ANSWER
Determine the severity of asthma (EPR—2 1997). Asthma severity is determined by impairment and risk measurements; see figure 4-6 and the discussion in “Component 1: Asthma Assessment and Monitoring.”
▪ Choose a treatment based on the severity of the patient’s asthma (EPR—2 1997). Figure 4-6 depicts the recommended care step at various levels of seriousness, and Figure 4-5 illustrates treatment options at each stage of care. Medication dosages are shown in figures 4-8a, b, and c. However, the clinician must also assess the individual patient’s needs and circumstances to determine when to begin therapy. For example, patients with moderate or severe asthma who frequently interfere with sleep or regular activity may benefit from oral corticosteroids to gain more control of their asthma. The response of each patient to treatment must also be evaluated.
If asthma is not well controlled at a follow-up visit 2-6 weeks after starting treatment, depending on severity (see below), treatment should be advanced to the next step. If uncontrolled asthma persists, the diagnosis should be reevaluated, and treatment should be moved to another step if confirmed (Evidence D).

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USUAL DOSAGES FOR LONG-TERM CONTROL MEDICATIONS FOR ADULTS AND YOUTHS 12 YEARS OF AGE

USUAL DOSAGES FOR QUICK-RELIEF MEDICATIONS FOR ADULTS AND YOUTHS 12 YEARS OF AGE

Adaptive Therapy
The Expert Panel recommends that, once therapy is chosen, or if the clinician sees a patient for the first time who is already on a long-term control medication, treatment decisions be made based on the patient’s level of asthma control (See figure 4-7.) (Example A).

Evaluate asthma control. As with asthma severity, asthma control can be thought of in terms of impairment and risk domains (Evidence C). To select appropriate therapy, both parts should be addressed; the level of control is generally judged on the most severe indicator of impairment or risk (Evidence D).
Domain of Impairment
This domain is multifactorial because the various manifestations of asthma do not always correlate, and each factor should be evaluated if possible (Evidence C).

Symptoms
Each of the three types of symptom assessments appears to provide specific information about asthma control: symptom frequency, nighttime awakening, and activity limitation (Fuhlbrigge et al., 2002; Nathan et al., 2004; Vollmer et al., 1999). Shortness of breath frequency appears to be mainly related to asthma control (Nathan et al., 2004) and quality of life (Moy et al., 2001).

Use of SABA
SABA use frequency is a good indicator of both short-term (past month) and long-term (past year) asthma control (Nathan et al., 2004; Vollmer et al., 1999). (Schatz et al. 2006). If quick relief and prophylactic use are not separated, frequent SABA before exercise may confound these measures.

Respiratory function
Control in treated patients is reflected by office spirometry (prebronchodilator) or home peak flow measurements (Bateman et al., 2004; Juniper et al., 1999, 2001). Pulmonary function tests may be unreliable predictors of asthma symptoms (Shingo et al., 2001; Stahl, 2000).

Questionnaires that have been validated
Several validated tools for measuring asthma control have been developed (Juniper et al., 1999; Nathan et al., 2004; Vollmer et al., 1999) and can be used to classify asthma control. (See Figure 3-8 for “Component 1: Asthma Assessment and Monitoring Measures.”)

Domain of Danger
The risk domain includes the occurrence of treatment-related adverse effects and the frequency and severity of exacerbations. Patients with any level of impairment control may experience severe exacerbations. Previous exacerbations, particularly those that resulted in ED visits or hospitalizations within the previous year, significantly increase the risk of future exacerbations (Adams et al., 2000; Cowie et al., 2001; Eisner et al., 2001; Lieu et al., 1998; Schatz et al., 2004; Yurk et al., 2004). This emphasizes the importance of obtaining a history of previous exacerbations requiring hospitalization (including ICU admission or intubation), ED visits, and other unscheduled physician visits. Furthermore, decreasing FEV1 categories >80 percent, 60-79 percent, and 60 percent predicted is associated with increasing exacerbation rates (Fuhlbrigge et al. 2001, 2006; Kitch et al., 2004).

Controlling impairment is generally thought to reduce the risk of exacerbations (Schatz et al., 2005; Vollmer et al., 1999), but there may be a disconnect between the two. Control based on bronchial hyperreactivity (Sont et al., 1999), sputum eosinophilia (Green et al., 2002), or possibly fractional exhaled nitric oxide (FeNO) (Smith et al., 2005) is more effective than control based on clinical markers alone in reducing exacerbations. However, more research is needed, and only FeNO monitoring may become practical enough to be used clinically.

