Willem M C van Aalderen1, Jonathan Grigg2, Theresa W Guilbert3, Nicolas Roche4, Elliot Israel5, Richard J Martin6, Gene Colice7, Dirkje S Postma8, Elizabeth V Hillyer9, Anne Burden9, Victoria Thomas9, Julie von Ziegenweidt9, David Price10. 1. Department of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital AMC, Amsterdam, The Netherlands. 2. Blizard Institute, Queen Mary University London, London, UK. 3. Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio. 4. Cochin Hospital Group, AP-HP, University of Paris Descartes (EA2511), Paris, France. 5. Brigham and Women's Hospital and Harvard Medical School, Boston, Mass. 6. Department of Medicine, National Jewish Health and University of Colorado Denver, Denver, Colo. 7. Washington Hospital Center and George Washington University School of Medicine, Washington, DC. 8. University of Groningen, University Medical Center Groningen, Groningen, The Netherlands. 9. Research in Real Life, Ltd, Cambridge, UK. 10. Research in Real Life, Ltd, Cambridge, UK; Academic Primary Care, University of Aberdeen, Aberdeen, UK. Electronic address: dprice@rirl.org.
Abstract
BACKGROUND: Because randomized controlled trials of established pediatric asthma therapies are expensive and difficult to perform, observational studies may fill gaps in the evidence base. OBJECTIVES: To compare the effectiveness of representative small-particle inhaled corticosteroid (ICS) with that of standard size-particle ICS for children initiating or stepping up ICS therapy for asthma (analysis 1) and to compare the effectiveness of ICS dose step-up using small-particle ICS with adding long-acting β2-agonist (LABA) to the ICS (analysis 2). METHODS: These historical matched cohort analyses drew on electronic medical records of children with asthma aged 5 to 11 years. Variables measured during 2 consecutive years (1 baseline year for confounder definition and 1 outcome year) included risk-domain asthma control (no hospital attendance for asthma, acute oral corticosteroids, or lower respiratory tract infection requiring antibiotics) and rate of severe exacerbations (asthma-related emergency, hospitalization, or oral corticosteroids). RESULTS: In the initiation population (n = 797 in each cohort), children prescribed small-particle ICS versus standard size-particle ICS experienced greater odds of asthma control (adjusted odds ratio, 1.49; 95% CI, 1.10-2.02) and lower severe exacerbation rate (adjusted rate ratio, 0.56; 95% CI, 0.35-0.88). Step-up outcomes (n = 206 in each cohort) were also significantly better for small-particle ICS, with asthma control adjusted odds ratio of 2.22 (95% CI, 1.23-4.03) and exacerbations adjusted rate ratio of 0.49 (95% CI, 0.27-0.89). The number needed to treat with small-particle ICS to achieve 1 additional child with asthma control was 17 (95% CI, 9-107) for the initiation population and 5 (95% CI, 3-78) for the step-up population. Outcomes were not significantly different for stepped-up small-particle ICS dose versus ICS/LABA combination (n = 185 in each cohort). CONCLUSIONS: Initiating or stepping up the ICS dose with small-particle ICS rather than with standard size-particle ICS is more effective and shows similar effectiveness to add-on LABA in childhood asthma.
BACKGROUND: Because randomized controlled trials of established pediatric asthma therapies are expensive and difficult to perform, observational studies may fill gaps in the evidence base. OBJECTIVES: To compare the effectiveness of representative small-particle inhaled corticosteroid (ICS) with that of standard size-particle ICS for children initiating or stepping up ICS therapy for asthma (analysis 1) and to compare the effectiveness of ICS dose step-up using small-particle ICS with adding long-acting β2-agonist (LABA) to the ICS (analysis 2). METHODS: These historical matched cohort analyses drew on electronic medical records of children with asthma aged 5 to 11 years. Variables measured during 2 consecutive years (1 baseline year for confounder definition and 1 outcome year) included risk-domain asthma control (no hospital attendance for asthma, acute oral corticosteroids, or lower respiratory tract infection requiring antibiotics) and rate of severe exacerbations (asthma-related emergency, hospitalization, or oral corticosteroids). RESULTS: In the initiation population (n = 797 in each cohort), children prescribed small-particle ICS versus standard size-particle ICS experienced greater odds of asthma control (adjusted odds ratio, 1.49; 95% CI, 1.10-2.02) and lower severe exacerbation rate (adjusted rate ratio, 0.56; 95% CI, 0.35-0.88). Step-up outcomes (n = 206 in each cohort) were also significantly better for small-particle ICS, with asthma control adjusted odds ratio of 2.22 (95% CI, 1.23-4.03) and exacerbations adjusted rate ratio of 0.49 (95% CI, 0.27-0.89). The number needed to treat with small-particle ICS to achieve 1 additional child with asthma control was 17 (95% CI, 9-107) for the initiation population and 5 (95% CI, 3-78) for the step-up population. Outcomes were not significantly different for stepped-up small-particle ICS dose versus ICS/LABA combination (n = 185 in each cohort). CONCLUSIONS: Initiating or stepping up the ICS dose with small-particle ICS rather than with standard size-particle ICS is more effective and shows similar effectiveness to add-on LABA in childhood asthma.
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