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Brief Summary

GUIDELINE TITLE

Managing asthma long term in children 0-4 years of age and 5-11 years of age: Expert panel report 3: guidelines for the diagnosis and management of asthma.

BIBLIOGRAPHIC SOURCE(S)

  • Managing asthma long term in children 0-4 years of age and 5-11 years of age. In: National Asthma Education and Prevention Program (NAEPP). Expert panel report 3: guidelines for the diagnosis and management of asthma. Bethesda (MD): National Heart, Lung, and Blood Institute; 2007 Aug. p. 281-325. [84 references]

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: National Asthma Education and Prevention Program Expert Panel Report: guidelines for the diagnosis and management of asthma update on selected topics-2002. J Allergy Clin Immunol 2002 Nov;110(5 pt 2):S141-219.

BRIEF SUMMARY CONTENT

 
RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Definitions of the levels of the evidence (A, B, C, D) and strength of recommendations ("is recommended" and "should or may, be considered") are presented at the end of the "Major Recommendations" field.

Note from the National Asthma Education and Prevention Program (NAEPP): Panel members only included ranking of evidence for recommendations they made based on the scientific literature in the current evidence review. They did not assign evidence rankings to recommendations pulled through from the Expert Panel Report (EPR)—2 1997 on topics that are still important to the diagnosis and management of asthma but for which there was little new published literature. These "pull through" recommendations are designated by EPR—2 1997 in parentheses following the first mention of the recommendation.

Note from the NAEPP and the National Guideline Clearinghouse (NGC): The Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma have been divided into individual summaries covering assessment, education, medications, and management. In addition to the current summary, the following are available:

Key Points: Managing Asthma Long Term in Children 0-4 Years of Age and 5 – 11 Years of Age

  • The goal for therapy is to control asthma by (Evidence A):
    • Reducing impairment
      • Prevent chronic and troublesome symptoms (e.g., coughing or breathlessness in the daytime, in the night, or after exertion)
      • Require infrequent use (<2 days a week) of inhaled short-acting beta2-agonist (SABA) for quick relief of symptoms (not including prevention of exercise-induced bronchospasm [EIB])
      • Maintain (near) normal pulmonary function
      • Maintain normal activity levels (including exercise and other physical activity and attendance at work or school)
      • Meet patients' and families' expectations of and satisfaction with asthma care
    • Reducing risk
      • Prevent recurrent exacerbations of asthma and minimize the need for emergency department (ED) visits or hospitalizations
      • Prevent progressive loss of lung function; for children, prevent reduced lung growth
      • Provide optimal pharmacotherapy with minimal or no adverse effects
  • A stepwise approach to pharmacologic therapy is recommended to gain and maintain control of asthma in both the impairment and risk domains (Evidence A):
    • The type, amount, and scheduling of medication is dictated by asthma severity for initiating therapy and the level of asthma control for adjusting therapy (Evidence A).
    • Step-down therapy is essential to identify the minimum medication necessary to maintain control (Evidence D).
  • Monitoring and follow up is essential (Evidence B).
    • When initiating therapy, monitor at 2- to 6-week intervals to ensure that asthma control is achieved (Evidence D).
    • Regular follow up contacts at 1- to 6-month intervals, depending on level of control, are recommended to ensure that control is maintained and the appropriate adjustments in therapy are made: step up if necessary or step down if possible. Consider 3-month intervals if a step down in therapy is anticipated (Evidence D).
  • Because asthma is a chronic inflammatory disorder of the airway, persistent asthma is most effectively controlled with daily long-term control medication directed toward suppression of airway inflammation (Evidence A).
  • Therapeutic strategies should be considered in concert with clinician-patient partnership strategies; education of patients is essential for achieving optimal pharmacologic therapy (Evidence A).
  • At each step, patients should be advised to avoid or control allergens (Evidence A), irritants, or comorbid conditions that make the patient's asthma worse (Evidence B).
  • A written asthma action plan detailing for the individual patient the daily management (medications and environmental control strategies) and how to recognize and handle worsening asthma is recommended for all patients; it is particularly recommended for patients who have moderate or severe asthma, a history of severe exacerbations, or poorly controlled asthma (Evidence B). The written asthma action plan can be either symptom or peak-flow based; evidence shows similar benefits for each (Evidence B).
  • Referral to an asthma specialist for consultation or co management of the patient is recommended if there are difficulties achieving or maintaining control of asthma; if additional education is needed to improve adherence; if the patient requires step 4 care or higher (step 3 care or higher for children 0 to 4 years of age); or if the patient has had an exacerbation requiring hospitalization. Consider referral if a patient requires step 3 care (step 2 care for children 0 to 4 years of age) or if additional testing for the role of allergy is indicated (Evidence D)