Adapt therapy based on asthma control level (Evidence A). The following factors will guide therapy selection based on the level of asthma control. In general, classify current asthma control by the most severe indicator of impairment or risk (figure 4-7). (Evidence D).
— If the patient’s asthma is not under control: Determine the patient’s current treatment step (figure 4-5) based on his or her medications. Step up one step in general for patients with uncontrolled asthma. Consider increasing by two steps, a course of oral corticosteroids or both for patients with poorly controlled asthma. Consider poor inhaler technique, adverse environmental exposures, poor adherence, or comorbidities as intervention targets before increasing pharmacologic therapy. If office spirometry indicates worse control than the assessment of impairment based on other measures, (1) consider fixed airway obstruction as the explanation (Aburuz et al., 2005) (See “Component 1: Measures of Asthma Assessment and Monitoring.”) and use changes from percent personal best rather than percent predicted to guide therapy; (2) reassess the other measures of impairment; and (3) if fixed airway obstruction does not appear to be the explanation, consider constriction of the airways. If the history of exacerbations indicates poorer control than the assessment of impairment, (1) reassess impairment; (2) review control of factors capable of worsening asthma (e.g., lack of adherence, adverse environmental exposure, or comorbidities); (3) review the written action plan, and ensure it includes oral prednisone for patients with histories of severe exacerbations; and (4) consider a step up in therapy, especially if the patient has reduced FEV1. Consider changing your therapy if you are experiencing bothersome or debilitating side effects. Furthermore, confirm that all efforts are being made to control factors that can aggravate asthma (See “Component 3: Control of Environmental Factors and Comorbid Conditions That Affect Asthma.”).
♦ Reevaluate 2-6 weeks after treatment has been adjusted, depending on the level of control. — If the patient’s asthma is under control, proceed to the section on “Maintaining Control of Asthma.”
ASTHMA CONTROL MAINTENANCE
The Expert Panel believes regular follow-up contact is critical (Evidence B). Contact should be made at 1- to 6-month intervals, depending on the level of control; consider 3-month intervals if a step down in therapy is expected (Evidence D). Clinicians must determine whether asthma control has been maintained and whether therapy should be increased or decreased. Clinicians must also monitor and review the patient’s written asthma action plan, medications, and self-management behaviors (e.g., inhaler and peak flow monitoring techniques, actions to control aggravating factors) (See “Component 2: Education for a Partnership in Asthma Care,” figures 3-11 and 3-15.).

The Expert Panel recommends that once asthma is well controlled and maintained for at least three months, a reduction in pharmacologic therapy (a step down) be considered. This will aid in determining the bare minimum of therapy required to maintain reasonable asthma control (Evidence D). Because asthma can deteriorate at a highly variable rate and intensity, reducing therapy should be done gradually and carefully. If and when the patient’s asthma worsens, he or she should be instructed to contact the clinician. Guidelines for the rate of reduction and evaluation intervals have yet to be validated, and clinical judgment of the individual patient’s response to therapy is critical. The Expert Panel believes that the dose of ICS should be reduced by 25-50 percent every three months to the lowest dose required to maintain control (Hawkins et al., 2003; Lemanske et al., 2001). Patients may relapse when the ICS is wholly stopped (Lemanske et al., 2001; Waalkens et al., 1993).

If asthma control is not achieved and maintained at any stage of care, the Expert Panel suggests that the following actions be taken:

