A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years

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1 CPSS_ _000C1.ps 8/24/09 8:54 AM Page 3 SUPPLEMENT TO A P E E R - R E V I E W E D J O U R N A L SEPTEMBER 2009 VOL.8 NO.9 FOR PEDIATRICIANS A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years KEVIN R. MURPHY, MD MICHAEL H. MELLON, MD Supported by AstraZeneca LP

2 FACULTY DISCLOSURE Authors Michael H. Mellon, MD Provider Relationship/Manufacturer Speakers Bureau/Consultant: AstraZeneca, Schering-Plough Kevin R. Murphy, MD Speakers Bureau/Consultant: AstraZeneca, Dey, GlaxoSmithKline, Merck, Schering-Plough, Sepracor Research: AstraZeneca, Schering-Plough CONSULTANT FOR PEDIATRICIANS (ISSN ) is published 12 times a year by CMPMedica LLC. It is distributed to over 63,000 physicians, MD and DO, plus nurse practitioners and physician assistants. Subscription rates: $100 a year in the U.S.; $110 a year (U.S. funds only) for Canada and overseas countries (foreign delivery not guaranteed); students, $45 a year; single issues, $10 ($15 foreign). Visa and MasterCard are accepted. Periodicals postage paid at Norwalk, CT 06854, and additional mailing offices. Copyright 2009 by CMPMedica LLC, 535 Connecticut Avenue, Suite 300, Norwalk, CT 06854, (203) Printed in U.S.A. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without written permission. CONSULTANT, What s Your Diagnosis?, What s The Take Home?, and CONSULTANT FOR PEDIATRICIANS are registered trademarks of CMPMedica LLC. The opinions expressed herein are those of the authors and do not necessarily represent those of CONSULTANT FOR PEDIATRICIANS, Scientific Connexions, or AstraZeneca LP. Any procedures or other courses of diagnosis or treatment discussed or suggested by authors should not be used by clinicians without evaluation of their patients conditions and possible contraindications or dangers in use, review of any applicable manufacturer s prescribing information, and comparison with the recommendations of other authorities.

3 KEVIN R. MURPHY, MD Boys Town National Research Hospital, Omaha, Neb MICHAEL H. MELLON, MD Southern California Permanente Medical Group San Diego, Calif A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years Dr Murphy is director of allergy, asthma & pulmonology research at Boys Town National Research Hospital in Omaha, Neb. Dr Mellon is an asthma staff pediatric allergist at Southern California Permanente Medical Group in San Diego, Calif. The authors acknowledge Marissa Buttaro, MPH, and Anny Wu, PharmD, from Scientific Connexions in Newtown, Penn, for writing assistance funded by AstraZeneca LP. ABSTRACT: Diagnosing and treating asthma in preschool-aged children is challenging and requires ongoing monitoring of asthma control. Asthma control reflects the degree to which asthma risks, symptoms, and limitations are minimized and goals of therapy are met. Both clinicians and caregivers have a role in monitoring a child s asthma control. The Test for Respiratory and Asthma Control in Kids (TRACK TM ) is a new validated and easy-to-administer caregiver-completed questionnaire that can be used to aid caregivers and clinicians in evaluating respiratory control in children younger than 5 years with respiratory symptoms consistent with asthma. Asthma is the most prevalent chronic disease in children. 1 In the United States, asthma affects approximately 1.4 million children younger than 5 years 2 and causes frequent activity limitations 3 and hospitalizations. 1,4 Unfortunately, a substantial number of children in this age-group have suboptimal asthma control, demonstrated by the higher rates of emergency department (ED) visits and hospitalizations in preschool-aged children than in older children. 4 In the United States, mothers of children aged 1 to 5 years with persistent weekly asthma-like symptoms (ie, cough, wheeze, breathlessness) have reported that 22% of the children had an ED visit and 11% had been hospitalized within the past 6 months. 5 In 2007, approximately 851,000 children younger than 5 years had an asthma attack in the past year, which represents 61% of the children with asthma in this agegroup. 2 These findings suggest that the treatment goals of asthma are not currently being met in preschoolaged children. The goal of asthma therapy, detailed in the 2007 National Heart, Lung, and Blood Institute and National Asthma Education and Prevention Program s Expert Panel Report 3 (EPR-3), 6 is to control asthma by reducing both the impairment and risk domains. Impairment addresses the daily impact of asthma on traditional clinical indices and quality of life. Risk refers to the negative consequences of the disease or pharmacotherapy. Impairment is reduced by preventing chronic and troublesome symptoms, minimizing short-acting 2 -adrenergic agonist (SABA) use to 2 or fewer days a week, maintaining near-normal pulmonary function, maintaining normal activity levels, and meeting patients and families expectation of and satisfaction with asthma care. Risk is reduced by preventing recurrent exacerbations of asthma and minimizing the need for ED visits or hospitalizations, preventing reduced lung growth, and providing optimal pharmacotherapy with minimal or no adverse events. Both domains may respond differently to treatment. Treatments are selected and adjusted on the basis of the patient s level of asthma control, which is determined by assessments made SEPTEMBER 2009 ASTHMA CONTROL IN CHILDREN S1

