Treatment of Pediatric asthma-(Ho-Chang Kuo, MD)郭和昌醫師
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2010 An update of treatment on Pediatric asthma based on the GINA guideline and literature review.
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Treatment of Pediatric asthma-(Ho-Chang Kuo, MD)郭和昌醫師
- 1. Paediatric asthma management - from theory to clinical practice Sun rise of River Mississippi, New Orleans, LA 郭和昌 醫師 高雄長庚兒童過敏免疫風濕科 Mar 27, 2010, AIR 南區季會
- 4. 台北地區學童氣喘盛行率
- 5. Asthma prevalence is increasing at the highest rate in children Trends in the prevalence of asthma, by age, in the USA (1985–1996) Braman SS. Chest 2006; 130 : 4S–12S. 10 years Age (years) <18 18 - 44 45 - 64 65+ Total (all ages) 80 70 60 50 40 30 20 85 86 87 88 89 90 91 92 93 94 95 96 Rate/1,000 persons Years
- 8. Holliday Inn, New Orleans, LA Which is real?
- 9. Café Du Monde, more than 100 yrs
- 10. Asthma restricts activities in adults and children ( 造成許多的影響 ) Neffen H et al. Pan American J Public Health 2005; 17: 191–197 .
- 13. Levels of Asthma Control * Any exacerbation should prompt review of maintenance treatment to ensure that it is adequate. † By definition, an exacerbation in any week makes that an uncontrolled asthma week. One in any week† One or more/year* None Exacerbations < 80% predicted or personal best (if known) Normal Lung function (PEF or FEV 1 ) More than twice/week None (twice or less/week) Need for reliever/ rescue treatment Any None Nocturnal symptoms/awakening Any None Limitations of activities Three or more features of partly controlled asthma present in any week More than twice/week None (twice or less/week) Daytime symptoms Uncontrolled Partly Controlled (Any measure present in any week) Controlled (All of the following) Characteristic
- 15. The comparison of GINA Guideline Control Measure and Childhood-ACT in the evaluation of Asthmatic Children ( 高雄長庚 ) N=63
- 16. The GINA guideline-based controlled group had higher C-ACT scores than the partly controlled and uncontrolled groups
- 19. controlled partly controlled uncontrolled exacerbation LEVEL OF CONTROL maintain and find lowest controlling step consider stepping up to gain control step up until controlled treat as exacerbation TREATMENT OF ACTION TREATMENT STEPS REDUCE INCREASE STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 REDUCE INCREASE
- 20. * Receptor antagonist or synthesis inhibitors 1. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007 . GINA stepwise management of asthma in adults and children >5 years Step 1 Step 2 Step 3 Step 4 Step 5 Asthma education Environmental control As needed rapid-acting 2-agonist As-needed rapid-acting 2-agonist Controller options Select one Select one Add one or more Add one or more Low-dose inhaled ICS Low-dose ICS plus long-acting 2 -agonist Medium- or high-dose ICS plus long-acting 2 -agonist Oral glucocorticosteroid (lowest dose) Leukotriene modifier* Medium- or high-dose ICS Leukotriene modifier Anti-IgE treatment Low-dose ICS plus leukotriene modifier Sustained-release theophylline Low-dose ICS plus sustained-release theophylline Preferred option
- 23. Step-down treatment in asthma N Engl J Med 2007;356:2027-39.
- 24. N Engl J Med 2007;356:2027-39. N=500 N=169 N=166 N=165
- 25. N Engl J Med 2007;356:2027-39.