Patient adherence and medication administration technique should be evaluated (Evidence B). The section “Component 2: Education for a Partnership in Asthma Care” discusses assessing adherence. Key questions to ask patients include: — What medications are you currently taking? How frequently?
— Please demonstrate how you take the medication.
— How often do you forget to take your medication?
— What issues have you encountered while taking the medication (cost, time, perceived need)?
— What are your concerns about your asthma medications?
To reestablish asthma control, a temporary increase in anti-inflammatory therapy may be indicated (Evidence D). Asthma deterioration may be characterized by a gradual decrease in PEF (approximately 20%), failure of SABA bronchodilators to produce a sustained response, decreased tolerance to activities or exercise, and the development of increasing symptoms or nocturnal awakenings from asthma. A short course of oral prednisone (See figure 4-8a.) is often effective in regaining asthma control. No further treatment is required if asthma symptoms do not recur and pulmonary functions remain normal. If the prednisone burst does not control symptoms, is only effective for a short time (e.g., less than 1-2 weeks), or is repeated frequently, the patient should be managed according to the next higher level of care.
Other factors limiting control may need to be identified and addressed (Evidence C). The presence of a coexisting condition (e.g., rhinitis/sinusitis, gastroesophageal reflux, obesity), new or increased exposure to allergens or irritants, patient or family barriers to adequate self-management behaviors, or psychosocial problems are examples of these factors. Alternative diagnoses, such as VCD, should be considered in some cases.
A step up to the next higher level of care may be required (Evidence A).
Consultation with an asthma specialist may be necessary (See “Component 1: Asthma Assessment and Monitoring Measures”) (Evidence D). If there are difficulties achieving or maintaining asthma control, immunotherapy or Omalizumab is being considered, the patient requires step 4 care or higher, or the patient has had an exacerbation requiring hospitalization; the Expert Panel recommends referral to an asthma specialist for Consultation or co-management. (See “Component 1: Asthma Assessment and Monitoring Measures”). A referral may be considered if a patient requires step 3 care (Evidence D).
Go to: Pharmacologic Steps in Treatment
According to the Expert Panel, specific therapy should be tailored to the needs and circumstances of individual patients. At every step, pharmacologic therapy must be accompanied by patient education and measures to control environmental factors or comorbid conditions that can aggravate asthma (EPR—2 1997). See “Component 3: Control of Environmental Factors and Comorbid Conditions That Affect Asthma,” which discusses the role of allergen immunotherapy, and “Component 2: Education for Asthma Care Partnership.” Figure 4-5 depicts treatment options for the stepwise approach to asthma management in children aged 12 and adults. The recommendations for pharmacologic therapy steps are intended to be general guidelines to aid, rather than replace, clinical decision-making. The recommendations are not intended to be individual treatment plans.

ASTHMA ONCE IN A WHILE
For intermittent asthma, the Expert Panel recommends the following treatment:

SABA taken as needed to treat symptoms is usually enough therapy for intermittent asthma (EPR—2 1997). If SABA is effective in relieving infrequent symptoms and normalizing pulmonary function, it can be used on an as-needed basis. Suppose significant symptoms recur or SABA is required for quick-relief treatment more than twice a week (except for exacerbations caused by viral infections and EIB). In that case, the patient should be treated for persistent asthma (See below.).
Patients with intermittent asthma and EIB benefit from taking SABA, cromolyn, or nedocromil just before exercise (EPR—2 1997). (See “Exercise-Induced Bronchospasm” in “Managing Special Situations in Asthma.”). Cromolyn or nedocromil may be helpful if taken prior to unavoidable exposure to an aeroallergen known to aggravate the patient’s asthma (Cockcroft & Murdock, 1987).
The following actions are recommended for managing viral respiratory infection exacerbations (EPR—2 1997). SABA (every 4-6 hours for 24 hours, longer with a physician consult) may be sufficient to control symptoms and improve lung function if the symptoms are mild. If this therapy is required more frequently than every six weeks, a step up in long-term care is advised. A short course of systemic corticosteroids should be considered if the viral respiratory infection causes a moderate-to-severe exacerbation. Systemic corticosteroids should be considered the first sign of infection in patients with a history of severe exacerbations from viral respiratory infections. Patients with intermittent asthma, particularly those with a history of severe exacerbations, should have a detailed written asthma action plan (Evidence B) (See “Component 2: Education for a Partnership in Asthma Care.”). Intermittent asthma is often mild, with infrequent exacerbations separated by periods of no symptoms and normal pulmonary function. Some patients with intermittent asthma have sudden, severe, and potentially fatal exacerbations. It is critical to treat these exacerbations appropriately. The written asthma action plan for the patient should include indicators of worsening asthma (specific symptoms and PEF measurements), as well as specific recommendations for using SABA, starting a course of oral systemic corticosteroids early, and seeking medical care. Furthermore, periodic patient monitoring (See “Component 1: Measures of Asthma Assessment and Monitoring.”) is necessary to determine whether the patient’s asthma is intermittent or whether a step up in long-term therapy is necessary.
PERMANENT ASTHMA
The Expert Panel suggests the following treatment for persistent asthma:

