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Asthma: Helping Patients Breathe Easier

Posted on: Friday, 12 November 2004, 03:00 CST

Asthma is a chronic inflammatory airway disease characterized by wheezing, breathlessness, chest tightness, and coughing principally at night or in the early morning.1 Symptoms often are associated with widespread but variable airflow obstruction that can be reversed spontaneously or with treatment. The inflammation also can cause an increase in bronchial hyperresponsiveness to various stimuli.1 According to the American Lung Association, approximately 20 million Americans had symptoms of asthma in 2001.2 Asthma accounted for an estimated 10.4 million physician office visits, 1.8 million emergency department visits, and nearly 4,500 deaths in 2000.3 Asthma incurs considerable economic costs,4 and the physical and emotional burden of asthma can be significant, even for those patients with mild disease.5 Adherence to a guidelines-based treatment approach can greatly reduce the significant morbidity and associated health resources used due to asthma.67

In 2002, the National Asthma Education and Prevention Program's (NAEPP) Expert Panel provided an evidence-based update to the 1997 National Heart, Lung, and Blood Institute Guidelines for the Diagnosis and Management of Asthma. The 2002 update includes recommendations for the pharmacologie treatment, monitoring, and prevention of asthma. Joint recommendations for the management of asthma in pregnant women were issued by the American College of Allergy, Asthma, and Immunology (ACAAI) and the American College of Obstetricians and Gynecologists (ACOG) in 2000.

* Classification of Asthma Severity

The 1997 Guidelines for the Diagnosis and Management of Asthma defined a stepwise approach to the pharmacologic treatment of asthma based on severity. Four severity steps from mild-intermittent (Step 1) to severe-persistent (Step 4) are defined based on clinical features before treatment. Classification of disease severity in children 5 years or younger is based on symptoms, whereas classification in older patients is based on symptoms and pulmonary function.' Forced expiratory volume in 1 second (FEV^sub 1^) and peak expiratory flow (PEF) are the most common measures of pulmonary function. FEV^sub 1^ measures the volume of air in the first second of a forced exhalation maneuver after a deep inspiratory effort. At an early phase of forced expiration, the expiratory flow achieves maximal values. The highest flow is known as the peak expiratory flow rate (PEFR). Both measures are effort-dependent and can be performed in children as young as 4 years.

Patient asthma severity is designated by the most severe symptom or objective measure. For example, a patient with daily daytime symptoms would be classified with moderate-persistent disease despite pulmonary function and nighttime symptoms consistent with mild disease (i.e. FEV^sub 1^ ≥ 80%, PEF variability 20% to 30%, and nighttime symptoms ≤1 night per week). Based on patient-reported symptoms, most patients can be classified as having mild to moderate disease. In a recent survey of 2,509 adults and children with asthma based on symptoms, 40% of patients had mild- intermittent disease, 22% had mild-persistent disease, and 19% had moderate-persistent disease.8

* Pharmacologie Treatment of Asthma

Two medication types (controller and reliever) are used to treat patients with asthma. Long-term controller medications are used on a daily basis in patients with persistent asthma to achieve and maintain control of symptoms.1 The most effective controller medications are those that reduce inflammation.1 Reliever medications are used as needed for the quick relief of asthma symptoms.1 Reliever medications such as short-acting beta^sub 2^- adrenergic agonists (SABAs) provide symptom relief by alleviating airway obstruction and associated bronchoconstriction.1

Long-term controller treatment is recommended for adults and children with any severity of persistent asthma.9 Because asthma progression may occur more readily in very young children, it is especially important to consider controller treatment for symptomatic children younger than 5 years and likely to develop persistent disease.9 The diagnosis of asthma in these patients maybe difficult. However, new criteria for the use of controller treatment in very young children with symptoms of asthma are based in part on the likelihood of developing persistent disease.9 When choosing a long-term treatment, medication effectiveness, patient response to previous regimens, patient or family ability to correctly administer the medication, and anticipated adherence should be considered.9

* Mild-Intermittent Asthma

Recommendations for the treatment of patients with mildintermittent asthma have not changed from those of the 1997 guidelines. Controller medications are not recommended in these patients. Short-acting beta^sub 2^-adrenergic agonists are recommended as needed for symptom relief, but overuse indicates poor asthma control and the need to reconsider disease severity. For example, patients classified with intermittent asthma who use a SABA more than two times a week may need to initiate long-term controller treatment, consistent with a diagnosis of persistent disease.