- 27. St. Louis Cathedral and Jackson Square, New Orleans, LA
- 28. The red lady, street car, New Orleans 慾望街車
- 31. N Engl J Med. 2010 Mar 3 Step-up tx in childhood asthma with ICS
- 32. N Engl J Med. 2010 Mar 3
- 33. N Engl J Med. 2010 Mar 3
- 34. N Engl J Med. 2010 Mar 3 P = 0.02 P = 0.004 P = 0.004 P = 0.002
- 35. N Engl J Med. 2010 Mar 3 Beta-2 adrenergic receptors, position 16 (P = 0.49) (P = 0.009), P = 0.52 (P = 0.37)
- 36. N Engl J Med. 2010 Mar 3 no differences P = 0.006
- 39. Inhaled therapies vs. oral therapies
- 42. FP compared with MON for treatment of children with asthma Ostrom NK et al. J Pediatr 2005; 147 : 213–220. Mean change at endpoint MON FP p-value FEV 1 (%) 4.60 10.6 0.002 AM PEF (L/min) 23.0 39.9 0.004 PM PEF (L/min) 20.4 35.5 0.02 Night-time asthma symptom score -0.19 -0.40 <0.001 Total albuterol use (puffs/day) -1.23 -1.43 0.018 Night-time albuterol use (puffs/day) -0.21 -0.39 <0.001 % rescue-free days 35.0 45.1 0.002
- 43. FP compared with MON for treatment of children with asthma Zeiger RS et al. J Clin Immunol 2006; 117 : 45–52. Asthma control responses to FP and MON Baseline mean Adjusted MON mean Adjusted FP mean p-value Average asthma control days per week 2.2 5 4.3 <0.0001 Overall asthma control questionnaire score 0.96 0.59 0.76 0.0009 FEV 1 /FVC (%) 80.1 82.2 79.0 <0.0001 AM PEF (L/min) 307.6 334.2 324.8 0.0002 R5 (kPA/L/s) 0.64 0.60 0.63 0.0027 AX (kPA/L) 1.60 1.25 1.53 0.0003 eNO (ppb) 39.5 20.6 30.9 0.0028
- 45. Salmeterol/fluticasone propionate (SFC) gives optimal control of asthma in children
- 47. PEACE study
- 50. PEACE study: patient demography and baseline characteristics Maspero J et al. Clin Ther. 2008 Aug;30(8):1492-504. Characteristic SFC (n=281) MON (n=267) Age in years, mean (SD) 9.3 (2.15) 9.3 (2.12) Male, n (%) 156 (56) 179 (67) Diary card data, mean (SD):* – morning PEF (L/min) – % predicted morning PEF – % symptom-free days – % nights with no awakenings – % rescue-free days 216.0 (72.6) 74.4 (17.8) 16.8 (26.5) 69.3 (32.8) 13.4 (21.2) 214.0 (67.1) 74.3 (17.1) 15.3 (22.2) 66.0 (32.8) 11.3 (20.0) Lung function, mean at baseline visit (SD): – FEV 1 (L) – % predicted FEV 1 – % reversibility in FEV 1 1.49 (0.43) 72.9 (6.8) 26.0 (14.0) 1.48 (0.43) 72.9 (6.9) 26.3 (12.2) *Over last 7 days of run-in
- 52. Symptom-free and rescue-free days and nights with no awakenings: SFC compared with MON Maspero J et al. Clin Ther. 2008 Aug;30(8):1492-504. SFC:MON Odds ratio 95% CI p-value % symptom-free 24-hour periods 1.74 1.07, 2.82 0.025 % rescue-free 24-hour periods 3.24 2.09, 5.02 <0.001 % nights with no awakenings 2.33 0.73, 7.47 .0154
- 53. Percentage of subjects with controlled asthma: SFC compared with MON Maspero J et al. Clin Ther. 2008 Aug;30(8):1492-504. 83.3% in the SFC group and 66.7% in the MON group, p<0.001 0 10 20 30 40 50 60 70 80 90 % controlled subjects 1 2 3 4 5 6 7 8 9 10 11 12 Weeks SFC MON
- 54. Mean exacerbation rate over 12 weeks: SFC compared with MON 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 SFC MON Weeks 1–12 Mean exacerbation rate An exacerbation was defined as worsening asthma requiring: emergency room visit, hospitalisation, unscheduled clinic visit requiring treatment with systemic corticosteroids or nebulised salbutamol, >12 puffs per day of salbutamol or >10 puffs per 2 consecutive days of salbutamol p<0.001 (SFC/MON ratio: 0.40; 95% CI: 0.29, 0.57) Maspero J et al. Clin Ther. 2008 Aug;30(8):1492-504.
