In patients with asthma, coprescribing the unlicensed AeroChamber® spacer device along with non-extrafine beclometasone dipropionate (non-EF BDF), compared with use of the licensed Volumatic® spacer device, does not increase the risk for adverse events (AEs). A postauthorization safety study of the 2 spacer devices using a large UK primary care database was conducted using 2 separate historical cohorts — a questionnaire-based cohort and an electronic medical record (EMR)-based cohort — to evaluate patient-reported and EMR-reported AEs in individuals with asthma who were prescribed non-EF BDF. Results of the current study were published in the journal NPJ Primary Care Respiratory Medicine.
The primary objective of the study was to determine the noninferiority of non-EF BDF coprescribed with the AeroChamber spacer with that of non-EF BDF coprescribed with the Volumatic spacer, with respect to the frequency of patient-reported oral thrush or hoarseness per use of the asthma questionnaire over a single year. Additional AEs reported on the questionnaire included sore month/throat, cough, bruising, and abnormal weight gain. The secondary study objective involved a comparison of the EMR outcomes for non-EF BDF coprescribed with either the AeroChamber or the Volumatic spacer.
A total of 385 participants were prescribed the AeroChamber spacer and 155 participants were prescribed the Volumatic spacer. All patients in both the questionnaire-based study and the EMR-based study were ≤65 years old.
The rates of patient-reported oral AEs were noninferior in the AeroChamber spacer group to rates in the Volumatic spacer group (27.7% vs 29.9%, respectively; marginal effect estimate, −0.043; 95% CI, −0.133 to 0.047). Moreover, the total number of patient-reported AEs did not differ significantly between the AeroChamber spacer arm and the Volumatic spacer arm (53.3% vs 49.7%, respectively, with ≥1 AEs).
In the EMR-based study of 1471 matched pairs of participants, no statistically significantly different number of EMR-recorded AEs was reported with the AeroChamber spacer and the Volumatic spacer (12.5% vs 12.8%, respectively, with ≥1 AEs).
The investigators concluded that coprescribing the AeroChamber spacer with non-EF BDF does not increase the risk for patient-reported and EMR-reported inhaled corticosteroid–related AEs when compared with coprescribing the Volumatic spacer with non-EF BDF.
Ming SWY, Haughney J, Ryan D, et al. Comparison of adverse events associated with different spacers used with non-extrafine beclometasone dipropionate for asthma.NPJ Prim Care Respir Med. 2019;29(1):3.