Patients with persistent asthma should take long-term control medication daily. Long-term control medication should have anti-inflammatory properties. ICSs are the most influential single agents (Evidence A) (see component 4—Medications).
All patients with persistent asthma should have access to quick-relief medication. SABA should be taken as needed to relieve symptoms (EPR—2 1997). The treatment intensity will depend on the severity of the exacerbation (See section 5, “Managing Exacerbations of Asthma”). (See section 5, “Managing Exacerbations of Asthma.”). Increasing the use of SABA or use more than two days a week for symptom control (not for preventing EIB) indicates the need to step up therapy.
▪ Consider treating patients who may have seasonal asthma (asthma symptoms only about certain seasonal molds or pollens with few symptoms the rest of the year) as having persistent asthma during the season and intermittent asthma the rest of the year. Confirm characteristics of intermittent asthma out of season (Evidence D) (Evidence D). Some patients experience asthma symptoms only in relation to certain pollens and molds. Asthma exacerbations in children are common in the fall and seem to correlate with increased exposure to viral respiratory infections in the school environment (Hammerman et al., 2002; Johnston et al., 2005). (Hammerman et al. 2002; Johnston et al. 2005).
▪ Consider treating patients who had two or more exacerbations requiring oral corticosteroids in the past year, the same as patients with persistent asthma, even in the absence of an impairment level consistent with persistent asthma (Evidence D) (Evidence D).
Step 2 Care, Long-Term Control Medication
▪ Preferred treatment for step 2 care is daily ICS at a low dose (Evidence A) (Evidence A).
▪ Alternative, but not preferred, treatments include (listed alphabetically) cromolyn, LTRA, nedocromil (Evidence A), and sustained release theophylline (Evidence B) (Evidence B). There is insufficient evidence to recommend LABA in combination with ICS for step 2 therapy.
— Cromolyn and nedocromil have some, but limited, effectiveness and a strong safety profile.
— LTRAs (montelukast and zafirlukast) provide long-term control, prevent symptoms, and are alternative, but not preferred, therapies for patients who have mild persistent asthma because studies comparing the overall efficacy of ICS and LTRA favor ICS on most asthma outcome measures (Evidence A) (Evidence A). (See section 3, “Component 4: Medications.”) Zileuton, a leukotriene inhibitor, is not recommended in step 2 care because no studies of zileuton specifically in patients with mild persistent asthma have been reported, and zileuton requires liver function test monitoring (Evidence D) (Evidence D).
— Sustained-release theophylline is an alternative, but not preferred, long-term control medication. It is not preferred because the modest clinical effectiveness (theophylline is primarily a bronchodilator and its anti-inflammatory activity demonstrated thus far is modest) must be balanced against concerns about potential toxicity (See “Component 4: Medications”). (See “Component 4: Medications.”). Theophylline remains a therapeutic option for certain patients due to the expense or needs for tablet-form medication. Sustained-release theophylline is given to achieve a serum concentration of between 5 and 15 mcg/mL. Periodic theophylline monitoring is necessary to maintain a therapeutic—but not toxic—level.
— Insufficient evidence is available to recommend LABA in combination with ICS in step 2 care (O’Byrne et al., 2001). In steroid naïve patients who have mild persistent asthma, the initiation of an ICS in combination with a LABA does not significantly reduce the rate of exacerbations or the use of SABA for quick relief over that achieved with ICS alone. However, the combination therapy can improve lung function and symptom days compared to ICS alone (Ni et al., 2005). (Ni et al. 2005). Thus, there is insufficient efficacy evidence to recommend this combination therapy in step 2 care. In addition, the possibility of rare but potentially life-threatening outcomes with LABAs (See “Component 4: Medications.”) supports this recommendation.
— A recent study has suggested that some patients who have mild persistent asthma may be successfully managed with intermittent use of low-dose ICS because study participants taking daily budesonide, daily zafirlukast, or intermittent treatment with ICS and SABA (according to a symptom-based action plan) had similar improvement in morning PEF and a similarly low number of exacerbations (Boushey et al., 2005). (Boushey et al. 2005). However, other outcomes in this study were significantly better in patients taking regular versus intermittent ICS therapy (symptom-free days, prebronchodilator FEV1, airway hyperresponsiveness, and inflammatory markers) (symptom-free days, prebronchodilator FEV1, airway hyperresponsiveness, and inflammatory markers). Currently, data are insufficient to recommend intermittent use of ICS for most patients who have mild persistent asthma. However, it may be considered as a step-down therapy strategy for patients who are well-controlled on step 2 therapy. Further studies are needed to evaluate the use of intermittent therapy with either ICSs or leukotriene modifiers.