4 A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years by the health care provider (HCP) and caregiver. This review provides an overview on how to assess and achieve asthma control in children younger than 5 years and presents answers based on current asthma guidelines to the following questions that arise during clinic visits: Is the diagnosis asthma? Can a child outgrow asthma? How severe is the child s asthma? What are the current recommendations for initial controller or step-up therapy? What is the preferred therapy when initiating daily controller medications? Are the child s respiratory symptoms controlled? What is the Test for Respiratory and Asthma Control in Kids (TRACK TM )? 7 What are the next steps for a child with uncontrolled respiratory symptoms? How can caregivers help children achieve asthma control? S2 ASTHMA CONTROL IN CHILDREN SEPTEMBER 2009 Case Study: Matt Chief complaint. Matt is a 3-year-old boy who presents to the office with his mother because she completed TRACK online (www. asthmatracktest.com), and Matt received a TRACK score of 60. On the basis of what she read, a TRACK score lower than 80 means that Matt s breathing problems may not be under control, whereas a score of 80 or higher would suggest that his symptoms were under control. Therefore, she is worried about her child s breathing. History of present illness. The mother states that Matt was recently seen at an after-hours clinic because he has been coughing more, especially at night, which results in his awakening. He usually is sick after an upper respiratory tract infection (URTI), which almost always goes to his chest, she said. After these episodes, he seems to get out of breath when he runs around too much at the playground. However, between these episodes, he basically is in good health. Past medical history. A review of Matt s chart shows that he was first seen in the office for an acute respiratory infection with wheezing at 7 months of age. Over the past year, he has had 4 sick visits for respiratory complaints with diagnoses of recurrent pneumonia and reactive airway disease. He recently had an urgent care visit and was treated with nebulized albuterol and oral prednisolone for 4 days, which appeared to resolve the episode. Allergies/medications. Matt has no known allergies. He currently uses a jet nebulizer and compressor to deliver albuterol treatments as needed. Matt s mother reports that Matt uses his albuterol medication about once or twice a week, especially during the winter months. Family history. Matt s mother notes that she herself has had asthma since childhood and that Matt s father suffers from sinus allergies in the fall. Physical examination (PE). Remarkable findings upon PE include increased nasal secretions and some mucosal swelling. The lungs are clear. IS THE DIAGNOSIS ASTHMA? When a child presents with frequent or chronic respiratory symptoms (Figure 1), establishing an accurate diagnosis of asthma is the first step to achieving disease control. As many as 50% to 80% of children who have asthma have symptoms before 5 years of age. 6 However, there are several diagnostic challenges in this age-group of children with asthmalike symptoms. First, asthma is a heterogeneous disease with variable presentation in the frequency, type, and severity of symptoms. 6,8 Second, spirometry is recommended for the diagnosis of asthma in children older than 5 years and adults, but is not generally feasible in preschool-aged children. 6 Finally, asthma symptoms are common in childhood respiratory ailments, including recurrent URTIs. Symptoms and physical exam. In preschool-aged children, the diagnosis of asthma is based largely on clinical judgment and the assessment of symptoms and PE. 9 Components of the diagnostic evaluation for this age-group include a detailed medical history; an assessment of the frequency, type, and pattern of symptoms (Table 1); as well as a PE. 6 A patient s medical history allows the HCP to evaluate factors that indicate a likely diagnosis of asthma. Key indicators suggestive of asthma are wheezing, recurrent respiratory symptoms, a history of nighttime cough, symptoms that occur or worsen in the presence of a trigger, and responsiveness to a bronchodilator. Although no one indicator is diagnostic, the presence of multiple indicators increases the probability of an asthma diagnosis. Preschool-aged children with asthma often present with recurrent wheezing associated with a viral infection or complaints of recurrent pneumonia or bronchitis. 10 Some of the physical findings suggestive of asthma include hyperexpansion of the thorax, wheezing on chest auscultation, increased nasal secretions, mucosal swelling, atopic dermatitis, or other allergic manifestations. 6 During the evaluation, HCPs should also consider possible alternative diagnoses and perform appropriate tests, if indicated (Table 2). Some possible alternative diagnoses in infants and children include allergic rhinitis, cystic fibrosis, and

5 Figure 1 Asthma diagnosis, treatment, and maintenance of control in preschoolaged children. A child who presents with frequent respiratory symptoms should be assessed by the health care provider and the appropriate steps should be followed to maintain control of the child s asthma or respiratory symptoms. a An ongoing study is under way to validate the TRACK tool in testretest situations to determine its use at follow-up clinical visits. 7 API, Asthma Predictive Index; mapi, modified Asthma Predictive Index; SABA, shortacting 2 -adrenergic agonist; TRACK, Test for Respiratory and Asthma Control in Kids. Table 1 Sample questions for the diagnosis and initial assessment of asthma a Asthma diagnosis is likely if the parent answers yes to any of the following questions: In the past 12 months... Has your child had a sudden severe episode or recurrent episodes of coughing, wheezing, b chest tightness, or shortness of breath? Has your child had colds that go to the chest or take more than 10 days to get over? Has your child had coughing, wheezing, or shortness of breath during a particular season or time of the year? Has your child had coughing, wheezing, or shortness of breath in certain places or when exposed to certain things (eg, animals, tobacco smoke, perfumes)? Has your child used any medications that help him/her breathe better? How often? Are your child s symptoms relieved when the medications are used? In the past 4 weeks, has your child had coughing, wheezing, or shortness of breath... At night that awakened him/her? Upon awakening? After running, moderate exercise, or other physical activity? a These questions are examples and do not represent a standardized assessment or diagnostic instrument, and the validity and reliability of these questions have not been assessed. b High-pitched whistling sounds when breathing out. From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August SEPTEMBER 2009 ASTHMA CONTROL IN CHILDREN S3

