Samatha Sonnappa1, Brett McQueen2, Dirkje S Postma3, Richard J Martin4, Nicolas Roche5, Jonathan Grigg6, Theresa Guilbert7, Caroline Gouder8, Emilio Pizzichini9, Akio Niimi10, Wanda Phipatanakul11, Alison Chisholm12, Ronald J Dandurand13, Alan Kaplan14, Elliot Israel15, Alberto Papi16, Willem M C van Aalderen17, Omar S Usmani18, David B Price19. 1. Observational and Pragmatic Research Institute Pte Ltd, Singapore; Department of Respiratory Paediatrics, Rainbow Children's Hospital, Bengaluru, India. 2. University of Colorado Denver, Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, Denver, Colo. 3. Department of Pulmonary Medicine and Tuberculosis, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands. 4. National Jewish Health and the University of Colorado Denver, Denver, Colo. 5. Respiratory and Intensive Care Medicine, Cochin Hospital (APHP), University Paris Descartes (EA2511), Paris, France. 6. Blizard Institute, Queen Mary University London, London, United Kingdom. 7. Division of Pulmonology Medicine, Cincinnati Children's Hospital & Medical Center, Cincinnati, Ohio. 8. Department of Respiratory Medicine, Mater Dei Hospital, Msida, Malta. 9. Department of Medicine, Federal University of Santa Catarina, Santa Catarina, Brazil. 10. Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 11. Department of Pediatrics, Boston Children's Hospital, Boston, Mass. 12. Respiratory Effectiveness Group, Oakington, Cambridge, United Kingdom. 13. Montreal Chest Institute, Meakins-Christie Laboratories and the McGill University Health Centre Research Institute, McGill University, Montreal, Canada. 14. Family Physician Airways Group of Canada, University of Toronto, Toronto, Ontario, Canada. 15. Pulmonary and Critical Care Division, Brigham & Women's Hospital, Harvard Medical School, Boston, Mass. 16. Department of Respiratory Medicine, University Hospital S. Anna, Ferrara, Italy. 17. Department of Pediatric Respiratory Diseases, Emma Children's Hospital AMC, Amsterdam, The Netherlands. 18. National Heart and Lung Institute, Imperial College London & Royal Brompton Hospital, London, United Kingdom. 19. 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@opri.sg.
Abstract
BACKGROUND: The particle size of inhaled corticosteroids (ICSs) may affect airway drug deposition and effectiveness. OBJECTIVE: To compare the effectiveness of extrafine ICSs (mass median aerodynamic diameter, <2 μm) versus fine-particle ICSs administered as ICS monotherapy or ICS-long-acting β-agonist combination therapy by conducting a meta-analysis of observational real-life asthma studies to estimate the treatment effect of extrafine ICSs. METHODS: MEDLINE and EMBASE databases were reviewed for asthma observational comparative effectiveness studies from January 2004 to June 2016. Studies were included if they reported odds and relative risk ratios and met all inclusion criteria (Respiratory Effectiveness Group/European Academy of Allergy and Clinical Immunology quality standards, comparison of extrafine ICSs with same or different ICS molecule, ≥12-month follow-up). End-point data (asthma control, exacerbations, prescribed ICS dose) were pooled. Random-effects meta-analysis modeling was used. The study protocol is published in the PROSPERO register CRD42016039137. RESULTS: Seven studies with 33,453 subjects aged 5 to 80 years met eligibility criteria for inclusion. Six studies used extrafine beclometasone propionate and 1 study used both extrafine beclometasone propionate and extrafine ciclesonide as comparators with fine-particle ICSs. The overall odds of achieving asthma control were significantly higher for extrafine ICSs compared with fine-particle ICSs (odds ratio, 1.34; 95% CI, 1.22-1.46). Overall exacerbation rate ratios (0.84; 95% CI, 0.73-0.97) and ICS dose (weighted mean difference, -170 μg; 95% CI, -222 to -118 μg) were significantly lower for extrafine ICSs compared with fine-particle ICSs. CONCLUSIONS: This meta-analysis demonstrates that extrafine ICSs have significantly higher odds of achieving asthma control with lower exacerbation rates at significantly lower prescribed doses than fine-particle ICSs.
BACKGROUND: The particle size of inhaled corticosteroids (ICSs) may affect airway drug deposition and effectiveness. OBJECTIVE: To compare the effectiveness of extrafine ICSs (mass median aerodynamic diameter, <2 μm) versus fine-particle ICSs administered as ICS monotherapy or ICS-long-acting β-agonist combination therapy by conducting a meta-analysis of observational real-life asthma studies to estimate the treatment effect of extrafine ICSs. METHODS: MEDLINE and EMBASE databases were reviewed for asthma observational comparative effectiveness studies from January 2004 to June 2016. Studies were included if they reported odds and relative risk ratios and met all inclusion criteria (Respiratory Effectiveness Group/European Academy of Allergy and Clinical Immunology quality standards, comparison of extrafine ICSs with same or different ICS molecule, ≥12-month follow-up). End-point data (asthma control, exacerbations, prescribed ICS dose) were pooled. Random-effects meta-analysis modeling was used. The study protocol is published in the PROSPERO register CRD42016039137. RESULTS: Seven studies with 33,453 subjects aged 5 to 80 years met eligibility criteria for inclusion. Six studies used extrafine beclometasone propionate and 1 study used both extrafine beclometasone propionate and extrafine ciclesonide as comparators with fine-particle ICSs. The overall odds of achieving asthma control were significantly higher for extrafine ICSs compared with fine-particle ICSs (odds ratio, 1.34; 95% CI, 1.22-1.46). Overall exacerbation rate ratios (0.84; 95% CI, 0.73-0.97) and ICS dose (weighted mean difference, -170 μg; 95% CI, -222 to -118 μg) were significantly lower for extrafine ICSs compared with fine-particle ICSs. CONCLUSIONS: This meta-analysis demonstrates that extrafine ICSs have significantly higher odds of achieving asthma control with lower exacerbation rates at significantly lower prescribed doses than fine-particle ICSs.
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