* Mild-Persistent Asthma

As in earlier guideline recommendations, the 2002 NAEPP update recognizes the need for controller therapy in patients with mild-to- severe persistent asthma. The Expert Panel specifically addressed the effectiveness of ICS controller therapy versus as-needed SABAs in children with persistent disease. Evidence supporting the use of ICSs was obtained from six studies conducted in children 5 years and older10-15 and two studies in younger children.16-17 The studies demonstrated improved lung function and asthma control with ICSs and reduced need for emergency intervention compared with as-needed SABA therapy. The most robust evidence for the superiority of ICSs was obtained from the Childhood Asthma Management Program (CAMP) Research Group Study.11 The CAMP study assessed the effectiveness of inhaled budesonide and nedocromil versus placebo over 4 to 6 years in 1,041 children 5 to 12 years old.

An important change regarding the choice of controller medications for mild-persistent asthma in adults and children are recommendations for the preferred use of ICSs in all age groups. Panel recommendations favoring the use of ICSs over other controller therapies, including leukotriene receptor antagonists (LTRAs), are based on evidence showing greater efficacy of ICSs.9,11,18-20

Leukotriene modifiers are the newest class of asthma controller medications. These agents, which include the leukotriene receptor antagonists zafirlukast and montelukast, and the 5-lipoxygenase inhibitor zileuton, are available in tablet form. Leukotriene modifiers likely exert their anti-asthma effects by inhibiting the role that leukotrienes play in bronchoconstriction, mucosal edema caused by vascular leakage, mucus secretion, and infiltration of inflammatory cells.21 Although leukotriene modifiers demonstrate anti-inflammatory activity, the degree of activity is less than that shown with ICSs.22 Of note among leukotriene modifiers in terms of safety is an association between zileuton and elevated liver function tests.23 These abnormalities in liver function tests may progress, remain unchanged, or resolve with continued treatment. It is recommended that hepatic traiisaminases be assessed at initiation of therapy with zileuton and during treatment. Treatment should be discontinued in patients showing clinical evidence of liver dysfunction or transaminase elevations > 5 times the upper limit of normal.23

Studies of leukotriene modifiers reviewed by the Expert Panel18- 24-34 were conducted largely in patients with mild- or moderate- persistent asthma. These studies demonstrated statistically significant improvements in daytime and nighttime asthma symptoms, quality of life, pulmonary function, and decreased use of reliever medications with leukotriene modifier treatment. Nonetheless, the panel concluded that improvements were modest. Differences in the extent of leukotriene production in patients with allergic asthma may account for a variable clinical response to these agents.35

Greater efficacy of ICSs versus leukotriene modifiers was shown in a study by Busse et al.18 In this study, patients older than 15 years with persistent asthma who remained symptomatic while using a SABA were randomized to treatment with low-dose fiuticasone propionate (88 meg twice daily) or montelukast (10 mg once daily) for 24 weeks. In this patient population, the ICS fluticasone provided significant improvements in asthma symptom scores, nighttime awakenings due to asthma, need for reliever medication, and pulmonary function. Moreover, fluticasone increased the percentage of days without symptoms significantly compared with montelukast.18

Stepwise Approach for Managing Infants and Young Children (≤ 5 Years) With Acute or Chronic Asthma

A recent study by O'Byrne et al conducted in corticosteroid- naive patients at least 12-years-old with mild-persistent asthma supports the guideline recommendations for ICSs alone as first-line therapy in mild-persistent dis ease. The study demonstrated efficacy of monotherapy with the ICS budesoni\de. In this patient population, compared with placebo, budesonide reduced the risk of poorly controlled asthma days by 48% and severe exacerbations by 60%.36 The additional use of a long-acting beta^sub 2^-adrenergic agonist (LABA) increased lung function, but conferred no greater protection in terms of asthma control.

For children 5 years and younger with mild-persistent asthma, the use of low-dose ICS monotherapy is also preferred ( sec Table: "Stepwisc Approach for Managing Infants and Young Children ≤ 5 years with Acute or Chronic Asthma"). ICSs approved for use in children younger than 5 years include fluticasone dry-powder inhaler (approved for children as young as 4 years) and nebulized budesonide (approved for children as young as 12 months). Although approved by the PDA for use in preschool-aged children, fluticasone dry-powder inhaler (Flovent Diskus, GlaxoSmithKline) is not yet commercially available.