6 A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years Table 2 Differential diagnostic possibilities for asthma Probable diagnosis Upper airway disease Allergic rhinitis Sinusitis Obstructions involving large airways Foreign body in trachea or bronchus Vascular rings or laryngeal webs Laryngotracheomalacia, tracheal stenosis, or bronchostenosis Enlarged lymph nodes or tumor Obstructions involving small airways Obliterative bronchiolitis Cystic fibrosis Bronchopulmonary dysplasia Heart disease Other causes Gastroesophageal reflux Questions and signs and symptoms to aid in diagnosis Does the child have constant or seasonal nasal congestion, runny nose, or postnasal drip without obvious febrile upper respiratory tract infection? Does the child have purulent nasal discharge associated with a cough? Are asymmetric breath sounds present? Did the child present with a sudden onset of cough or choking? Are stridor or inspiratory noises present? Does the child have wheezing associated with feedings? Was the child born prematurely? Consider a laryngoscope or barium swallow with radiograph to confirm a structural abnormality. Are stridor or inspiratory noises present? Are symptoms worse when the child is supine? Is there a history of persisting symptoms of cough and wheezing post pneumonia? Are there persisting crackles and wheezing on examination lasting more than 6 weeks? Does the child have steatorrhea? Is there a history of failure to thrive? Is digital clubbing present? Is there a history of persistent abnormal chest radiographs? Was the child born prematurely? Is there a history of respiratory distress syndrome, surfactant administration, or both? Is there a history of assisted ventilation? Is a heart murmur present? Does the child complain of abdominal pain? Is there a history of frequent spitting up or projectile vomiting as an infant? From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August ,10 S4 ASTHMA CONTROL IN CHILDREN SEPTEMBER 2009

7 gastroesophageal reflux disease. Chest radiographs, pulmonary function tests (in older children), and allergy testing are some of the additional studies that aid in the evaluation of children with recurring symptoms suggestive of asthma. Therapeutic trials. For a child whose medical history, family history, and PE are suggestive of asthma (Figure 1), 7,11 a therapeutic trial of SABA therapy (eg, albuterol), antiinflammatory therapy (eg, inhaled corticosteroid [ICS]), or both clinically helps one decide whether a child has asthma. 9 Observation of symptom improvement after administration of albuterol while the child is in the office or at home during wheezing episodes also assists in establishing the diagnosis. If a SABA alone, administered by nebulizer or metered-dose inhaler (MDI) every 4 to 6 hours, does not control symptoms, the HCP should initiate a short course of an oral corticosteroid (OCS) and observe the effect of this combination on the wheezing. The role of OCSs in the future management of the child s wheezing episodes then should be decided and included in the asthma management plan. For children with persistent asthma, as defined by the impairment or risk domains of the EPR-3, a trial of an ICS is indicated. 6 Response should be monitored carefully for reduction in impairment symptoms, a reduction in the frequency and severity of exacerbations, or both. If there is no clear response to the therapeutic trial within 4 to 6 weeks, adherence to the treatment recommendation and device technique should be evaluated. 6 Alternative diagnoses or adjustment of therapies should be considered if both adherence and technique are satisfactory. Marked clinical improvement during treatment with SABAs and ICSs and a return of symptoms when treatment is stopped support a diagnosis of asthma. 9 CAN A CHILD OUTGROW ASTHMA? The natural history of asthma in children younger than 5 years varies. 6 Two general patterns of illness include the remission of symptoms during preschool years and the persistence of symptoms throughout childhood. The Tucson Children s Respiratory Study followed children from birth and found that of the group who had wheezing before age 3 years, 60% would report no wheezing episodes at 6 years of age. 12 These children, who were called transient infant wheezers, 13,14 did not have a family or personal history of atopy, had symptoms only during the first 3 years of life, 12 and had diminished lung function from birth. 12 The remaining 40% of the children who continued to wheeze into the school-aged years consisted of persistent nonatopic wheezers and, mostly, persistent atopic wheezers. 13 Children with nonatopic wheezing did not have a family or personal history of atopy, but unlike the transient wheezers, their symptoms continued beyond 6 years of age but diminished in preadolescence. 12,13 Children with the persistent atopic wheezing phenotype had atopy and a family history of asthma. These children continued to wheeze throughout the schoolaged years, often without associated viral infections, and represented the usual phenotype of childhood asthma in the 5- to 11-year age-group. The persistence of asthma in a given child cannot be definitively predicted. 6 However, the Asthma Predictive Index (API) was developed to allow one to assess the likelihood that a child with frequent wheezing in the first 3 years of life will experience persistent asthma 6,13,15 so that the child can be monitored and appropriate treatment started. Children with a positive API have a parental history of asthma or physician-diagnosed atopic dermatitis or 2 of the following: physician-diagnosed allergic rhinitis, wheezing apart from colds, or blood eosinophilia of 4% or higher. 14 A retrospective analysis of 1246 patients from the Tucson Children s Respiratory Study showed that the API had a specificity of 97.4%, which is the likelihood that the schoolchildren without asthma from the original cohort would, when looking back at their histories, have had a negative API in their infancy. 14,15 The study also demonstrated a positive predictive value of 76.6%, which is the probability that infants with a positive API would have had active asthma from ages 6 to 13 years, and a negative predictive value of 68.3%, which is the probability that infants with a negative API would not have experienced asthma at school age. In other words, the API was unable to correctly predict approximately 23% of persistent wheezers and 30% of transient wheezers. 14 Nonetheless, the API is currently the only available guide to assist in predicting which infants with frequent wheezing are likely to develop persistent asthma during their school years. 14 Additional ongoing research is focusing on furthering phenotype-based asthma classification and individualizing treatments. 16 HOW SEVERE IS THE CHILD S ASTHMA? Once a diagnosis is made, additional information should be gathered to classify asthma severity, which is the intrinsic intensity of the disease. 6 The initial classification of asthma severity is made before the child is taking long-term control medication. Severity classification is based on the domains of impairment and risk (Figure 2). Children are classified as having intermittent, mild persistent, moderate persistent, or severe persistent asthma on the basis of the assessments of both domains. The assessment of impairment in children younger than 5 years is SEPTEMBER 2009 ASTHMA CONTROL IN CHILDREN S5