Step 3 Care, Long-Term Control Medications
▪ Consultation with an asthma specialist may be considered because the therapeutic options at this juncture pose a number of challenging risk/benefit considerations (Evidence D) (Evidence D). Before increasing therapy, however, the clinician should review the patient’s inhaler technique and adherence to therapy (Evidence B), as well as determine whether environmental factors, particularly allergens (Evidence A), or comorbid conditions are contributing to the patient’s worsening asthma (Evidence C) (Evidence C).
▪ Preferred step 3 care options: Two equally acceptable options are available, given the consideration of both benefits and risks for each.
— Add a LABA to a low dose of ICS (Evidence A) (Evidence A). Studies on LABAs as adjunctive therapy have revealed both benefit and some risk. See “Component 4: Medications,” section on “Safety of Long-Acting Beta2-Agonists,” for a complete discussion. In summary: \s♦ Studies demonstrate the addition of a LABA (salmeterol or formoterol) to medications for patients whose asthma is not well controlled on a low to medium dose of ICSs improves lung function, decreases symptoms, and reduces exacerbations and use of quick-relief medication in most patients who have asthma (Bateman et al. 2004; EPR—2 1997; Greenstone et al. 2005; Masoli et al. 2005). See also Evidence Table 11: Inhaled Corticosteroids—Combination Therapy. \s♦ A large clinical trial comparing daily treatment with salmeterol or placebo added to usual asthma therapy (Nelson et al. 2006) demonstrated an increased risk of asthma-related deaths in patients treated with salmeterol (13 deaths out of 13,176 patients treated for 28 weeks with salmeterol versus 3 deaths out of 13,179 patients treated with placebo) (13 deaths out of 13,176 patients treated for 28 weeks with salmeterol versus 3 deaths out of 13,179 patients treated with placebo). In addition, an increased number of severe asthma exacerbations were noted in the pivotal trials submitted to the FDA for formoterol approval, particularly in the higher dose formoterol arms of the trials (Mann et al. 2003). (Mann et al. 2003). Thus the FDA determined that a Black Box warning was warranted on all preparations containing a LABA. \s♦ The Expert Panel recommends that the established, beneficial effects of LABAs for the great majority of patients who have asthma not sufficiently controlled with ICS therapy alone be weighed carefully against the increased risk for potentially deleterious, although uncommon, side effects associated with the daily use of LABAs. \s♦ Therefore, the Expert Panel has modified its previous recommendation (EPR—Update 2002) and has now concluded that, for patients who have asthma not sufficiently controlled with a low-dose ICS alone, the step-up option to increase the ICS dose should be given equal weight to that of the addition of a LABA to ICS.
OR \s— Continue the ICS as monotherapy by increasing the dose to the medium-dose range (Evidence A) (Evidence A). Studies of adults in whom the dose of ICS was at least doubled demonstrate some improvements in lung function and other outcomes in those patients who have asthma not completely controlled on a low-to-medium dose of ICS, although these results are generally less effective than adding a LABA (Ind et al. 2003). (Ind et al. 2003). In the GOAL study of 3,421 patients who had uncontrolled asthma, a substantial proportion of the patients who received a dose escalation of ICS achieved well-controlled (59 percent) or totally controlled (28 percent) asthma (Bateman et al. 2004). (Bateman et al. 2004). Furthermore, a study of 2,670 patients showed similar rates of exacerbations and nighttime awakenings among the daily medium-dose ICS and daily combination low-dose (ICS/formoterol) study treatment groups (O’Byrne et al. 2005). Both studies confirm the benefits of increasing the dose of ICS (see below for further discussion on weighing the benefits and risks of different step 3 care options) (see below for further discussion on weighing the benefits and risks of different step 3 care options).
Based on review of the evidence and in consideration of the potential benefits for improvements in the asthma control domains of impairment and risk, as well as consideration of the potential for adverse effects that exist for each therapeutic option, the Expert Panel recommends that either increasing the dose of the ICS to medium dose or adding LABA to low-dose ICS is an equally acceptable step-up option for patients whose asthma is not adequately controlled on a low dose of ICS.