- 55. Most common adverse events experienced during treatment in the PEACE study Maspero J et al. Clin Ther. 2008 Aug;30(8):1492-504. Adverse events, n (%) SFC (n=281) MON (n=267) Any event 155 (55) 153 (57) Headache 66 (23) 72 (27) Pyrexia 24 (9) 18 (7) Pharyngitis 17(6) 17 (6) Cough 13 (5) 16 (6) Allergic rhinitis 13 (5) 10 (4) Nasopharyngitis 14 (5) 8 (3) Rhinorrhoea 15 (5) 8 (3) Sinusitis 9 (3) 13 (5) Abdominal pain 9 (3) 13 (5)
- 58. A new trend of souvenirs collection
- 60. Compliance
- 61. Patient compliance with asthma medication 1. Horne R. Chest 2006; 130 : 65–72. Poor Compliance Concern about side effects Patient’s negative attitude towards medicines in general Past experience Views of others Cultural influences Practical difficulties Patient’s perceived need
- 67. Mississippi River, New Orleans, LA
- 68. Jambalaya, New Orleans, LA
- 69. J Allergy Clin Immunol 2009;123:411-6.
- 70. J Allergy Clin Immunol 2009;123:411-6.
- 71. Physicians treating children with a Parental history of asthma, increased eNO levels, low PC20 values, or a history of ICS use can expect the best long-term outcomes with ICS therapy compared with treatment with leukotriene receptor antagonists. J Allergy Clin Immunol 2009;123:411-6.
- 72. Eur J Pediatr (2008) 167:731–736 Inhaled corticosteroids or montelukast as the preferred primary long-term treatment for pediatric asthma?
- 75. Allergy Asthma Immunol Res. 2010 January;2(1):1-13.
- 76. Allergy Asthma Immunol Res. 2010 January;2(1):1-13.
- 77. Allergy Asthma Immunol Res. 2010 January;2(1):1-13.
Editor's Notes
- Notes Asthma is a serious global health problem whose prevalence is increasing in most countries, especially among children 1 The global prevalence of asthma ranges from 1% to 18% of the population in different countries 1 The lack of a precise and universally accepted definition of asthma makes reliable comparison of reported prevalence from different parts of the world problematic 1 Childhood asthma has more than doubled in the last 20 years 2 Over the past 40 years, there has been a sharp increase in the prevalence, morbidity, mortality and economic burden associated with asthma, particularly in children 3 Among patients seen in clinical practice up to 60% of paediatric and 30% of adult patients have asthma 3 References Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007 . European lung white book. Brussels, Belgium: European Respiratory Society and the European Lung Foundation, 2003. 3. Braman SS. Chest 2006; 130 : 4S–12S.
- Notes The rate of asthma increases as communities adopt Western lifestyles and become urbanised 1 The most striking increases in asthma are seen in children 2 As the proportion of the world's population that is urban is projected to increase to 59% in 2025, there is likely to be a marked increase in the global prevalence of asthma over the next two decades 1 References 1. Partridge MR. Eur Respir Rev 2007; 16 : 67–72. 2. Braman SS. Chest 2006; 130 : 4S–12S.