8 A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years based on the frequency of symptoms, nighttime awakenings, and reliever use of SABAs, as well as the child s ability to engage in age-appropriate activities. The level of impairment is based on the most severe category in which any feature occurs. Recurrence of symptoms or SABA use more than 2 times a week indicates persistent asthma. Nighttime awakenings and even minor limitations in activities are also indicators of persistent disease in this age-group. Children with minimal or no impairment may have persistent disease depending on their risk domain. Therefore, it is important for HCPs who diagnose intermittent asthma in a child to periodically revaluate the child for frequency and severity of exacerbations. The assessment of risk is based on the frequency of exacerbations. 6 Generally, young children experience about 4 to 6 colds per year, particularly in the fall and winter months. 17 In preschool- and school-aged children, hospitalizations and ED visits for asthma begin to increase every September and peak in the early fall, which is associated with an increase in viral respiratory tract infections. 18,21 For very young children, however, data to link exact frequencies of exacerbations with different levels of asthma severity are inadequate. A preschooler may have exacerbations in the absence of daily symptoms between attacks. A child who has only 1 exacerbation a year may be classified as having intermittent asthma. What is important is that children with intermittent asthma can have severe asthma exacerbations. According to the guidelines, a child with 2 or more exacerbations within 6 months requiring treatment with an OCS, even without symptoms in between, is considered to have persistent asthma. However, this recommendation is based on panel consensus judgment and clinical Figure 2 Classifying asthma severity in children 0 through 4 years of age. The stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs. The level of severity is determined by both impairment and risk. Assess impairment domain by caregiver s recall of previous 2 to 4 weeks. Symptom assessment for longer periods should reflect a global assessment, such as inquiring whether the patient s asthma is better or worse since the last visit. Assign severity to the most severe category in which any feature occurs. At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. For treatment purposes, patients who had 2 or more exacerbations requiring oral corticosteroids in the past 6 months, or 4 or more wheezing episodes in the past year, and who have risk factors for persistent asthma (ie, positive modified Asthma Predictive Index) may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma. From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August S6 ASTHMA CONTROL IN CHILDREN SEPTEMBER 2009

9 experience because the clinical literature addressing the subject was insufficient (Evidence level D). 6 WHAT ARE THE CURRENT RECOMMENDATIONS FOR INITIAL CONTROLLER OR STEP-UP THERAPY? Failure of over-the-counter medications to relieve a child s recurring respiratory symptoms is often the impetus for a visit to the pediatrician s office. 7 Before initiating therapy, it is important for the HCP to determine what medications the child is currently taking and to establish the step of therapy the child is on, based on the 6-step treatment chart of the guidelines (Figure 3). It is also important to assess the need for these medications and whether continued treatment would be beneficial. The child already may be using an inhaled SABA as needed for quick relief of symptoms. 6 The HCP should determine the frequency of inhaled SABA use to assess the need to step up therapy. While the original API was developed to assess the likelihood that a child would experience persistent asthma, a modified API (mapi) was used as an inclusion criterion in the Prevention of Early Asthma in Kids (PEAK) study to examine whether long-term ICS treatment would prevent disease progression in 285 children aged 2 to 3 years at high risk for persistent asthma. 22 The original API was modified because allergic rhinitis is difficult to diagnose in young children and previously conducted studies have shown that early allergic sensitization to milk or eggs are predictors for developing persistent asthma Differences between the mapi and the original API are described in Table A positive mapi requires the child to have at least 1 of 3 major risk factors or 2 of 3 minor risk factors. The PEAK study showed Figure 3 Stepwise approach for managing asthma in children 0 through 4 years of age. The stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs. If an alternative treatment is used and response is inadequate, discontinue the alternative treatment and use the preferred treatment before stepping up. If clear benefit is not observed within 4 to 6 weeks and the patient/family medication technique and adherence are satisfactory, consider adjusting therapy or another diagnosis. Studies in children aged 0 to 4 years are limited. Step 2 is the preferred therapy and is based on evidence from well-designed randomized controlled trials. All other recommendations are based on expert opinion and extrapolation from studies in older children. Alphabetical order is used when more than 1 treatment option is listed within either the preferred or the alternative therapy. SABA, inhaled short-acting 2 -adrenergic agonist; PRN, as needed; ICS, inhaled corticosteroid; LABA, long-acting 2 -adrenergic agonist. From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August SEPTEMBER 2009 ASTHMA CONTROL IN CHILDREN S7