Overall, the results of the Expert Panel’s review of the evidence indicate that the choice one makes at this juncture of stepping up therapy should be based on which therapeutic outcome should be the focus for each individual patient: that is, the desired degree of asthma control in the domains of either impairment or risk, or both, weighed against the relative risks of side effects for the therapeutic options.

▪ For the impairment domain, adding LABA, rather than increasing the dose of ICS, more consistently results in improvements in the impairment domain (EPR—Update 2002).
▪ If the risk domain is of particular concern, then a balance of potential risks needs to be considered (See also “Component 4: Medications”). (See also “Component 4: Medications.”).
— Adding LABA to low-dose ICS reduces the frequency of exacerbations to a greater extent than doubling the dose of ICS (Masoli et al. 2005), but adding LABA has the potential risk of rare life-threatening or fatal exacerbations.
— Increasing the dose of ICS can significantly reduce the risk of exacerbations, but this benefit may require up to a fourfold increase in the ICS dose (Pauwels et al. 1997). (Pauwels et al. 1997). This may increase the potential risk of systemic effects, although within the medium-dose range the risk is small.
▪ Alternative, but not preferred, step 3 therapy is to add (listed alphabetically) an LTRA (Evidence A), theophylline (Evidence B), or zileuton (Evidence D) to low-dose ICS.
Considerations favoring one of these alternative combinations would be the patient’s lack of response to or intolerance of the side effects of the LABA if that option was tried; marked preference for oral therapy; previous demonstration of superior responsiveness to the alternative class of drug; and/or financial considerations (theophylline is the least expensive) (theophylline is the least expensive).
The addition of either LTRA, theophylline, or zileuton has produced modest improvement in lung function and some other outcomes in patients who have asthma that is not completely controlled by an ICS. The addition of theophylline, however, has not been shown to be more effective than doubling the dose of the ICS (Evans et al. 1997; Ukena et al. 1997). (Evans et al. 1997; Ukena et al. 1997). LTRAs have produced improvements in lung function and in some but not all measures of asthma control in both adults (Laviolette et al. 1999) and children (Simons et al. 2001) whose asthma is not well controlled by ICSs. When the addition of the LTRA to an ICS has been compared with doubling the dose of the ICS, similar results were observed for a number of outcome measures (Price et al. 2003). (Price et al. 2003). Direct comparisons of the addition of an LTRA or a LABA to therapy for patients whose asthma is not well controlled by ICS show significantly greater improvement in lung function and other measures of asthma control for patients receiving the LABA and ICS combination (Ram et al. 2005). (Ram et al. 2005). Because efficacy data are limited for zileuton as add-on therapy (Dahlen et al. 1998; Lazarus et al. 1998), and zileuton requires monitoring of liver function tests, the Expert Panel considers zileuton a less desirable alternative than LTRA or theophylline for step 3 add-on therapy.
▪ If an alternative, but not preferred, treatment is initially administered and does not lead to improvement in asthma control, discontinue it and use a preferred step 3 option before stepping up to step 4 (Evidence D) (Evidence D).
Step 4 Care, Long-Term Control Medications
▪ The preferred option is to increase the dose of ICS to the medium-dose range AND add a LABA (Evidence B) (Evidence B). This step is recommended for patients who have asthma not controlled by step 3 therapy. This approach is also recommended for those patients who experience recurring severe exacerbations requiring oral prednisone, ED visits, or hospitalizations. In a 1-year trial of combination therapy, the addition of a LABA to either low-dose or high-dose ICS significantly reduced both mild and severe exacerbation (Pauwels et al. 1997). (Pauwels et al. 1997). In addition, fewer exacerbations occurred in the group receiving high-dose ICS compared with the group receiving the lower dose, although statistical analysis was not done. See also the discussion on LABA and combination therapy in “Component 4: Medications.”
▪ Alternative, but not preferred, step 4 therapy includes medium-dose ICS AND either LTRA or theophylline (Evidence B), or zileuton (Evidence D) (Evidence D).
▪ If the add-on therapy initially administered does not lead to improvement in asthma control, discontinue it and consider a trial of a different add-on therapy before stepping up (Evidence D) (Evidence D).
Step 5 Care, Long-Term Control Medications
▪ High-dose ICS and LABA is the preferred treatment (Evidence B) (Evidence B).
▪ Omalizumab may be considered at this step for patients who have sensitivity to relevant perennial allergens (e.g., dust mites, cockroach, cat, or dog) (Evidence B) (Bousquet et al. 2004; Humbert et al. 2005). (Bousquet et al. 2004; Humbert et al. 2005).
▪ Clinicians who administer Omalizumab are advised to be prepared and equipped for the identification and treatment of anaphylaxis that may occur, to observe patients for an appropriate period of time following each omalizumab injection (the optimal length of the observation is not established), and to educate patients about the risks of anaphylaxis and how to recognize and treat it if it occurs (e.g., using prescription auto injectors for emergency self-treatment, and seeking immediate medical care) (FDA 2007). (FDA 2007).
▪ Consultation with an asthma specialist is recommended for patients who require this step of therapy (Evidence D) (Evidence D).
Step 6 Care, Long-Term Control Medications
▪ Add oral corticosteroids to step 5 therapy. Patients who are not controlled on step 5 therapy may require regular oral corticosteroids to achieve well-controlled asthma (EPR—2 1997).
— Two studies have examined the benefit of LTRA as adjunctive therapy in patients who have asthma that is not controlled by ICS and LABA. One 2-week study found no benefit for the addition of an LTRA to high-dose ICS and, for most patients in the study, another medication (either theophylline, a LABA, oral corticosteroid, or a combination) (Robinson et al. 2001). (Robinson et al. 2001). Nathan et al. (2005) reported that adding montelukast for patients who had mild or moderate persistent asthma treated with combined fluticasone (100 mcg)–salmeterol did not improve asthma outcome compared to adding placebo. Studies are not available of other long-term control medications added to the combination of medium- to high-dose ICS and LABA in severe persistent asthma. These data are not definitive; therefore, due to the side effects associated with chronic oral corticosteroid therapy, before maintenance prednisone therapy is initiated, the following may be considered: a 2-week course of oral corticosteroids to confirm reversibility; or a combination of high-dose ICS + LABA + trial of either LTRA, low-dose theophylline, or zileuton (Evidence D). \s— For patients who require long-term systemic corticosteroids:
♦ Use the lowest possible dose (single dose daily or on alternate days) (single dose daily or on alternate days).
♦ Monitor patients closely for corticosteroid adverse side effects (See “Component 4: Medications”). (See “Component 4: Medications.”).
♦ When well-controlled asthma is achieved, make persistent attempts to reduce systemic corticosteroids. High-dose ICS therapy is preferable to oral systemic corticosteroids because ICSs have fewer systemic effects. \s♦ Consultation with an asthma specialist is recommended.
SPECIAL ISSUES FOR ADOLESCENTS
The Expert Panel recommends that the pharmacologic management of asthma in school-age children and adolescents follows the same basic principles as those for adults, but the special circumstances of school and social development require special consideration (EPR—2 1997).

