),<16 years (p=0.687),≥65 years (p=0.425), high dose (p=0.084) and low dose (p=0.443) groups between those co-prescribed a Volumatic or an Aerochamber spacer.

Conclusion Co-prescription of the unlicensed Aerochamber spacer with non-EF BDP asthma therapy, in recommended patient groups, does not increase the risk of developing oral candidiasis or other ICS-related AEs, as compared to co-prescription of the licensed, Volumatic device.

Reference

  1. ICARUS study submitted to PCRS2017.

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