10 A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years that children with the phenotype of a positive mapi who received fluticasone propionate 88 µg twice daily had a significantly greater proportion of episode-free days (P =.006) and reduction in exacerbations requiring systemic corticosteroids (P <.001) compared with children who received placebo over the 2-year treatment period. 26 The children were followed for 1 year after treatment was discontinued. Findings from the treatment-free year did not support a disease-altering effect after ICS discontinuation. Nevertheless, the outcome of the PEAK trial led to the guideline recommendation that a long-term daily controller (ICS) be initiated for reducing risk and impairment in children younger than 5 years who have had 4 or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep and who have risk factors for developing persistent asthma based on the mapi. 6,26 Many children have intermittent episodes of viral-induced wheezing, and the PEAK trial helps define which of those children with recurrent episodes will benefit from maintenance therapy. A daily long-term controller also should be considered for children with impairment (eg, persistent symptoms) or risk as outlined in Table 4. Moreover, the guidelines recommend a stepwise treatment approach to maintain long-term asthma control (Figure 3). 6 Daily controller therapy is recommended for persistent disease. An ICS is the preferred step 2 controller. A step up in therapy is warranted if asthma control is inadequate and a step down in therapy is recommended to achieve control with the minimal necessary amount of medication. A step down in therapy, with an ICS dose reduction of 25% to 50%, should be considered whenever the child s asthma has been well controlled for 3 or more months. WHAT IS THE PREFERRED THERAPY WHEN INITIATING DAILY CONTROLLER MEDICATIONS? ICS therapy. A low-dose daily ICS is the preferred therapy when initiating daily controller treatment. 6 Many clinical trials with ICSs have enrolled patients 12 years or older. The generalizability of these results to younger children has not been clearly established. However, a recent meta-analysis of 29 studies in infants and preschoolers aged 1 month to 5 years who received an ICS showed that in 2805 children from 16 studies, those who received an ICS had significantly fewer wheezing/ asthma exacerbations (18.0%) than those who received placebo (32.1%; relative risk: 0.59; 95% confidence Table 3 Differences between the mapi 22 and the API 15 Classification of a child as positive mapi or API The child must have a history of 4 wheezing episodes with 1 episode confirmed by a physician and at least 1 major criterion or 2 minor criteria: mapi: Major criteria Original API: Major criteria Parental history of asthma Parental history of asthma Physician-diagnosed atopic dermatitis Physician-diagnosed atopic dermatitis Allergic sensitization to 1 aeroallergen mapi: Minor criteria Original API: Minor criteria Allergic sensitization to milk, egg, or peanuts Physician-diagnosed allergic rhinitis Wheezing unrelated to colds Wheezing unrelated to colds Blood eosinophils 4% Blood eosinophils 4% Use of mapi vs API mapi Identify children with likelihood of benefiting from long-term controller therapy Original API Assess likelihood that children with frequent wheezing in the first 3 years of life will continue to report asthma symptoms at least once from ages 6 to 13 years mapi, modified Asthma Predictive Index; API, Asthma Predictive Index. Adapted from J Allergy Clin Immunol. 2004, Vol Guilbert TW, Morgan WJ, Zeiger RS, et al. Atopic characteristics of children with recurrent wheezing at high risk for the development of childhood asthma. Pages Copyright 2004, with permission from Elsevier. 25 S8 ASTHMA CONTROL IN CHILDREN SEPTEMBER 2009