Assessment Issues
The Expert Panel recommends that pulmonary function testing should be performed by using comparison data from an appropriate reference population (ATS 1995; EPR—2 1997). Adolescents generally compare better to childhood norms than to adult predicted norms. Testing in a laboratory or clinic that specializes in children can result in higher pulmonary function values and more consistent data. Technicians who conduct pulmonary function testing for children should have special training in achieving the best possible effort from young patients.

Treatment Issues
The Expert Panel recommends that adolescents (and younger children as appropriate) be directly involved in developing their written asthma action plans (See “Component 2: Education for a Partnership in Asthma Care”). (See “Component 2: Education for a Partnership in Asthma Care.”). Adolescents may experience more difficulties than younger children in adhering to a medication plan because they may fail to recognize the danger of poorly controlled asthma (Strunk et al. 1985), they may not accept having a chronic illness, or they may view the plan as infringing on their emerging independence and adulthood. In teaching adolescents the same asthma self-management techniques expected of adults, the clinician should address adolescent developmental issues, such as building a positive self-image and confidence, increasing personal responsibility, and gaining problem-solving skills. To accomplish this approach, it is often helpful to see the adolescent initially without parents present and to involve the adolescent directly in setting goals for therapy, developing an appropriate asthma action plan, and reviewing the effectiveness of the plan at repeated visits. The parents can be brought in at the end of the visit to review the plan together and to emphasize the parents’ important role in supporting the adolescent’s efforts.

School Issues
The Expert Panel recommends that the clinician prepare a written asthma action plan for the student’s school. Either encourage the youth or the parents to take a copy of the plan to the youth’s school or obtain parental permission and send a copy to the school nurse or designee (Evidence C) (Evidence C). The written asthma action plan should include the following information: instructions for handling exacerbations (including the clinician’s recommendation regarding self-administration of medication); recommendations for long-term control medications and prevention of EIB, if appropriate; and identification of those factors that make the student’s asthma worse, so the school may help the student avoid exposure. For a sample plan, See “Asthma Care,” figure 3-21.