- Notes The most striking increases in asthma prevalence are seen among children with rates > 30% in some areas 1 The increase in asthma prevalence has been associated with a rise in atopic sensitization and a parallel increase in other allergic conditions (eg ezcema, rhinitis). Allergic sensitization appears to begin in utero 1 Environmental influences such as exposure to microorganisms, pollutants, indoor and outdoor allergens, and diet exert a strong influence on the development of the disease in susceptible individuals 1 In France, traffic related particulate air pollution contributes to 243,000 attacks of asthma in children alone 2 Two thirds of asthmatic children still have symptoms at age 21, and 5 to 10% of those with “trivial” asthma as children will have severe disease as adults 1 Children account for a high proportion of indirect costs (39%) reflecting the importance of time spent by others to care for them 3 69% of parents of asthmatic children reported having to take time off work and 13% of parents lost their jobs caring for their child’s asthma 1 During infancy, a number of viruses have been associated with the inception of the asthmatic phenotype 4 Infants fed formulas of intact cow’s milk or soy protein have a higher incidence of wheezing illnesses in early childhood compared with those fed breast milk 4 Children consume a high proportion of resources devoted to emergency treatment (45%) 3 School days lost in Australia and USA were 50 x 10 4 and > 1000 x 10 4 respectively 3 References Braman S. Chest 2006; 130 : 4S–12S. European lung white book. Brussels, Belgium: European Respiratory Society and the European Lung Foundation, 2003. Barnes PJ. Eur Respir J 1996; 9 : 636–42. GINA Global Strategy for Asthma Management and Prevention. Revised 2006.
- Notes The Asthma Insights and Reality in Europe study (AIRE) assessed the current levels of asthma control as reported by patients and the extent to which guideline recommendations were being implemented 1 It showed that although the majority of patients considered themselves to have controlled asthma, yet symptom levels showed control failing to reach the levels expected by management guidelines 1 Overall, only 5.3% of all patients (5.1% of adults and 5.8% of children) met all the criteria for asthma control 1 In the AIRLA study, only 2.4% of asthma patients (2.3% of adults and 2.6% of children) surveyed in South America achieved GINA-defined levels of control 2 References 1. Rabe KF et al. Eur Resp J 2000; 16 : 802–807. 2. Neffen H et al. Pan American J Public Health 2005; 17 : 191–197.
- Notes The GINA definition for control of asthma includes no limitation on activities, including exercise However, results from the American Insights and Reality in Latin America (AIRLA) survey showed that activity limitation caused by asthma was considerable in adults and children in Latin American countries In children, symptoms of asthma had the biggest impact on activities such as: Sleeping: 43% Sports and recreation: 42% Normal physical activity: 33% Lifestyle: 33% In addition, 58% of the children with asthma in this study reported that their asthma had caused them to miss school in the last year Reference Neffen H et al. Pan American J Public Health 2005; 17 : 191–197.
- Notes Improved asthma control is reflected by fewer symptoms, less need for reliever medications, and fewer exacerbations 1 It is recommended that treatment be aimed at controlling the clinical features of disease, including lung function abnormalities 1 Overuse of rescue medication is an indication of poor asthma control. GINA defines >2/week use of rescue medication or 2 rescue medication prescriptions per year as suggestive of poor control 1 Studies have shown that as few as 5% of patients meet all of the criteria for guideline-defined control 2 In the AIRLA study, only 2.4% of asthma patients surveyed in South America achieved guideline-defined levels of control 3 References 1. Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007 . 2. Rabe KF et al. Eur Resp J 2000; 16 : 802–807. 3. Neffen H et al. Pan American J Public Health 2005; 17 : 191–197.