Key Differences from the 1997 and 2002 Expert Panel Reports

  • Recommendations for managing asthma in children 0 to 4 and 5 to 11 years of age are presented separately from recommendations for managing asthma in youths >12 years of age and adults.
  • Treatment decisions for initiating long-term control therapy are based on classifying severity (considering both the impairment and risk domains) and selecting a corresponding step for treatment. Recommendations on when to initiate therapy in children 0 to 4 years of age have been revised.
  • Treatment decisions for adjusting therapy and maintaining control are based on assessing the level of asthma control (considering both the impairment and risk domains).
  • The distinction between the domains of impairment and risk for assessing asthma control and guiding decisions for therapy emphasizes the need to consider separately asthma's effects on quality of life and functional capacity on an ongoing basis (i.e., in the present) and the risks it presents for adverse events in the future, such as exacerbations and progressive reduction in lung growth or lung function. These domains of asthma may respond differentially to treatment.
  • Stepwise approach to managing asthma has been expanded to include six steps of care to simplify the actions within each step. For example, previous guidelines had several progressive actions within step 3, whereas the current guidelines separate the actions into different steps.
  • Treatment options within the steps have been revised, especially:
    • For patients not well controlled on low-dose inhaled corticosteroid (ICS), increasing the dose of ICSs to medium dose is recommended before adding adjunctive therapy in the 0 to 4 years age group; for other age groups (children 5 to 11 years of age and youths ≥12 years of age and adults), increasing the dose of ICS to medium dose or adding adjunctive therapy to a low dose of ICS are considered as equal options.
    • Evidence for the selection of adjunctive therapy is limited in children under 12 years of age; recommendations vary according to the assessment of impairment or risk.
    • Steps 5–6 for youths >12 years of age and adults include consideration of omalizumab.
  • Managing special situations has been expanded to include racial and ethnic disparities.

Diagnosis and Prognosis of Asthma in Children

Diagnosis of Asthma

0 to 4 Years of Age: The Expert Panel recommends that essential elements in the evaluation include the history, symptoms, physical examination, and assessment of quality of life, as discussed in the NGC summary of the NAEPP guideline, Measures of Asthma Assessment and Monitoring. A therapeutic trial with medications listed in figure 4–1a in the original guideline document will also aid in the diagnosis.

5 to 11 Years of Age: The Expert Panel recommends that the diagnosis in children 5 years of age and older should follow the same procedures recommended in the NGC summary of the NAEPP guideline, Measures of Asthma Assessment and Monitoring.

Prevention of Asthma Progression

The Expert Panel concludes that evidence to date does not support the previously hypothesized contention that early intervention with an ICS, either continuously ("Long-term effects," 2000; Guilbert et al., 2006) or intermittently (Bisgaard & Szefler, 2006), may alter the underlying severity or progression of the disease. ICSs should be used to control asthma symptoms and to improve the child's quality of life, but their use should not be initiated or prolonged for the purpose of changing the natural history of the disease (i.e., the underlying severity or progression of asthma) (Evidence A).

Monitoring Asthma Progression

The Expert Panel recommends that the following measures be monitored over the course of children's followup visits, especially in those children who have moderate or severe persistent asthma (require Step 3 care or higher), to assess both impairment and risk domains for the development of progressive disease: course of medications, including increasing use of SABAs and escalation of long-term control medications; episodes of severe exacerbations requiring systemic corticosteroids, urgent care visits, or hospitalizations; pulmonary function measures including prebronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) and FEV1 (percent predicted) and postbronchodilator FEV1 (percent predicted) (Evidence B). If these measures so indicate, therapy should be stepped up to ensure adequate asthma control. See box 4–1 in the original guideline document for a sample patient record for monitoring asthma progression in children.

Treatment: Principles of Stepwise Therapy in Children

The Expert Panel recommends that the goal of asthma therapy is to maintain long-term control of asthma with the least amount of medication and hence minimal risk for adverse effects. Control of asthma may be viewed in the context of two domains—impairment and risk—and within these domains, defined as follows (Evidence A).

  • Reducing impairment
    • Prevent chronic and troublesome symptoms (e.g., coughing or breathlessness in the daytime, in the night, or after exertion)
    • Require infrequent use (<2 days a week) of SABA for quick relief of symptoms (not including prevention of EIB)
    • Maintain (near) normal pulmonary function
    • Maintain normal activity levels (including exercise and other physical activity and attendance at work or school)
    • Meet patients' and families' expectations of and satisfaction with asthma care
  • Reducing risk
    • Prevent recurrent exacerbations of asthma and minimize the need for ED visits or hospitalizations
    • Prevent progressive loss of lung function; for children, prevent reduced lung growth
    • Provide optimal pharmacotherapy with minimal or no adverse effects

The Expert Panel recommends that the stepwise approach to therapy, in which the dose and number of medications and frequency of administration are increased as necessary (Evidence B, extrapolated from studies in older children and adults) and decreased when possible (Evidence D), is used to achieve and maintain this control.

Achieving Control of Asthma

Selecting Initial Therapy

0 to 4 Years of Age: Initiating Long-Term Control Therapy

The Expert Panel concludes that initiating daily long-term control therapy:

  • Is recommended for reducing impairment and risk of exacerbations in infants and young children who had four 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: either (1) one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens OR (2) two of the following: evidence of sensitization to foods, >4 percent peripheral blood eosinophilia, or wheezing apart from colds (Evidence A).
  • Should be considered for reducing impairment in infants and young children who consistently require symptomatic treatment more than 2 days per week for a period of more than 4 weeks (Evidence D).
  • Should be considered for reducing risk in infants and young children who have a second asthma exacerbation requiring systemic corticosteroids within 6 months (Evidence D).
  • May be considered for use only during periods of previously documented risk for a child (Evidence D). If daily long-term control therapy is discontinued after the season of increased risk, written asthma action plans indicating specific signs of worsening asthma and actions to take should be reviewed with the caregivers, and a clinic contact should be scheduled 2 to 6 weeks after discontinuation of therapy to ascertain whether adequate control is maintained satisfactorily (Evidence D).

5 to 11 Years of Age: Initiating Long-Term Control Therapy

The Expert Panel recommends daily long-term control therapy for children who have persistent asthma (Evidence A).

Adjusting Therapy

The Expert Panel recommends that, if a child is already taking long-term control medication, treatment decisions are based on the level of asthma control that has been achieved: therapy should be stepped up if necessary to achieve control (Evidence B—extrapolated from studies in youths and adults) (See figures 4–3a and 4–3b in the original guideline document).

