Theresa W Guilbert1, Gene Colice2, Jonathan Grigg3, Wim van Aalderen4, Richard J Martin5, Elliot Israel6, Dirkje S Postma7, Nicolas Roche8, Wanda Phipatanakul9, Elizabeth V Hillyer10, Jennifer M Evans10, Myrna B Dolovich11, David B Price12. 1. Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio. 2. Global Medicines Development, AstraZeneca, Gaithersburg, Md. 3. Blizard Institute, Queen Mary University London, London, United Kingdom. 4. Department of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital AMC, Amsterdam, the Netherlands. 5. Department of Medicine, National Jewish Health, and University of Colorado Denver, Denver, Colo. 6. Brigham and Women's Hospital and Harvard Medical School, Boston, Mass. 7. University of Groningen, Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, Groningen, the Netherlands. 8. Respiratory and Intensive Care Medicine, Cochin Hospital Group, AP-HP, University of Paris Descartes (EA2511), Paris, France. 9. Boston Children's Hospital and Harvard Medical School, Boston, Mass. 10. Observational and Pragmatic Research Institute Pte Ltd, Singapore. 11. Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. 12. Observational and Pragmatic Research Institute Pte Ltd, Singapore; Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, United Kingdom. Electronic address: dprice@rirl.org.
Abstract
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.
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.
Authors: Omer Kalayci; Hanan Abdelateef; César Fireth Pozo Beltrán; Zeinab A El-Sayed; René Maximiliano Gómez; Elham Hossny; Mário Morais-Almeida; Antonio Nieto; Wanda Phipatanakul; Paulo Pitrez; Gary Wk Wong; Paraskevi Xepapadaki; Nikolaos G Papadopoulos Journal: World Allergy Organ J Date: 2019-10-03 Impact factor: 4.084