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AFA Asthma Research Symposium Clinical Therapeutics: children

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AFA Asthma Research Symposium Clinical Therapeutics: children

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    1. AFA Asthma Research Symposium Clinical Therapeutics: children Peter van Asperen Macintosh Professor of Paediatric Respiratory Medicine Head, Department of Respiratory Medicine The Children’s Hospital at Westmead

    2. Clinical Therapeutics: children What we have learnt from research? Oral corticosteroids for acute asthma - effect of phenotype/age on response Leukotriene antagonists for intermittent wheeze - regular versus intermittent use Combination therapy - current evidence for its role versus its use in paediatric asthma management

    3. Oral Corticosteroids for Acute Asthma Effect of Phenotype/Age on Response ED & in hospital Oral Corticosteroid (OCS) - OCS effective for children hospitalised for asthma (Smith et al Cochrane Review 2003) - OCS effective for ED treatment of acute asthma (Rowe et al Cochrane Review 2001) - OCS not significantly different to placebo for ED treatment of pre-schoolers with viral induced wheezing ( Panikar et al NEJM 2009) Parent initiated oral corticosteroids (PIOCS) - PIOCS not effective for childhood intermittent (viral) wheezing (Oomen et al Lancet 2003;Vuillermin et al Cochrane Review 2006) - PIOCS effective for 6-14 yr olds with acute asthma – symptoms, HR utilisatn & school absence (Vuillermin et al BMJ 2010)

    4. Leukotriene Antagonists for Intermittent Wheeze Regular Versus intermittent use Regular LTRA’s (Bisgaard et al AJRCCM 2005) - RDBPCT Montelukast 4&5 mg over 12 mths in 549 2-5 yr olds - exacerbations M (1.60/pt/yr) vs P (2.34/pt/yr) [p<0.001] & OCS use (p<0.05) Intermittent LTRA’s (Robertson et al AJRCCM 2007) - RDBPCT Montelukast 4&5mg (min 7 days) in 201 2-14 yr olds - significantly reduced HC utilisation (OR 0.65 95%CI 0.47,0.89) - significantly improved patient & parent QOL (p<0.0001) Intermittent LTRA’s (Bacharier et al JACI 2008) - RDBPCT Mont 4mg vs Bud 1mg bd vs Placebo for 7 days in 238 1-5 yr olds - no diff EFD’s, HC utilisatn or OCS but active Rx reduced severity Short course LTRA’s verus Prednisolone (Schuh et al J Ped 2010) - RDBNIT Mont 4,5 or 10mg vs Pred 1mg/kg for 5 days in 130 2-17 yr olds D/C from ED following initial treatment - Treatment failure in 7.9% Pred gp vs 22.4% Mont gp (95% CI 2.4%-26.5%) MCRCT maint. LTRA vs interm. LTRA vs placebo (TBA)

    5. Combination Therapy in Paediatric Asthma Current Indications & Prescribing LABAs can be prescribed in children in combination with ICS (sal > 5 yrs; form > 12 yrs) if poor control limited evidence of efficacy & safety FDC 40% of prescribed preventer meds in 2-14yr olds 40% FDC scripts not preceded by ICS or FDC 2yrs prior 60% 4-14yr olds initiated on FDC-1 script in 12mths 50% 4-14 yr olds continuing FDC-1-2 scripts in 12 mths 20% pre-schoolers with Dx asthma receive FDC (Phillips et al MJA 2007; 187:10)

    6. Combination Therapy in Paediatric Asthma Evidence for Efficacy (Cochrane Review 2009 Issue 3 CD 007949) Total of 25 trials representing 31 control-intervention comparisons involving 5,572 children who met inclusion criteria Mean age 10 yrs male predominance – no studies < 4yrs Two interventions examined - ICS + LABA vs ICS (same dose) (n=24) - ICS + LABA vs ICS x 2 (n=7) Majority of patients inadequately controlled on ICS (19/24 & 6/7) Primary outcome - exacerbation requiring systemic steroids Secondary outcomes – hospital admission, symptoms, reliever use, QOL, lung function & adverse events

    7. Combination Therapy in Paediatric Asthma Evidence for Efficacy (Cochrane Review 2009 Issue 3 CD 007949) ICS + LABA vs ICS (same dose) - 24 control-intervention comparisons in 4,625 children - no diff exacerbations (RR 0.92[0.60,1.40] n=8), hospitalisations (RR1.65[0.83,3.25] n=6), symptom free days, reliever use, QOL or adverse events - improved FEV1 0.08 (0.06,0.11) litres n=9 ICS +LABA vs ICS x 2 - 7 control-intervention comparisons in 1048 children - no diff exacerbations (RR 1.50[0.65,3.48] n=3), hospitalisations (RR 2.21[0.74,6.64] n=2); insufficient data for other 20 outcomes - improved am PEF 7.55(3.57,11.53) L/min n=4 & pm PEF 5.5(1.21,9.79) n=3 and better growth 1.2(0.72,1.7) cm/yr n=2

    8. Combination Therapy in Paediatric Asthma BADGER Study (Lemanske et al NEJM 2010) RDBCOS in 182 (480 enrolled) children aged 6-17 yrs with asthma uncontrolled on FP 100mcg bd 2-8 wk run in followed by random order 16 wk Rx with FP 250 bd, FP 100/50 bd, FP 100 bd + M 5/10mg LABA step up significantly more likely to provide best response (prednisolone use, ACD &FEV1) but many children responded best to ICS or M step up - need to monitor & adjust therapy Asthma control only predictor of response – better controlled more likely to respond best to LABA Long term safety of LABA not addressed

    10. Clinical Therapeutics: children What further research is required? MORE PAEDIATRIC CLINICAL TRIALS - Wheeze phenotype & genotype specific trials - LABA/Combination therapy trials - Novel Medications - parallel paediatric trials OPTIMISING MEDICATION USE - Medication prescribing - Medication adherence - Medication delivery OTHER THERAPEUTIC INTERVENTIONS - CAM, Allergen Avoidance/Exposure, Education - Asthma Prevention - Immunomodulation, Virus protection

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