11 interval: ; P =.0001). 27 Moreover, children on an ICS used significantly less albuterol and had significantly greater mean improvements from baseline in symptoms score, forced expiratory volume in 1 second, and peak expiratory flow (P =.0001). FDA-approved ICSs for the treatment of asthma in young children are limited. Budesonide inhalation suspension administered with a jet nebulizer compressor is approved for children aged 12 months to 8 years, has been shown to be efficacious and tolerable in this agegroup, 28 and is the only ICS indicated for use in children 3 years or younger. 6 Several other combinations of ICSs and delivery devices are available for use in infants and young children, with approval by the FDA down to 4 years of age for mometasone furoate inhalation powder and fluticasone propionate hydrofluoroalkane inhalation aerosol. Moreover, the National Asthma Education and Prevention Program does provide dosage recommendations for the use of fluticasone propionate MDI for children aged 0 to 4 years. 6 Use of fluticasone MDI with a valved spacer and a face mask was studied in the PEAK trial, which showed that low-dose daily ICS therapy is not a disease modifier but does decrease exacerbations and symptom burden in preschoolaged children with risk factors based on the mapi while the child is on treatment. 26 Montelukast. An alternative approved option for this age-group is the orally administered leukotriene receptor antagonist montelukast. 6 A double-blind, randomized study of 689 children aged 2 to 5 years with asthma showed that montelukast treatment over 12 weeks is significantly more effective than placebo in improving daytime asthma symptoms, the percentage of days with asthma symptoms, and the need for a Table 4 National Asthma Education and Prevention Program s guidelines for the initiation of long-term control therapy in infants and children aged 0 through 4 years Recommended for reducing impairment and risk of exacerbations in those who had 4 episodes of wheezing in the past year that lasted >1 day and affected sleep or who have a positive mapi a (Evidence A) Should be considered for reducing impairment in those who consistently require symptomatic treatment > 2 days per week for a period of > 4 weeks (Evidence D) Should be considered for reducing risk in those who have 2 exacerbations requiring systemic corticosteroids within 6 months (Evidence D) May be considered for use only during periods, or seasons, of previously documented risk for a child (Evidence D) a modified Asthma Predictive Index; see Table 3. Evidence A, well-designed randomized controlled trials (RCTs), rich body of data. Evidence D, panel consensus judgment, based on clinical experience or knowledge; clinical literature addressing the subject was insufficient to justify placement in Evidence Categories A through C. From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August ,10 rescue SABA or OCS (P.012). 6,29 Montelukast also has been shown to be effective in reducing asthma exacerbations in children aged 2 to 5 years (N = 549) with viral-associated intermittent asthma. 30 In school-aged children, studies show the effectiveness of ICSs to be greater than that of montelukast. 6,31-33 Therefore, while both ICS and montelukast are effective, an ICS is the preferred longterm daily controller medication in preschool-aged children. 6 Cromolyn. Cromolyn is available as an MDI and as a nebulizer solution, and is currently approved for use in children 2 years and older. 6 However, the symptom benefits of cromolyn in preschool-aged children are inconsistent. 34 According to current guidelines, cromolyn is to be used as an alternative, but not preferred, treatment at step 2 of care. If adequate asthma control is not achieved and maintained after 4 to 6 weeks, the preferred medication should be tried before stepping up therapy. 6 Case Study: What Is Next for Matt? Assessment: Poorly controlled asthma. The HCP classifies Matt as having a positive API because he had 4 episodes of wheezing in the previous year with at least the most recent episode confirmed by a physician and because his mother has had asthma since childhood. On the basis of the findings from the Tucson Children s Respiratory Study, the HCP informs Matt s mother that there is an approximately 75% chance that Matt will have active asthma when he is between the ages of 6 and 13 years. Although Matt has been coughing more at night recently, his symptoms occur 2 or fewer days a week, do not usually interfere with his daily activities, and require use of albuterol 2 or fewer days a week. Despite minimal impairment, Matt s level of risk based on the number of wheezing episodes in the 12 months preceding this visit and positive mapi classify SEPTEMBER 2009 ASTHMA CONTROL IN CHILDREN S9

12 A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years him as a child with persistent asthma. Moreover, because of his risk level and positive mapi, Matt meets the recommendation for a long-term controller medication, which is an increase from his current step 1 therapy (as-needed albuterol) to step 2 therapy. Plan: Daily ICS therapy. The HCP prescribes a low-dose nebulized ICS to use once daily. This therapy is chosen because Matt appears comfortable using a nebulizer, on the basis of his home experience, while his technique with an MDI and valved holding chamber and mask appears to need further practice. An office staff member reviews the proper device technique for a nebulized ICS and ensures that Matt s mother has the proper nebulizer cup, tubing, and mask. Matt s mother is given a written asthma management plan that lists the specific symptoms that indicate Matt s asthma is getting worse; outlines when albuterol should be given; states when it is necessary to increase therapy, including the possibility of the use of an OCS; and states when to seek urgent medical care. In 4 weeks, Matt will return for a follow-up visit and the HCP will assess whether Matt s asthma is adequately controlled. ARE THE CHILD S RESPIRATORY SYMPTOMS CONTROLLED? Similar to asthma severity, asthma control is defined in terms of reducing impairment and risk (Figure 4). 6 In contrast to severity, asthma control reflects the degree to which asthma risks, symptoms, and limitations are minimized and goals of therapy are met. Asthma control becomes the emphasis for clinical management once therapy is initiated. Decisions to maintain or adjust therapy are based on the child s level of asthma control. S10 ASTHMA CONTROL IN CHILDREN SEPTEMBER 2009 The guidelines recommend periodic assessment and monitoring of asthma control at 1- to 6-month intervals. 6 The frequency of HCP visits depends on the patient s level of asthma control and is based mainly on clinical judgment. As previously discussed, for children receiving a therapeutic trial of asthma medication, control should be assessed within 4 to 6 weeks of therapy initiation. Generally, children with intermittent or mild persistent asthma that has been controlled for 3 months or more should see their HCP every 6 months. Children with uncontrolled asthma, severe persistent asthma, or difficulty in following a treatment plan should see a physician more frequently. If step-down therapy is anticipated, the guidelines recommend a 3-month follow-up interval. The primary methods of monitoring asthma control in children are self-assessments filled out by a parent or family member and evaluation by the HCP. The use of self-assessment tools, such as patient diaries or standardized questionnaires, is encouraged to obtain the family s perspective on the child s asthma control. 6 However, currently available asthma control tools were not specifically designed for very young children. Instruments to assess asthma control have been developed for children aged 4 to 11 years, 35 children and adolescents aged 5 to or 1 to 18 years, 37 and adults All of these tools were developed before the guidelines recommended the use of the risk domain for assessment of asthma control. In addition, no tool was specifically designed and validated for use by caregivers of children younger than 5 years who have respiratory symptoms consistent with asthma symptoms. For school-aged children, parents and children s perceptions of asthma symptoms or severity can differ. 42,43 Nonetheless, a caregiver proxy for symptom assessment is necessary in younger children who are not able to complete a questionnaire. WHAT IS THE TEST FOR RESPIRATORY AND ASTHMA CONTROL IN KIDS (TRACK TM )? Recently, TRACK (Figure 5) was developed and validated for caregivers of children younger than 5 years with 2 or more episodes of respiratory symptoms (eg, cough, wheeze, shortness of breath) that lasted 24 hours or more and with either physician-diagnosed asthma or bronchodilator use. 7 In contrast to other validated tools, the TRACK tool encompasses both the risk and impairment domains of respiratory control consistent with current guidelines. 6,7 This tool helps to identify the children with chronic respiratory symptoms consistent with asthma symptoms who would likely be classified as having uncontrolled asthma by an HCP. The TRACK tool was specifically designed for preschool-aged children through a qualitative and quantitative research process. 7 Interviews were conducted with pediatric asthma specialists, pediatricians, and caregivers of young children with recurrent respiratory problems or asthma. On the basis of their feedback, a set of possible test questions about the frequency and severity of respiratory symptoms, the effect of these symptoms on the child s life, and health care utilization was developed. The final TRACK tool comprises 5 questions that best discriminate between the guidelines-based controlled and uncontrolled asthma ratings and that have the greatest predictive value. The TRACK tool includes 4 impairment questions: 3 about the frequency of respiratory symptoms, activity limitations, and nighttime awakenings in the past 4 weeks, and 1 about rescue medication use in the