Cromolyn sodium has been used extensively in the past, and remains in use because of its long-standing safety profile in children. Moreover, the availability of cromolyn for nebulization therapy was an advantage for young children lacking the coordination or inspiratory flow rates necessary for correct use of conventional metered-dosc or dry-powder inhalers. Among ICSs, only budesonide is currently available for nebulization therapy in infants and young children.

Because cromolyn was recognized as generally less effective than ICSs, earlier guideline recommendations for the use of cromolyn in young children were limited to those children with mild disease. More recently, greater asthma control with ICSs versus nedocromil was shown in the CAMP study." Nebulized budesonide (Pulmicort Respules, AstraZeneca LP) was also significantly more effective than nebulized cromolyn in children 2 to 6 years of age with persistent asthma.37,38 Greater efficacy of ICSs compared with nedocromil and minimal efficacy of cromolyn shown in a recent meta-analysis by Tasche et al,20 along with evidence of long-term safety of ICS use in children, prompted the removal of cromolyn and nedocromil from preferred status in the treatment of infants and young children with mild-persistent asthma. According to the 2002 update, cromolyn is no longer considered first-line therapy for mildpersistent asthma in preschool-aged children, and nedocromil has been removed altogether from the list of recommended controllers.

In young children, LTRAs also provide only modest improvement in asthma outcomes.9 Long-term placebo-controlled studies like the CAMP trial that directly compare LTRAs with ICSs are lacking in children, but extrapolation of data from adults has led to recommendations for the use of LTRAs as alternatives to long-term ICS therapy for mild- persistent asthma in preschool-aged children.9 The LTRA zafirlukast is approved for use in children aged 5 years and older. Montelukast is approved for children as young as 1 year of age.

* Moderate-Persistent Asthma

Low- to medium-dose ICSs plus a LABA is the preferred controller therapy for adults and children older than 5 years of age with moderate-persistent asthma ( see Figure: "Stepwise Approach for Managing Asthma in Adults and Children > 5 years"). Increasing ICS doses within the medium-dose range or substituting a leukotriene modifier or theophylline for the LABA are considered alternative treatments. If needed, medium-dose ICSs can be used in combination therapy, preferably with a LABA.9

LABAs include formoterol fumarate and salmeterol xinafoate. Formoterol and salmeterol are approved for use in patients ≥5 and ≥4 years of age, respectively. Both medications are effective, but there are differences. For example, although formoterol and salmeterol sustain bronchodilatation for at least 12 hours after inhalation, formoterol has a more rapid onset of action.39

Recommendations for controller therapy in children 5 years and younger with moderate-persistent asthma include the use of medium- dose ICSs or low-dose ICSs plus a LABA. LTRAs and theophylline are considered alternative add-on therapies to low-dose ICSs in these patients.9 Recommendations for ICS/LABA combination therapy in children 5 years and younger have been extrapolated from data in older children and adults.9 The only ICS/LABA combination product currently available in the United States (Advair Diskus, GlaxoSmithKline) is approved for use in children 4 years of age and older. This product contains the ICS fluticasone in combination with salmeterol for administration via dry-powder inhaler. Three different Advair Diskus inhalers are available, each providing a different ICS dose in combination with salmeterol. A combination of budesonide and formoterol in a single inhaler is currently available in Europe and other countries.

Stepwise Approach for Managing Asthma in Adults and Children > 5 Yrs: Treatment

Estimated Comparative Daily Dosages for Inhaled Corticosteroids

* Severe-Persistent Asthma

The 1997 recommendations for the treatment of severe-persistent asthma have not changed. High-dose ICSs plus a LABA is the preferred therapy in children and adults. The use of systemic corticosteroids is recommended when necessary to maintain disease control. The use of oral corticosteroids should be limited and, when possible, oral corticosteroids should be tapered with attempts to maintain asthma control with high-dose ICSs.9 There is a lack of evidence supporting the addition of another controller to ICS/LABA combination therapy to avoid oral corticosteroid use.9