  • Address the impairment domain. Consider factors related to the different age groups.
    • 0 to 4 years of age: The level of impairment generally is judged on the most severe symptom. The risk domain is usually more strongly associated with asthma morbidity than the impairment domain, because children are often symptom free between exacerbations.
    • 5 to 11 years of age: The level of impairment generally is judged on the most severe measure among symptom report, asthma control score (using validated tools if available), and pulmonary function measures. For patients at step 3 or higher care, if office spirometry is feasible and suggests poorer control than does the assessment of impairment based on other measures, consider fixed airway obstruction as the explanation and reassess the other measures of impairment. If fixed airway obstruction does not appear to be the explanation, consider a step up in therapy, because low FEV1 is a predictor of risk for exacerbations in children. (See the NGC summary of the NAEPP guideline, Measures of Asthma Assessment and Monitoring.)
    • The Expert Panel recommends the following actions if control of the impairment domain is not achieved and maintained at any step of care:
      • Patient adherence and technique in using medications correctly should be assessed and addressed as appropriate (Evidence C). See the NGC summary of the NAEPP guideline, Education for a Partnership in Asthma Care, for discussion on assessing adherence.
      • Other factors that diminish control of asthma impairment should be addressed as possible reasons for poor response to therapy and targets for intervention (Evidence C).
      • If patient adherence, inhaler technique, and environmental control measures are adequate, and asthma is not well controlled, a step up in treatment may be needed (Evidence B—extrapolated). For patients who have asthma that is not well controlled, in general step up one treatment step. For patients who have very poor asthma control, consider increasing treatment by two steps, a course of oral corticosteroids, or both (Evidence D).
  • Address the risk domain.
    • The Expert Panel recommends the following actions if control of the risk of exacerbations is not achieved or maintained (Evidence D):
      • 0 to 4 years of age: If there is a history of one or more exacerbations, review adherence to medications and control of environmental exposures, review the patient's written asthma action plan to confirm that it includes oral prednisone for patients who have histories of severe exacerbations, and consider stepping up therapy to the next level (Evidence D).
      • 5 to 11 years of age: If the history of exacerbations suggests poorer control than does the assessment of impairment, the following actions are recommended: reassess the impairment domain, review adherence to medications and control of environmental exposures, review the patient's written asthma action plan to confirm that it includes oral prednisone for patients who have a history of severe exacerbations, and consider a step up in therapy, especially for children who have reduced lung function (Fuhlbrigge et al., 2001; 2006).
    • Address the risk domain with regard to side effects.

      The Expert Panel recommends consideration of alternative and/or adjunctive therapies within the step of care the patient is receiving if the patient experiences troublesome or debilitating side effects. In addition, confirm efforts to control environmental exposures (Evidence D).

  • Consider referral to an asthma specialist. The Expert Panel recommends referral to an asthma specialist for consultation or comanagement of the patient if (Evidence D):
    • There are difficulties achieving or maintaining control of asthma.
    • A child 0 to 4 years of age requires step 3 care or higher (step 4 care or higher for children 5 to 11 years of age) to achieve and maintain control or if additional education is indicated to improve the patients' management skills or adherence. Referral may be considered if a child 0 to 4 years of age requires step 2 care or a child 5 to 11 years of age requires step 3 care.
    • The patient has had an exacerbation requiring hospitalization.
    • Immunotherapy or other immunomodulators are considered, or additional tests are indicated, to determine the role of allergy.

Maintaining Control of Asthma

The Expert Panel recommends that regular follow up contact is essential (Evidence B). Contact at 1- to 6-month intervals is recommended, depending on the level of control; consider a 3-month interval if a step down in therapy is anticipated (Evidence D).

The Expert Panel recommends that once well-controlled asthma is achieved and maintained for at least 3 months, a reduction in pharmacologic therapy—a step down—can be considered helpful to identify the minimum therapy for maintaining well-controlled asthma (Evidence D). The opinion of the Expert Panel is that the dose of ICS may be reduced about 25 to 50 percent every 3 months to the lowest dose possible required to maintain control (Evidence D).

Key Points: Inhaled Corticosteroids in Children

  • ICSs are the preferred therapy for initiating long-term control therapy in children of all ages (Evidence A).
  • ICSs, especially at low doses and even for extended periods of time, are generally safe (Evidence A).
  • The potential for the adverse effect of low- to medium-dose ICS on linear growth is usually limited to a small reduction in growth velocity, approximately 1 cm in the first year of treatment, that is generally not progressive over time (Evidence A). Children receiving ICS should be monitored, by using a stadiometer, for changes in growth (Evidence D).
  • The potential risks of ICSs are well balanced by their benefits.
  • High doses of ICS administered for prolonged periods of time (for example, more than 1 year), particularly in combination with frequent courses of systemic corticosteroid therapy, may be associated with adverse growth effects and risk of posterior subcapsular cataracts or reduced bone density. Age-appropriate dietary intake of calcium and vitamin D should be reviewed with the child's caregivers (Evidence D). Slit-lamp eye exam and bone densitometry should be considered (Evidence D).
  • See also the NGC summary of the NAEPP guideline, Medications.