13 past 3 months. 7 It also includes 1 riskrelated question about OCS use in the previous year. Each question is scored from 0 to 20 points, for a total score between 0 and 100 points. Higher scores indicate better respiratory control. A TRACK score lower than 80 suggests uncontrolled asthma and may be an indication that HCPs need to provide further evaluation and possibly adjust treatment plans. A TRACK score of 80 or more suggests that the child s breathing problems are controlled. The TRACK instrument is not a diagnostic tool but is a brief, caregiver-completed, standardized instrument that is easily administered and scored and can be used for collecting basic information about respiratory and asthma control. 7 It increases caregiver and HCP awareness of potential respiratory control problems in young children. However, the role Figure 4 Assessing asthma control and adjusting therapy in children 0 through 4 years of age. The stepwise approach is meant to assist, not replace, the clinical decision making required to meet individual patient needs. The level of control is based on the most severe impairment or risk category. Assess impairment domain by caregiver s recall of previous 2 to 4 weeks. Symptom assessment for longer periods should reflect global assessment, such as inquiring whether the patient s asthma is better or worse since the last visit. At present, there are inadequate data to correspond with frequencies of exacerbations with different levels of asthma control. In general, more frequent and intense exacerbations (requiring urgent, unscheduled care, hospitalization, or intensive care unit admission) indicate poorer disease control. For treatment purposes, patients who had 2 or more exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have not-well-controlled asthma, even in the absence of impairment levels consistent with not-well-controlled asthma. Before stepping up therapy, review adherence to medications, inhaler technique, and environmental control. If alternative treatment option was used in a step, discontinue it and use preferred treatment for that step. From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August SEPTEMBER 2009 ASTHMA CONTROL IN CHILDREN S11

14 CPSS_ _00012.ps 8/24/09 9:25 AM Page 12 A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years Figure 5 The Test for Respiratory and Asthma Control in Kids (TRACK ). The TRACK tool is a 5-item standardized questionnaire for caregivers of children younger than 5 years. The TRACK tool addresses both the risk and impairment domains of respiratory control, consistent with current asthma guidelines. S12 ASTHMA CONTROL IN CHILDREN SEPTEMBER 2009

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16 A Guide to Monitoring and Achieving Asthma Control in Children Younger Than 5 Years of TRACK in clinical practice and research has not yet clearly been established. An ongoing study is under way to validate the TRACK tool in test-retest situations to determine its use at follow-up clinical visits. Caregivers should base the answers of all 5 TRACK questions on their own interpretation and not seek the opinion of an HCP while answering the questions. In addition, caregivers may be able to complete TRACK either in the waiting room or examination room, although check-in time is ideal. Caregivers also may access the tool online ( and complete it at home. The completion of TRACK before seeing the HCP allows for more in-depth and focused caregiver-provider discussions. The TRACK score can help to facilitate dialogue between the caregiver and the HCP to identify strategies to better manage the child s respiratory symptoms. HCPs should not depend solely on a caregiver s assessment of the child s asthma control because families may be accustomed to their children s asthma symptoms and report good control even for very symptomatic children. 44 In addition to considering the caregiver s assessment of asthma control, the clinician s assessment of asthma control should be obtained through the patient s medical history. Questions should focus on the child s signs and symptoms of asthma, level of activity, and exacerbation history. 6 Table 5 provides sample questions for HCPs to assess and monitor asthma control. 6 In addition, the HCP should review the child s TRACK score and help the caregiver interpret the score, allowing for a specific discussion of the child s level of respiratory and asthma control based on the guidelines (Figure 4). The child s quality of life and satisfaction with treatment should also be reviewed. HCPs should also be aware of some of the external factors that can affect asthma control. A cross-sectional study of 362 children aged 5 to 12 years with asthma who had experienced an acute exacerbation in the past year assessed demographic, family, and pediatric practice characteristics as predictors of asthma control. 45 Factors associated with poor asthma control were Medicaid insurance, full-time or part-time maternal employment, and the presence of another family member in the home with asthma. The authors Table 5 Sample questions for assessing and monitoring asthma control Has your child s asthma awakened him/her at night or early morning? Has your child needed any urgent medical care for his/her asthma, such as unscheduled visits to the doctor, an urgent care clinic, or the emergency department? Has your child needed more quick-relief bronchodilator medication (inhaled short-acting 2 -adrenergic agonist) than usual? Has your child had symptoms while playing? Is your child participating in his/her usual and desired activities? How many days have you had to change your activity because of your child s asthma? From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August S14 ASTHMA CONTROL IN CHILDREN SEPTEMBER 2009 suggested that economic factors and a caregiver s job responsibilities may interfere with the caregiver s knowledge of the child s adherence to medication and level of asthma control. Although extrapolation to preschool-aged children cannot be made directly, the study suggests that the social history may affect asthma control. WHAT ARE THE NEXT STEPS FOR A CHILD WITH UNCONTROLLED RESPIRATORY SYMPTOMS? The HCP should consider coexisting conditions, incorrect diagnosis, new or increased exposures to allergens or irritants, and psychosocial problems that could contribute to suboptimal asthma or respiratory control. 6 In children with asthma, inhalant allergens can increase airway inflammation and symptoms. Consequently, reducing a child s exposure to such allergens can significantly reduce asthma symptoms and the need for medications. The HCP should question caregivers on the child s exposure to allergens such as those associated with pets, mold, moisture or dampness, dust mites, tobacco smoke, unvented stoves or heaters, and medication sensitivities. By using the medical history and skin testing or in vitro testing, with the help of a pediatric allergist, the child s specific allergen sensitivities can be determined. Methods to control asthma by reducing the child s exposure to environmental allergens include removing the pet from the house or, at minimum, keeping the pet out of the child s bedroom, minimizing the child s exposure to tobacco smoke, and closing the windows during periods of peak pollen levels. Aerobiology varies with the region, and molds such as Alternaria are major seasonal causes of asthma in many parts of the United States.