* Children and Pregnant Women

Findings of the 2002 NAEPP Expert Panel support the safety of long-term ICSs in children, when used at recommended doses ( see Tables: "Estimated Comparative Daily Dosages for Inhaled Corticosteroids" and "Usual Dosages for Long-Term Control Medications").9 In terms of growth, the panel highlighted the data of Agertoft and Pedersen showing no effect of inhaled budesonide on final adult height after a mean treatment duration of 9.2 years.40 Shorter-term studies evaluating the effects of ICSs on growth show an average reduction in growth velocity of 1 centimeter in the first year of treatment. Initial reductions in growth velocity seen with budesonide in the CAMP study did not last throughout the 4- to 6- year treatment period.9 Based on observations of only transient growth reduction and attainment of final adult height with long- term budesonide and additional retrospective growth data for inhaled beclomethasone, the Expert Panel determined that ICSs as a class are free of significant long-term adverse growth effects.9,11 According to the panel, any small risk of growth delay with ICSs is well balanced by their effectiveness.9

There is strong evidence from studies monitoring children for up to 6 years that long-term ICS use is also safe in terms of adrenal function, bone mineral density, and ocular effects.9 Although the panel concluded that low- to medium-dose ICSs are not associated with clinically significant suppression of adrenal function, they did note that some children may be at higher risk for adverse adrenal effects at recommended ICS doses.9

Usual Dosages for Long-Term Control Medications

Uncontrolled asthma during pregnancy may lead to adverse perinatal outcomes. Accordingly, the National Asthma Education Program Report of the Working Group on Asthma and Pregnancy emphasized the need for aggressive asthma management with daily controller therapy in women who are pregnant or likely to become pregnant.41 The use of controller medications during pregnancy was not addressed in the 2002 NAEPP update, but was discussed in the 2000 joint position statement of the ACOG and ACAAI. In their position statement, the colleges recommended the use of cromolyn as first-line therapy for pregnant women with mild-persistent asthma, reserving ICS use for women with moderate- to severe-persistent disease and mild-persistent disease inadequately controlled with cromolyn.42 In recent guidelines for the management of asthma during pregnancy, however, the NAEPP recommends ICSs as the preferred controller treatment for all severities of persistent asthma during pregnancy.43 Data from the Swedish Medical Birth Registry44,45 demonstrating the safety of in utero exposure to inhaled budesonide resulted in the FDA change of budesonide from a Pregnancy Category C to Pregnancy Category B, making budesonide the only ICS with a Pregnancy B rating. Greater efficacy of ICSs versus cromolyn evident in the NAEPP update and the Pregnancy Category B rating for budesonide support the preferred use of this ICS for all severities of persistent asthma during pregnancy.

* Early ICS Therapy

Early intervention with controller medication may have the potential to prevent or modify disease progression. The Expert Panel determined that current evidence is insufficient to determine whether early ICS intervention would have an effect on asthma progression. Preliminary results of early intervention in asthma come from the recent multinational START study (Inhaled Steroid Treatment As Regular Therapy in Early Asthma) conducted in 7,165 corticosteroid-naive patients aged 5 to 66 years with recent-onset mild-persistent asthma.46 These results show significant improvement in asthma control, with reduced risk of severe and life-threatening exacerbations over 3 years of treatment with once-daily inhaled budesonide. Improvements in prebronchodilator and postbronchodilator FEV^sub 1^ were significant over the treatment period, but were greatest during the first year.

* Monitoring Asthma

Specific parameters have been developed to monitor asthma and ensure that the goals of asthma treatment are achieved. A key component of asthma monitoring is patient self-assessment.9 Patients can assess asthma control through the use of a daily diary and monitoring symptoms and peak flow.1 Written action plans provide patients with an algorithm for makingadjustments to treatment regimens when needed. The use of written action plans has previously been recommended by the NAEPP. The value of written action plans was reviewed in the 2002 update.

The Expert Panel considered seven studies that compared asthma management using a peak flow meter-based action plan to medical management without such a plan.9 Five studies reported no differences in outcomes, but outcomes in the remaining two studies favored use of a written plan using peak flow measurements. The panel also considered a review of 25 studies of self-management interventions that demonstrated reduced hospitalizations and emergency department visits with the use of a written action plan, and better lung function in patients who ad justed their own medications according to a written action plan compared with patients whose medications were ad justed at regular care visits. Based on the evidence, the panel recommended the use of a written action plan, especially for patients with moderate- to severe- persistent asthma or a history of severe exacerbations.9 The panel was unable to determine the relative effectiveness of peak flow- versus symptom-based action plans; nonetheless, peak flow monitoring should be considered in patients with moderate- or severe- persistent asthma to predict exacerbations, evaluate response to therapy modification, categorize severity of exacerbations, and measure impairment.9

ACKNOWLEDGEMENTS

The authors thank Leslie Sell, PhD, for support in the preparation of this manuscript.