Key Points: Managing Asthma in Children 0 to 4 Years of Age

  • Diagnosing asthma in infants is often difficult. Underdiagnosis and undertreatment are key problems in this age group. However, not all wheeze and cough are caused by asthma, and caution is needed to avoid giving inappropriate prolonged asthma therapy (EPR—2 1997). Thus, a diagnostic trial of asthma medications may be helpful.
  • Treatment for young children, especially infants, who have asthma has not been studied adequately. Most recommendations for treatment are based on limited data and extrapolations from studies in older children and adults.
  • The initiation of long-term control therapy:
    • Is recommended for reducing impairment and risk of exacerbations in infants and young children who had four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND who have either (1) one of the following: a parental history of asthma, a physician's diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens OR (2) two of the following: evidence of sensitization to foods, ≥4 percent peripheral blood eosinophilia, or wheezing apart from colds (Evidence A).
    • Should be considered for reducing impairment in infants and young children who consistently require symptomatic treatment more than 2 days per week for a period of more than 4 weeks (Evidence D).
    • Should be considered for reducing risk in infants and young children who have two 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).
  • When initiating daily long-term control therapy, daily ICS is the preferred treatment (Evidence A). Alternative treatment options (listed here in alphabetical order) include cromolyn (Evidence B—extrapolated from studies in older children) or leukotriene receptor antagonist (LTRA) (montelukast). The initial choice of long-term control medication includes consideration of treatment effectiveness, the domain of particular relevance for the individual patient (impairment, risk, or both), the patient's history of previous response to therapies, the ability of the patient and family to use the medication correctly, and anticipated patient and family adherence to the treatment regimen (Evidence D).
  • Response to therapy should be carefully monitored. If there is a clear and positive response for at least 3 months, a careful step down in therapy should be attempted to identify the lowest dose required to maintain control. If clear benefit is not observed within 4 to 6 weeks and patient/family medication technique and adherence are satisfactory, the therapy should be discontinued and alternative therapies or diagnoses should be considered (Evidence D).
  • Administration of an ICS early in the course of the disease will not alter the underlying progression of the disease (Evidence A). ICSs should be used to control symptoms, prevent exacerbations, and improve the child's quality of life, but their use should not be initiated or prolonged for the purpose of changing the progression or underlying severity of the disease.

Note: The following recommendations for different steps of pharmacologic therapy to gain and maintain asthma control are intended to be general guidelines for making therapeutic decisions. They are not intended to be prescriptions for individual treatment. Specific therapy should be tailored to the needs and circumstances of individual patients. Pharmacologic therapy must be accompanied at every step by measures to control those environmental factors and comorbid conditions that can impede asthma control and by patient education. (See the NGC summaries of the NAEPP guidelines, Education for a Partnership in Asthma Care and Control of Environmental Factors and Comorbid Conditions That Affect Asthma).

Treatment: Pharmacologic Issues for Children 0–4 Years of Age

The Expert Panel recommends that treatment of young children is often in the form of a therapeutic trial; therefore, it is essential to monitor the child's response to therapy. If there is no clear response within 4 to 6 weeks, the therapy should be discontinued and alternative therapies or alternative diagnoses considered (Evidence D). If there is a clear and positive response for at least 3 months, a step down in therapy should be undertaken to the lowest possible doses of medication required to maintain asthma control (Evidence D).

Treatment: Pharmacologic Steps for Children 0 to 4 Years of Age

Intermittent Asthma

Step 1 Care, Children 0 to 4 Years of Age

The Expert Panel recommends the following treatment for intermittent asthma:

  • SABA taken as needed to treat symptoms is usually sufficient therapy for intermittent asthma (EPR—2 1997).
  • The Expert Panel recommends the following actions for managing exacerbations due to viral respiratory infections, which are especially common in children (EPR—2 1997). These exacerbations may be intermittent yet severe.
    • If the symptoms are mild, SABA (every 4 to 6 hours for 24 hours, longer with a physician consult) may be sufficient to control symptoms and improve lung function. If this therapy needs to be repeated more frequently than every 6 weeks, consider a step up in long-term care.
    • If the viral respiratory infection provokes a moderate-to-severe exacerbation, a short course of oral systemic corticosteroids should be considered (1 mg/kg/day prednisone or equivalent for 3 to 10 days).
    • For those patients who have a history of severe exacerbations with viral respiratory infections, consider initiating oral systemic corticosteroids at the first sign of the infection.
  • The Expert Panel recommends that a detailed written asthma action plan be developed for those patients who have intermittent asthma and a history of severe exacerbations (Evidence B). (See the NGC summary of the NAEPP guideline, Education for a Partnership in Asthma Care).

Persistent Asthma

The Expert Panel recommends the following therapy for persistent asthma:

  • Daily long-term control medication at step 2 or above is recommended for children who had four or more wheezing episodes in 1 year and risk factors for persistent asthma (Evidence A). Consider daily therapy for children who have a second exacerbation requiring oral systemic corticosteroids in 6 months or children who consistently require symptomatic treatment >2 days a week for > 4 weeks (Evidence D).
  • Quick-relief medication must be available. SABA should be taken as needed to relieve symptoms (EPR—2 1997). The intensity of treatment will depend on the severity of the exacerbation (See the NGC summary of the NAEPP guideline, Managing Exacerbations of Asthma).
  • To gain more rapid control of asthma, a course of oral systemic corticosteroids may be necessary for the patient who has an exacerbation at the time long-term control therapy is started or in patients who have moderate or severe asthma with frequent interference with sleep or normal activity (EPR—2 1997).
  • Close monitoring of the child's response to therapy is recommended (EPR—2 1997); treatment recommendations are based on limited data in this age group, and thus treatment is often in the form of a therapeutic trial. If no clear response occurs within 4 to 6 weeks and medication technique and adherence are satisfactory, the treatment should be discontinued and a change in therapy or alternative diagnoses should be considered. If there is a clear and positive response for at least 3 months, a step down in therapy should be undertaken to the lowest possible doses of medication required to maintain asthma control (Evidence D).
  • Giving daily therapy only during specific periods of previously documented risk for a child may be considered (Evidence D).