- Notes The suggested reliever medication to be taken at each step is also outlined in the updated GINA guidelines, with the preferred controller option show in the shaded box Treatment Steps 2 through 5, combine an as-needed reliever treatment with regular controller treatment At Step 2, a low-dose inhaled glucocorticosteroid (ICS) is recommended as the initial controller treatment for asthma patients of all ages Other options are available but not recommended for routine use as initial or first-line controllers in Step 2. Sustained-release theophylline has only weak anti-inflammatory and controller efficacy and is commonly associated with a wide range of side effects At Step 3, the recommended option for adolescents and adults is to combine a low dose of ICS with an inhaled long-acting 2-agonist, either in a combination inhaler device or as separate components. However, for all children, but particularly those 5 years and younger, combination therapy has been less well studied and the addition of a long-acting 2 -agonist may not be as effective as increasing the dose of ICS in reducing exacerbations. However, the interpretation of some studies is problematic as not all children received concurrent ICSs The preferred treatment at Step 4 is to combine a medium or high dose of ICS with a long-acting inhaled 2 -agonist. However, in most patients, the increase from a medium to a high dose of ICS provides relatively little additional benefit, and the high dose is recommended only on a trial basis for 3 to 6 months when control cannot be achieved with medium-dose ICS combined with a long-acting 2 -agonist and/or a third controller (e.g. leukotriene modifiers or sustained-release theophylline) Reference Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007.
- Notes GINA guidelines recommend i nhaled therapy as the cornerstone of asthma treatment for children of all ages Furthermore, inhaled glucocorticosteroids (ICSs) are the recommended treatment since they are the most effective controller therapy Guidelines are further supported by evidence that oral or systemic glucocorticosteroid use increases the risk of fracture: The risk of fracture increases along with the number of treatments, with a 32% increase at four courses Use of ICSs reduces the need for systemic courses Reference Global Initiative for Asthma (GINA): Global strategy for asthma management and prevention. Revised Edition 2007 .
- Notes The MOSAIC study (Montelukast Study of Asthma in Children) was a 12-month, randomised, non-inferiority study comparing montelukast (MON) 5 mg od with FP 100 µg bd in children aged 6–14 years In this study, patients receiving MON had more exacerbations that those receiving FP (32.2% vs 25.6%), and required more systemic corticosteroids during the treatment period (17.8% vs 10.5%, p≤0.001) Reference Garcia Garcia ML et al . Paediatrics 2005; 116 : 360–369.
- Notes Results from a 12-week, randomised, double-blind study comparing MON 5 mg od with fluticasone propionate (FP) 50 µg bd in children aged 6–12 years demonstrated that at week 12, significantly more patients stated that they were satisfied with treatment in the FP group than in the MON group (58% vs 46%; p=0.006) Compared with MON, FP significantly increased mean percent change from baseline FEV1 (p=0.02), morning PEF (p=0.004), evening PEF (p=0.02) and percentage rescue-free days (p=0.002) In addition, the mean daily total asthma-related cost per patient in the FP group was one-third that of the MON group ($1.25 vs $3.49) Reference Ostrom NK et al. J Pediatr 2005; 147 : 213–220.
- Notes A further study of MON vs FP in children aged 6–14 years compared MON 5–10 mg once a day with FP 100 µg bd showed that asthma control improves consistently and significantly more with FP than with MON: Average asthma control (MON vs FP, adjusted mean values): 5 vs 4.3; p<0.0001 Overall asthma control questionnaire score (MON vs FP, adjusted mean values): 0.59 vs 0.76; p=0.0009 FEV1/FVC (%; MON vs FP, adjusted mean values): 82.2 vs 79.0; p<0.0001 Reference Zeiger RS et al. J Clin Immunol 2006; 117 : 45–52.