It is preferable to schedule daily, long-term medications so that they are not taken at school, even if this results in unequal dosing intervals throughout the day. In school districts that have more comprehensive school nurse coverage, however, youths who would benefit from close supervision to promote adherence may be given medications at school. In this way, daily medication can be administered, and patient education can be supplemented most days of the week.

Students who have asthma often require medication during school to treat acute symptoms or to prevent EIB that may develop during physical education class, school recess, or organized sports. Reliable, prompt access to medication is essential, but it may be difficult because of school rules that preclude the student from carrying medications. The NAEPP and several member organizations have adopted resolutions that endorse allowing students to carry and self-administer medications when the physician and parent consider this appropriate. It may be helpful for some children to have a compressor-driven nebulizer available at the school.

Sports Issues
The Expert Panel recommends that clinicians encourage full participation in physical activities; physical activity at play or in organized sports is an essential part of a child’s life (EPR—2 1997). When children with asthma exercise, many of them cough, wheeze, or become extremely tired. EIB is usually prevented by treatment immediately before vigorous activity or exercise. If symptoms occur during normal play activities, long-term therapy should be increased. Poor endurance, also known as EIB, can be an indication of poorly controlled persistent asthma; proper long-term control medication use can reduce EIB (See “Exercise-Induced Bronchospasm.”). Only as a last resort should activity be limited or curtailed.

SPECIAL ISSUES FOR OLDER ADULTS Evaluation Issues
Because of the high prevalence of other obstructive lung disease (e.g., chronic bronchitis, emphysema) among the elderly, the Expert Panel recommends determining the extent of reversible airflow obstruction (EPR—2 1997). Because the precise cause of severe airflow obstruction in older asthma patients can be difficult to identify, careful evaluation is required. A 2- to 3-week trial of systemic corticosteroid therapy can aid in detecting the presence of significant reversibility of the airway disease. Asthma medication for long-term control can then be prescribed.

Treatment Concerns
Because asthma medications may have increased adverse effects in the elderly patient, the Expert Panel recommends that therapy be adjusted (EPR—2 1997).

Although this has not been proven, airway response to bronchodilators may change with age. Patients over the age of 65, particularly those with preexisting ischemic heart disease, may be more susceptible to beta2-agonist side effects such as tremor and tachycardia. Concurrent use of an anticholinergic and a SABA may benefit the elderly patient (Barros and Rees 1990; Gross et al. 1989; Ullah et al. 1981).
Theophylline clearance is reduced in elderly patients (Nielsen-Kudsk et al. 1988), resulting in increased theophylline blood levels. Furthermore, age is an independent risk factor for developing life-threatening events from iatrogenic chronic theophylline overdose (patients 75 years or older have a 16-fold higher risk of death from theophylline overdose than patients 25 years of age) (Shannon and Lovejoy 1990). Because of the increased use of medications in this age group, the risk of drug interaction is higher, particularly with antibiotics and H2-histamine antagonists like cimetidine. Theophylline and epinephrine can aggravate pre-existing heart conditions.
Corticosteroids in the system can cause confusion, agitation, and changes in glucose metabolism.
Corticosteroid inhalation. In patients with osteoporosis risk factors or low bone mineral density, consider concurrent treatments with calcium supplements, vitamin D, and bone-sparing medications (e.g., bisphosphonates) (Evidence D). Elderly patients may be more at risk due to preexisting osteoporosis, changes in estrogen levels that affect calcium utilization, and a sedentary lifestyle. The risk of not adequately controlling asthma is that it will limit the patient’s mobility and activities unnecessarily (See “Component 4: Medications.”). The use of bone densitometry when treatment begins and again 6 months later is one method for identifying patients at risk for accelerated bone loss from high-dose ICS therapy (NHLBI 1996), though the benefits of this method have not yet been tested in clinical trials.
Because some medications may aggravate asthma, the Expert Panel recommends that medications used to treat other diseases and conditions be adjusted as needed (EPR—2 1997). Nonsteroidal anti-inflammatory drugs used to treat arthritis, beta-blockers used to treat hypertension (particularly nonselective beta-blockers), and beta-blockers found in some glaucoma eye drops may aggravate asthma. See “Component 4: Medications” for more information on medications that can complicate asthma management.

The Expert Panel recommends that the patient’s technique for using medications and devices be reviewed (Evidence B). Technique for using inhaler devices, peak flow meters, and spirometry is especially important in the elderly because physical (e.g., arthritis) and cognitive (recognized or unrecognized) impairments can make acquisition and retention difficult.
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