Step 2 Care, Children 0 to 4 Years of Age

  • Preferred treatment for step 2 care is daily ICS at a low dose (Evidence A based on studies of individual drug efficacy in this age group; comparator trials are not available).
  • Alternative, but not preferred, treatments include (listed in alphabetical order) cromolyn (Evidence B—extrapolated from studies in older children) and montelukast (Evidence A). If an alternative treatment is selected and adequate asthma control is not achieved and maintained in 4 to 6 weeks, then discontinue that treatment and use the preferred medication before stepping up therapy.
  • Theophylline is not recommended as alternative treatment (EPR—2 1997) because of its erratic metabolism during viral infections and febrile illness in children less than 5 years of age and the need to closely monitor and control serum concentrations.

Step 3 Care, Children 0 to 4 Years of Age

  • Medium-dose ICS is the preferred step 3 treatment (Evidence D). The Expert Panel recommends increasing the dose of ICS, for children 0 to 4 years of age whose asthma is not well controlled on low doses of ICS, to ensure that an adequate dose is delivered (due to the inherent difficulty and variability of delivering aerosols) before adding adjunctive therapy (Evidence D).

Step 4 Care, Children 0 to 4 Years of Age

  • Medium-dose ICS AND either (listed in alphabetical) long-acting beta2–agonists (LABA) or montelukast is the preferred treatment for step 4 (Evidence D). Theophylline is not recommended as add-on therapy (EPR—>2 1997).

Step 5 Care, Children 0 to 4 Years of Age

  • High-dose ICS AND either LABA or montelukast is the preferred treatment (Evidence D).

Step 6 Care, Children 0 to 4 Years of Age

  • High-dose ICS AND either LABA or montelukast AND oral systemic corticosteroids may be given for step 6 (Evidence D).

Key Points: Managing Asthma in Children 5 to 11 Years of Age

  • Classification of severity, considering the new dimensions of both the impairment and risk domains, should guide decisions for initiating therapy in children not currently taking long-term control medications (EPR—2 1997).
  • Assessment of asthma control, considering both the impairment and risk domains, should guide decisions for adjusting therapy—either stepping up (Evidence A) or stepping down (Evidence D).
  • When initiating daily long-term control therapy for persistent asthma, daily ICS is the preferred treatment (Evidence A); alternative treatment options include cromolyn, LTRA, and theophylline (Evidence B). The choice of medication includes consideration of treatment effectiveness, the domain of particular relevance to the individual patient (impairment, risk, or both), the individual patient's history of previous response to therapies, the ability of the patient and family to use the medication correctly, and anticipated patient and family adherence with the treatment regime and cost (Evidence D).
  • Administration of ICS early in the course of the disease will not alter the underlying progression of the disease. ICSs should be used to control symptoms, prevent exacerbations, and improve the child's quality of life, but their use should not be initiated or prolonged for the purpose of changing the progression or underlying severity of the disease (Evidence A).
  • Children should be directly involved as much as possible in establishing goals for therapy and developing their written asthma action plans.
  • Active participation in physical activities, exercise, and sports should be promoted (EPR—2 1997). Treatment immediately before vigorous activity or exercise usually prevents EIB. If symptoms occur during usual play activities, a step up in treatment is warranted (EPR—2 1997).
  • A written asthma action plan should be prepared for the student's school, extended care, or camp, including the clinician's recommendation regarding self-administration of medication. Either encourage parents to take a copy to the child's school or obtain parental permission and send a copy to the school nurse or designee (Evidence C).

Note: The following recommendations for pharmacologic therapy to gain and maintain asthma control (See figures 4–1b, 4–3b, 4–4a, b, and c in the original guideline document) are intended to be general guidelines for making therapeutic decisions. They are not intended to be prescriptions for individual treatment or to replace clinical judgment. Specific therapy should be tailored to the need and circumstances of individual patients. Pharmacologic therapy must be accompanied at every step by patient education and measures to control those environmental factors and comorbid conditions that can impede asthma control.

Treatment: Special Issues for Children 5 to 11 Years of Age

Pharmacologic Issues

The Expert Panel recommends that, when initiating daily long-term control therapy for mild or moderate persistent asthma, the choice of medication includes consideration of treatment effectiveness, the domain of particular relevance to the patient's asthma (impairment, risk, or both), the individual patient's history of previous response to therapies, the ability of the patient and family to use the medication correctly, anticipated patient and family adherence to the treatment regimen, and cost (Evidence D).

The Expert Panel recommends that children >10 years of age (and younger children as appropriate) be directly involved in developing their written asthma action plans (EPR—2 1997).

School Issues

The Expert Panel recommends that the clinician prepare a written asthma action plan for the student's school or childcare setting. Either encourage parents to take a copy to the child's school or obtain parental permission and send a copy to the school nurse or designee (Evidence C).

Sports and Exercise Issues

The Expert Panel recommends that physical activity at play or in organized sports is an essential part of a child's life, and full participation in physical activities should be encouraged (EPR—2 1997).

