BACKGROUND: Spacers are often used with pressurized metered-dose inhalers (pMDIs) to eliminate the need for coordinating inhalation with actuation.
OBJECTIVE: To investigate the real-life effectiveness of spacers prescribed for use with either extrafine- or fine-particle inhaled corticosteroids (ICSs).
METHODS: This historical matched cohort study examined anonymous medical record data over 2 years (1-year baseline, 1-year outcome) for patients with asthma aged 12 to 80 years initiating ICSs by pMDI with or without prescribed spacer. We compared outcomes for spacer versus no-spacer arms, matched for key baseline and asthma-related characteristics, within 2 ICS cohorts: (1) extrafine-particle ICS (beclomethasone) and (2) fine-particle ICS (fluticasone). Effectiveness end points were compared using conditional regression methods.
RESULTS: Matched spacer and no-spacer arms of the extrafine-particle ICS cohort each included 2090 patients (69% females; median age, 46-47 years) and the 2 arms of the fine-particle ICS cohort each included 444 patients (67% females; median age, 45 years). With extrafine-particle ICS, we observed no significant difference between spacer and no-spacer arms in severe exacerbation rate (primary end point): adjusted rate ratio, 1.01 (95% CI, 0.83-1.23). With fine-particle ICS, the severe exacerbation rate ratio with spacers was 0.77 (0.47-1.25). Oropharyngeal candidiasis incidence was low and similar in spacer and no-spacer arms for both ICS cohorts.
CONCLUSIONS: We found no evidence that prescribed spacer devices are associated with improved asthma outcomes for extrafine- or fine-particle ICS administered by pMDI. These findings challenge long-standing assumptions that spacers should improve pMDI effectiveness and indicate the need for pragmatic trials of spacers in clinical practice.
|Number of pages||14|
|Journal||The journal of allergy and clinical immunology. In practice|
|Early online date||18 Jan 2017|
|Publication status||Published - Jul 2017|
We thank Anne Burden, Vasilis Nikolaou, and Dr Alice Durieux for assistance with the analyses and Dr John Bukowski of WordsWorld Consulting for editorial assistance with the first draft of this manuscript, funded by Research in Real-Life Ltd, UK, under a subcontract by Observational and Pragmatic Research Institute Pte Ltd, Singapore. We also thank Alison Chisholm of the Respiratory Effectiveness Group for moderating the steering committee meetings at which study results were discussed.
- inhaled corticosteroid
- interquartile range
- mass median aerodynamic diameter
- pressurized metered-dose inhaler
- short-acting β-agonist