- Notes Despite guideline recommendations on asthma therapy, non-steroidal oral medications are widely used first-line for many children regardless of severity or level of control In Latin America, of the 37% of patients who reported taking a prescribed asthma medication to reduce airway inflammation, only 6% were using ICS Prescription data from the USA indicates that many children are prescribed either MON, ICS or SFC first line, the prescription is given regardless of severity or control Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes Asthma morbidity in children remains high, with levels of asthma control falling short of guideline recommendations The PEACE Study compared the efficacy and safety of inhaled SFC with oral MON for the control of persistent asthma in children aged 6–14 years Symptomatic patients (FEV 1 55%–80% predicted normal) were randomised to double-blind, double dummy treatment with SFC 50/100 µg twice daily (N=281) or MON 5 mg once daily (N=267) for 12 weeks Changes from baseline in lung function, asthma symptoms and rescue medication use were assessed Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes A total of 548 patients were randomised to treatment, of which 281 received SFC and 267 recevied MON. The number of patients completing the study was: SFC: 263 (94%) MON 244 (91%) As can be seen from the table, demography and baseline characteristics were similar for the two groups. Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes Over weeks 1–12, the adjusted mean change from baseline in PEF was 45.8 (2.82) L/min in the SFC group and 28.7 (2.86) L/min in the MON group, giving a statistically significant treatment difference in favour of SFC: 17.6 L/min (95% CI: 9.23, 25.08, p<0.001) Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes The SFC group had statistically significant greater improvements in percentage symptom-free and rescue-free 24-hour periods compared with MON: % symptom-free 24-hour periods: p=0.025 % rescue-free 24-hour periods: p <0.001 % nights with no awakenings: p=0.0154 Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes More patients in the SFC group achieved “well controlled” asthma compared with the MON group A week of asthma control was defined as: No night-time awakenings No exacerbations No emergency visits No treatment-related adverse events Having 2 out of 3 of: Symptoms on <3 days Rescue 2 -agonist use on <3 days Daily morning PEF ≥80% predicted Over the whole treatment period, the median percentage of controlled asthma weeks was 83.3% in the SFC group and 66.7% in the MON group (SFC:MON difference 16.7%; 95% CI: 8.3, 16.7; p<0.001 in favour of SFC) Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes In this study, an exacerbation was defined as worsening asthma requiring: Emergency room visit Hospitalisation Unscheduled clinic visit requiring treatment with systemic corticosteroids or nebulised salbutamol >12 puffs per day of salbutamol or >10 puffs per 2 consecutive days of salbutamol Mean exacerbation rates over 12 weeks was 0.12 in the SFC group and 0.30 in the MON group (SFC/MON ratio 0.40; 95% CI: 0.29, 0.57; p<0.001) Significantly fewer patients had at least one exacerbation during treatment with SFC (29; 10.3%) compared with MON (62; 23.2%), giving a significantly lower exacerbation rate This shows that in children with uncontrolled asthma, treatment with SFC is significantly more effective in decreasing exacerbation rates than treatment with MON Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes The most commonly reported adverse event in both groups was headache: SFC: 66/281 (23%) MON: 72/267 (27%) Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes There were four, non drug-related, serious adverse events (SAEs) reported during the study, all in the MON group One SAE, dengue fever, started during the run-in phase The other three were asthma exacerbations, all resulting in hospitalisation Seven patients were withdrawn due to worsening asthma in the MON group, and none in the SFC group No deaths were recorded during the study Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes The PEACE study concludes that in children with uncontrolled asthma, treatment with SFC is significantly more effective in improving measures of asthma control and in decreasing exacerbation rates than treatment with MON, and the two drugs were both well tolerated Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes Compliance may be influenced by: Concern about side effects Patient’s negative attitude towards medicines in general Past experience Views of others Cultural influences Practical difficulties Patient’s perceived need Reference 1. Horne R. Chest 2006; 130 : 65–72.
- Notes In children and adolescents, there is almost 100% self-management of their asthma symptoms 1 The complexity of optimum routine management of asthma results in reduced adherence 1 Adherence to treatment by children and adolescents ranges from 43% to 100%,with an average of 58% in developed countries 2 References 1. Slack MK et al. Am J Health-System Pharmacy 1995; 52 : 1417 – 1421. 2. Burkhart P et al . In: Hayman L, Mahom M,Turner R, eds. Chronic illness in children: An evidence-based approach. New York, Springer, 2002: 199 – 229.