Treatment: Pharmacologic Steps for Children 5 to 11 Years of Age

Intermittent Asthma

Step 1 Care, Children 5 to 11 Years of Age

The Expert Panel recommends the following therapy for intermittent asthma (step 1 care):

  • SABA, taken as needed to treat symptoms, is usually sufficient therapy for intermittent asthma.
  • Manage moderate or severe exacerbations due to viral respiratory infections, especially common in children, with a short course of oral systemic corticosteroids. Consider initiating systemic corticosteroids at the first sign of infection in children who have a history of severe exacerbations with viral respiratory infections (Evidence D).
  • Provide a detailed written asthma action plan for those patients who have intermittent asthma and a history of severe exacerbations (Evidence B).

Persistent Asthma

The Expert Panel recommends the following therapy for persistent asthma:

  • Use daily long-term control medication. The most effective long-term control medications are those with anti-inflammatory effects, that is, those that diminish chronic airway inflammation and airway hyperresponsiveness (Evidence A).
  • Quick-relief medication must be available. SABA, taken as needed to relieve symptoms, is recommended (Evidence A).
  • To gain more rapid control of asthma, consider a course of oral systemic corticosteroids for the patient who has an exacerbation at the time long-term control therapy is started or in patients who have moderate or severe asthma with frequent interference with sleep or normal activity (EPR—2 1997).
  • Giving daily therapy only during specific periods of previously documented risk for a child may be considered (Evidence D).
  • Consider treating patients who had two or more exacerbations requiring oral systemic corticosteroids in the past year the same as patients who have persistent asthma, even in the absence of an impairment level consistent with persistent asthma (Evidence D).

Step 2 Care, Children 5 to 11 Years of Age

  • Daily low-dose ICS is the preferred step 2 treatment (Evidence A).
  • Alternative treatments at this step include (listed in alphabetical order) cromolyn, LTRA, nedocromil, and theophylline (Evidence B).

Step 3 Care, Children 5 to 11 Years of Age

  • Low-dose ICS plus the addition of some form of adjunctive therapy or medium-dose ICS are equivalent options in step 3 care, based on extrapolation from studies in adults (Evidence B—extrapolation). Because of the lack of comparative data in this age group, however, the adjunctive therapies are listed in alphabetical order: LABA, LTRA, or, with appropriate monitoring, theophylline.

Step 4 Care, Children 5 to 11 Years of Age

  • Medium-dose ICS AND LABA is the preferred step 4 treatment (Evidence B—extrapolated from studies in youths >12 years and adults).
  • Alternative, but not preferred, treatment is medium-dose ICS AND either LTRA or theophylline (Evidence B—extrapolated from studies in youths >12 years of age and adults).
  • In the opinion of the Expert Panel, if the add-on therapy initially administered does not lead to improvement in asthma control, discontinue it and use a trial of a different add-on therapy before stepping up.

Step 5 Care, Children 5 to 11 Years of Age

  • High-dose ICS AND LABA is the preferred step 5 treatment based on extrapolation from studies in older children and adults (Evidence B—extrapolated).
  • Alternative, but not preferred, add-on treatments include LTRA or theophylline (Evidence B—extrapolated).

Step 6 Care, Children 5 to 11 Years of Age

  • High-dose ICS AND LABA AND oral systemic corticosteroids long term is the preferred treatment (Evidence D).
  • Alternative, but not preferred, add-on treatments are either an LTRA or theophylline AND oral systemic corticosteroids (Evidence D).

Definitions:

Levels of Evidence

The system* used to describe the level of evidence is as follows:

Evidence Category A: Randomized controlled trials (RCTs), rich body of data.
Evidence is from end points of well-designed RCTs that provide a consistent pattern of findings in the population for which the recommendation is made. Category A requires substantial numbers of studies involving substantial numbers of participants.

Evidence Category B: RCTs, limited body of data.
Evidence is from end points of intervention studies that include only a limited number of patients, post hoc or subgroup analysis of RCTs, or meta-analysis of RCTs. In general, category B pertains when few randomized trials exist; they are small in size, they were undertaken in a population that differs from the target population of the recommendation, or the results are somewhat inconsistent.

Evidence Category C: Nonrandomized trials and observational studies.
Evidence is from outcomes of uncontrolled or nonrandomized trials or from observational studies.

Evidence Category D: Panel consensus judgment.
This category is used only in cases where the provision of some guidance was deemed valuable, but the clinical literature addressing the subject was insufficient to justify placement in one of the other categories. The Panel consensus is based on clinical experience or knowledge that does not meet the criteria for categories A through C.

*Source: Jadad AR, Moher M, Browman GP, Booker L, Sigouin C, Fuentes M, Stevens R. Systematic reviews and meta-analyses on treatment of asthma: critical evaluation. BMJ 2000;320(7234):537-40.

Strength of Recommendations

In addition to specifying the level of evidence supporting a recommendation, the Expert Panel agreed to indicate the strength of the recommendation. When a certain clinical practice "is recommended," this indicates a strong recommendation by the panel. When a certain clinical practice "should, or may, be considered," this indicates that the recommendation is less strong.

This distinction is an effort to address nuances of using evidence ranking systems. For example, a recommendation for which clinical RCT data are not available (e.g., conducting a medical history for symptoms suggestive of asthma) may still be strongly supported by the Panel. Furthermore, the range of evidence that qualifies a definition of "B" or "C" is wide, and the Expert Panel considered this range and the potential implications of a recommendation as they decided how strongly the recommendation should be presented.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

REFERENCES SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Managing asthma long term in children 0-4 years of age and 5-11 years of age. In: National Asthma Education and Prevention Program (NAEPP). Expert panel report 3: guidelines for the diagnosis and management of asthma. Bethesda (MD): National Heart, Lung, and Blood Institute; 2007 Aug. p. 281-325. [84 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

1997 (revised 2007 Aug)

GUIDELINE DEVELOPER(S)

National Asthma Education and Prevention Program - Federal Government Agency [U.S.]
National Heart, Lung, and Blood Institute (U.S.) - Federal Government Agency [U.S.]