17 In addition, the evaluation and treatment of comorbidities such as obesity and gastroesophageal reflux disease are important because these comorbidities represent independent risk factors that can increase the severity of childhood asthma and cause poor response to treatment. Assessment of what asthma medications the child is taking and adherence to those medications is also a key component to assessing control. As previously discussed, the HCP should determine whether the child is taking any medications for his/her asthma. If the child is, inquire about dosing; inhaler or nebulizer techniques, if appropriate; and adherence by discussing the child s normal daily routine (Table 6). Consultation with an asthma specialist is recommended for children who need step 3 care or higher and should be considered for those who need step 2 care (Figure 3). Table 6 Key questions for monitoring pharmacotherapy and assessing medication adherence What medicines is your child currently taking? How often? How much? How many times a week does the child miss taking the medication? How do you feel about giving your child medicines? Who is responsible for administering the child s medicine? Have you had trouble filling the prescriptions (eg, no prescription insurance or not a covered medicine, pharmacy out of stock)? What problems have you/your child had giving/taking the medicine (eg, cost, time, lack of perceived need)? How many times has your child had to use rescue medicine in the past month? Have you tried any other medicines or remedies for your child? What concerns do you have about your child s asthma medicines? Has the medicine caused any problems for your child (eg, shakiness, nervousness, bad taste, sore throat, cough, upset stomach, hoarseness, bruising)? Please show me how your child uses his or her nebulizer and/or inhaler. From National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Full Report August HOW CAN CAREGIVERS HELP CHILDREN ACHIEVE ASTHMA CONTROL? To facilitate asthma control, a detailed written asthma management plan should be provided to caregivers of children with either intermittent or persistent asthma. A plan is especially important for children with intermittent disease and a history of exacerbations because these patients can experience sudden and life-threatening exacerbations. 6 The action plan should include specific symptoms indicative of worsening asthma, recommendations for SABA and OCS use, and when to seek medical care. Once asthma is diagnosed in a child, asthma self-management education should be initiated and continued throughout the child s asthma care. Asthma self-management education provides patients and caregivers with the skills necessary to control asthma and improve symptoms. 6 The goals of therapy should be established between the caregiver and the HCP. Caregivers should be educated on how medications work and on proper device technique. Addressing caregivers concerns and encouraging treatment adherence are important because caregivers play a major role in establishing and ensuring that the child s asthma is controlled. After each HCP visit, it is also important for the caregiver to schedule a follow-up visit to continually ensure that the child s asthma is well controlled (Figure 1). The caregiver should ensure that a written asthma action plan is in place at all times and should review it with the HCP at each follow-up visit to determine whether any adjustment to the plan is necessary. 6 Caregivers should also note any changes in the severity or frequency of the child s asthma symptoms, especially if wheezing occurs in the absence of a cold or with exercise, and should seek the HCP s advice if such changes are observed. Case Study: Follow-up After 4 weeks, Matt returns to the HCP s office for a follow-up visit. According to Matt s mother, his symptoms seem to be controlled. He has had symptoms of coughing and wheezing only once since his last visit and has not required any oral corticosteroids. Matt is sleeping through the night and has been taking his medications as prescribed. His mother reports that he has needed to use his albuterol only once in the past 2 weeks. Matt s PE results are normal. The HCP determines that Matt s asthma is well controlled (Figure 4) and continues to prescribe a nebulized ICS. The HCP reviews the written action plan with Matt and his mother, reviews device technique, and schedules a follow-up appointment in 3 months to review asthma control and medication requirements. Referral is made to the pediatric allergist for definitive allergy testing and collaborative consultation on longterm management. SEPTEMBER 2009 ASTHMA CONTROL IN CHILDREN S15