- Notes It has been shown that simple dose regimens are generally easier for patients to follow 1 Compliance rates are most highly correlated with the number of doses rather than the number of medications or tablets that must be taken daily 1 The core issue for patients is: “How many times a day must I remember to take a dose?” 1 Reference 1. Cramer JA. Heart 2002; 88 : 203–206.
- Notes Over one third of children with asthma answering the schools questionnaire had been prescribed an inhaler that was almost certainly unsuitable for their use. Most of these had been prescribed a metered dose inhaler alone 1 Both children and parents overestimated the child’s ability to use their inhaler 1 As small children have smaller inspiratory capacities than adults in terms of both flow rate and volume, DPIs are generally not advocated for children under the age of 6 years. However, Diskus™ operates at low flow rates and has been shown to be effective for use in children aged as young as 4 years 2 All patients could generate adequate flow through the Diskus. However, only 57% could generate adequate flow through the Turbuhaler™ and 21% through the Aerolizer ®2 A further study in children highlighted the problems that some may have to generate sufficient inspiratory effort to receive the required dose from a Turbuhaler and recommended that this device should not be prescribed to preschool age children 2 References 1. Childs F et al. Arch Dis Child 2002; 86 : 176–179. 2. Chrystyn H. Int J Clin Pract 2007; 61 : 1022–1036.
- Notes The aim of this prospective, randomised trial was to directly compare the efficacy and safety of SFC compared with MON in children with persistent uncontrolled asthma, not currently receiving anti-inflammatory treatment Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes Male or female subjects aged 6–14 years, with a diagnosis of asthma for at least 6 months (ATS definition), a forced expiratory volume in one second (FEV 1 ) between 55% and 80% of predicted normal and 12% FEV 1 reversibility, were eligible for the study Subjects required to be symptomatic on short acting 2 agonists and must not have used ICS over the previous month or LTRAs over the previous 2 weeks Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes Prior to randomisation, patients were required to show diary card evidence of either salbutamol rescue use or asthma symptoms on at least 4 out of the last 7 days of the run-in period Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes The primary endpoint was change from baseline in morning peak expiratory flow (PEF) over weeks 1–12, as recorded on daily diary cards. PEF was measured using a Mini Wright Truzone Peak Flow Meter. The highest of three values each morning and evening was recorded, before taking study medication or any as needed salbutamol Secondary efficacy endpoints included pre-dose FEV 1 , evening PEF, level of symptoms and rescue medication use and assessment of asthma control A week of asthma control, as defined in the GOAL study, was defined as no night-time awakenings due to asthma, no exacerbations, no emergency visits, no treatment-related adverse events enforcing a change in asthma therapy, and having 2 out of 3 criteria of: Symptoms (score >1) on less than 3 days Rescue 2 -agonist use on less than 3 days up to a maximum of four occasions per week Morning PEF 80% predicted every day Asthma-specific quality of life was assessed at the start and end of treatment using the Paediatric Asthma Quality of Life Questionnaire (PAQLA) for children and the Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) for the caregivers Questionnaires were only performed in centres where there was a valid translation available. The minimal important difference for both questionnaires is a change in score of 0.5 Reference Maspero J et al. Poster presented at American Thoracic Society International Conference , Toronto, Canada, 16–21 May 2008.
- Notes An 8-week study had previously been carried out to determine the effect of MON compared with placebo, on asthma control, including measurements of airways obstruction, patient-reported end points, and asthma outcomes, as well as to determine the safety profile in 6- to 14-year-old patients with asthma The treatment groups were well matched with respect to baseline demographic and clinical characteristics The median age of the 336 randomized patients was 11 years, and the mean duration of asthma was 7 years. Approximately two-thirds of patients in each treatment group were male. At baseline, 33% of patients in the placebo group and 39% of patients in the MON group used inhaled corticosteroids. The mean FEV 1 was 72% of predicted in each group 1 Reference Knorr B et al. JAMA 1998; 279 : 1181–1186.