GUIDELINE DEVELOPER COMMENT

The National Asthma Education and Prevention Program Science Base Committee is a multidisciplinary group of clinicians and scientists with expertise in asthma management. The group includes health professionals in the areas of general medicine, family practice, pediatrics, emergency and critical care, allergy, pulmonary medicine, pharmacy, and health education.

SOURCE(S) OF FUNDING

The development of this report was entirely funded by the National Heart, Lung, and Blood Institute, National Institutes of Health.

GUIDELINE COMMITTEE

National Asthma Education and Prevention Program (NAEPP) Coordinating Committee
Third Expert Panel on the Diagnosis and Management of Asthma

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Third Expert Panel on the Diagnosis and Management of Asthma Members: William W. Busse, MD (Chair), University of Wisconsin Medical School, Madison, WI; Homer A. Boushey, MD, University of California at San Francisco, San Francisco, CA; Carlos A. Camargo, MD, DrPH, Massachusetts General Hospital, Boston, MA; David Evans, PhD, AE-C., Columbia University, New York, NY; Michael B. Foggs, MD, Advocate Health Care, Chicago, IL; Susan Janson, DNSc, RN, University of California, San Francisco, California; H. William Kelly, PharmD, University of New Mexico Health Sciences Center, Albuquerque, NM; Robert F. Lemanske, MD, University of Wisconsin Hospital and Clinics, Madison, WI; Fernando D. Martinez, MD, University of Arizona Medical Center, Tucson, AZ; Robert J. Meyer, MD, U.S. Food and Drug Administration, Rockville, MD; Harold S. Nelson, MD, National Jewish Medical and Research Center, Denver, CO; Thomas A.E. Platts-Mills, MD, PhD, University of Virginia School of Medicine, Charlottesville, VA; Michael Schatz, MD, MS, Kaiser-Permanente Medical Center, San Diego, CA; Gail Shapiro, MD (deceased), Northwest Asthma and Allergy Center, Seattle, WA; Stuart Stoloff, MD, University of Nevada School of Medicine, Carson City, NV; Stanley Szefler, MD, National Jewish Medical and Research Center, Denver, CO; Scott T. Weiss, MD, MS, Brigham and Women's Hospital, Boston, MA; Barbara P. Yawn, MD, MSc, Olmstead Medical Center, Rochester, MN

See the original guideline document for members of the National Asthma Education and Prevention Program (NAEPP) Coordinating Committee, a list of consultant reviewers, and members of the National Heart, Lung, and Blood Institute and American Institutes for Research staffs.

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Development of the resource document and the guidelines report was funded by the National Heart, Lung, and Blood Institute (NHLBI), and National Institutes of Health (NIH). Expert Panel members completed financial disclosure forms, and the Expert Panel members disclosed relevant financial interests to each other prior to their discussions. Expert Panel members participated as volunteers and were compensated only for travel expenses related to the Expert Panel meetings. Financial disclosure information covering the 3-year period during which the guidelines were developed is provided for each Panel member below.

Dr. Busse has served on the Speakers' Bureaus of GlaxoSmithKline, Merck, Novartis, and Pfizer; and on the Advisory Boards of Altana, Centocor, Dynavax, Genentech/Novartis, GlaxoSmithKline, Isis, Merck, Pfizer, Schering, and Wyeth. He has received funding/grant support for research projects from Astellas, AstraZeneca, Centocor, Dynavax, GlaxoSmithKline, Novartis, and Wyeth. Dr. Busse also has research support from the NIH.

Dr. Boushey has served as a consultant for Altana, Protein Design Lab, and Sumitomo. He has received honoraria from (Boehringer-Ingelheim, Genentech, Merck, Novartis, and Sanofi-Aventis, and funding/grant support for research projects from the NIH.

Dr. Camargo has served on the Speakers' Bureaus of AstraZeneca, GlaxoSmithKline, Merck, and Schering-Plough; and as a consultant for AstraZeneca, Critical Therapeutics, Dey Laboratories, GlaxoSmithKline, MedImmune, Merck, Norvartis, Praxair, Respironics, Schering-Plough, Sepracor, and TEVA. He has received funding/grant support for research projects from a variety of Government agencies and not-for-profit foundations, as well as AstraZeneca, Dey Laboratories, GlaxoSmithKline, MedImmune, Merck, Novartis, and Respironics.

Dr. Evans has received funding/grant support for research projects from the NHLBI.

Dr. Foggs has served on the Speakers' Bureaus of GlaxoSmithKline, Merck, Pfizer, Sepracor, and UCB Pharma; on the Advisory Boards of Alcon, Altana, AstraZeneca, Critical Therapeutics, Genentech, GlaxoSmithKline, and IVAX; and as consultant for Merck and Sepracor. He has received funding/grant support for research projects from GlaxoSmithKline.

Dr. Janson has served on the Advisory Board of Altana, and as a consultant for Merck. She has received funding/grant support for research projects from the NHLBI.

Dr. Kelly has served on the Speakers' Bureaus of AstraZeneca and GlaxoSmithKline; and on the Advisory Boards of AstraZeneca, MAP Pharmaceuticals, Merck, Novartis, and Sepracor.

Dr. Lemanske has served on the Speakers' Bureaus of GlaxoSmithKline and Merck, and as a consultant for AstraZeneca, Aventis, GlaxoSmithKline, Merck, and Novartis. He has received honoraria from Altana, and funding/grant support for research projects from the NHLBI and NIAID.

Dr. Martinez has served on the Advisory Board of Merck and as a consultant for Genentech, GlaxoSmithKline, and Pfizer. He has received honoraria from Merck.

Dr. Meyer has no relevant financial interests.

Dr. Nelson has served on the Speakers' Bureaus of AstraZeneca, GlaxoSmithKline, Pfizer, and Schering-Plough; and as a consultant for Abbott Laboratories, Air Pharma, Altana Pharma US, Astellas, AstraZeneca, Curalogic, Dey Laboratories, Dynavax Technologies, Genentech/Novartis, GlaxoSmithKline, Inflazyme Pharmaceuticals, MediciNova, Protein Design Laboratories, Sanofi-Aventis, Schering-Plough, and Wyeth Pharmaceuticals. He has received funding/grant support for research projects from Altana, Astellas, AstraZeneca, Behringer, Critical Therapeutics, Dey Laboratories, Epigenesis, Genentech, GlaxoSmithKline, Hoffman LaRoche, IVAX, Medicinova, Novartis, Sanofi-Aventis, Schering-Plough, Sepracor, TEVA, and Wyeth.

Dr. Platts-Mills has served on the Advisory Committee of Indoor Biotechnologies. He has received funding/grant support for a research project from Pharmacia Diagnostics.

Dr. Schatz has served on the Speakers' Bureaus of AstraZeneca, Genentech, GlaxoSmithKline, and Merck; and as a consultant for GlaxoSmithKline on an unbranded asthma initiative. He has received honoraria from AstraZeneca, Genentech, GlaxoSmithKline and Merck. He has received funding/grant support for research projects from GlaxoSmithKline and Merck and Sanofi-Adventis.

Dr. Shapiro (deceased) served on the Speakers' Bureaus of AstraZeneca, Genentech, GlaxoSmithKline, IVAX Laboratories, Key Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Schering Corporation, UCB Pharma, and 3M; and as a consultant for Altana, AstraZeneca, Dey Laboratories, Genentech/Novartis, GlaxoSmithKline, ICOS, IVAX Laboratories, Merck, Sanofi-Aventis, and Sepracor. She received funding/grant support for research projects from Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers-Squibb, Dey Laboratories, Fujisawa Pharmaceuticals, Genentech, GlaxoSmithKline, Immunex, Key, Lederle, Lilly Research, MedPointe Pharmaceuticals, Medtronic Emergency Response Systems, Merck, Novartis, Pfizer, Pharmaxis, Purdue Frederick, Sanofi-Aventis, Schering, Sepracor, 3M Pharmaceuticals, UCB Pharma, and Upjohn Laboratories.

Dr. Stoloff has served on the Speakers' Bureaus of Alcon, Altana, AstraZeneca, Genentech, GlaxoSmithKline, Novartis, Pfizer, Sanofi-Aventis, and Schering; and as a consultant for Alcon, Altana, AstraZeneca, Dey, Genentech, GlaxoSmithKline, Merck, Novartis, Pfizer, Sanofi-Aventis, and Schering.

Dr. Szefler has served on the Advisory Boards of Altana, AstraZeneca, Genentech, GlaxoSmithKline, Merck, Novartis, and Sanofi-Aventis; and as a consultant for Altana, AstraZeneca, Genentech, GlaxoSmithKline, Merck, Novartis, and Sanofi-Aventis. He has received funding/grant support for a research project from Ross.

Dr. Weiss has served on the Advisory Board of Genentech, and as a consultant for Genentech and GlaxoSmithKline. He has received funding/grant support for research projects from GlaxoSmithKline.

Dr. Yawn has served on the Advisory Boards of Altana, AstraZeneca, Merck, Sanofi-Aventis, and Schering-Plough. She has received honoraria from Pfizer and Schering-Plough, and funding/grant support for research projects from the Agency for Healthcare Research and Quality, the CDC, the NHLBI, Merck, and Schering-Plough.

Financial disclosure information covering a 12 month period prior to the review of the guidelines is provided in the original guideline document for each consultant reviewer.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: National Asthma Education and Prevention Program Expert Panel Report: guidelines for the diagnosis and management of asthma update on selected topics-2002. J Allergy Clin Immunol 2002 Nov;110(5 pt 2):S141-219.

GUIDELINE AVAILABILITY

Electronic copies: Available from the National Heart, Lung, and Blood Institute Web site.

Print copies: Available from NHLBI Information Center, P.O. Box 30105, Bethesda, MD 20824-0105; e-mail: nhlbiic@dgsys.com.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Print copies: Available from NHLBI Information Center, P.O. Box 30105, Bethesda, MD 20824-0105; e-mail: nhlbiic@dgsys.com.

Additional tools, including sample monitoring records, can be found in the original guideline document.

PATIENT RESOURCES

The following is available:

  • Lung diseases information. Information for patients and the public.

Electronic copies: Available from the National Heart, Lung and Blood Institute Web site.

Print copies: Available from NHLBI Information Center, P.O. Box 30105, Bethesda, MD 20824-0105; e-mail: nhlbiic@dgsys.com.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC STATUS

This summary was completed by ECRI on January 5, 1999. The information was verified by the guideline developer on April 30, 1999. This summary was updated by ECRI on January 31, 2003. This information was not verified by the guideline developer. This summary was updated by ECRI on December 5, 2005 following the U.S. Food and Drug Administration (FDA) advisory on long-acting beta2-adrenergic agonists (LABA). This NGC summary was updated by ECRI Institute on January 14, 2008.

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