DISCLOSURE

The authors have disclosed that this review was funded by AstraZeneca LP.

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Asthma: Helping Patients Breathe Easier

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Long-term controller treatment is recommended for adults and children with any severity of persistent asthma.

Among ICSs, only budesonide is currently available for nebulization therapy in infants and young children.

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19. Reed CE, Offord KP, Nelson HS, et al: Aerosol beclomethasone dipropionate spray compared with theophylline as primary treatment for chronic mild or moderate persistent asthma. J Allergy Clin Immunol 1998;101(1 Pt 1):14-23.

20. Tasche MJA, Uijen JHJM, Bernsen RMD, et al: Inhaled disodium cromoglycate (DSCG) as maintenance therapy in children with asthma: a systematic review. Thorax 2000;55(11):913-20.

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22. Bisgaard H: Leukotriene modifiers in pediatrie asthma management. Pediatrics 2001;107:381-90.

23. Zyflo Filmtab Product Information. Abbott Laboratories. Chicago, IL. 2003.

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30. Knorr B, Franchi LM, Bisgaard H, et al: Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics 2001;108:e48-57. Available at: http://www.pediatrics.org/ cgi/content/full/108/3/ e48.

31. Nathan RA, Bernstein JA, Bielory L, et al: Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction. J Allergy Clin Immunol 1998;1\12:935-42.

32. Pearlman DS, Lampl KL, Dowling PJ Jr, et al. Effectiveness and tolerability of zafirlukast for the treatment of asthma in children. Clin Ther 2000;22:732-47.

33. Schwartz HJ, Petty T, Dub LM, et al: A randomized controlled trial comparing zileuton with theophylline in moderate asthma. Arch Intern Med 1998;158:141-8.

34. Tashkin DP, Nathan RA, Howland WC, et al: An evaluation of zafirlukast in the treatment of asthma with exploratory subset analyses. J Allergy Clin Immunol 1999;103:246-54.

35. Hasday JD, Meltzer SS, Moore WC, et al: Anti-inflammatory effects of zilcuton in a subpopulation of allergic asthmatics. Am J Respir Grit Care Meet 2000;161:1229-36.

36. O'Byrne PM, Barnes PJ, Rodriguez-Roisin R, et al: Low dose inhaled budesonide and formoterol in mild persistent asthma: The OPTIMA randomized trial. Am J Respir Grit Care Med 2001;164(8 Pt l):1392-7.

37. Leflcin JG, Szefler SJ, Murphy KR, et al: Nebulized budesonide inhalation suspension compared with cromolyn sodium nebulizer solution for asthma in young children: Results of a randomized outcomes trial. Pediatrics 2002;109(5):866-72. Available at: http://www.pediatrics.org/cgi/content/ full/112/3/c212.

38. Murphy KR, Fitzpatrick S, Cruz-Rivera M, et al: Effects of budesonide inhalation suspension compared with cromolyn sodium nebulizer solution on health status and caregiver quality of life in childhood asthma. Pediatrics 2003;! 12:e212-9. Available at http:// www.pediatrics.Org/cgi/content/full/l 12/3/e212.

39. Lotvall J: Pharmacological similarities and differences between beta2-agonists. Respir Med 2001;95:S7-S11.

40. Agertoft L, Pedersen S: Effect of long-term treatment with inhaled budesonide on adult height in children with asthma. N Engl J Med 2000;343(15):1064-9.

41. National Asthma Education Program (NAEP) : Report of the Working Group on Asthma and Pregnancy: Management of Asthma During Pregnancy. Bethesda, Md.: National Heart, Lung, and Blood Institute; National Institutes of Health, 1993. Publication 96-141593.

42. American College of Obstetricians and Gynecologists (ACOG) and the American College of Allergy, Asthma and Immunology (ACAAI) : The use of newer asthma and allergy medications during pregnancy. Ann Allergy Asthma Immunol2000;84(5):475-80.

43. National Asthma Education and Prevention Program. NAEPP Expert Panel Report: Managing Asthma During Pregnancy: Recommedations for the Pharmacologie Treatment of Asthma Update 2004. Bethesda, MD. National Heart, Lung, and Blood Institute; National Institutes of Health; 2004. Publication 64-5246.

44. Klln B, Rydhstroem H, berg A: Congenital malformations after the use of inhaled budesonide in early pregnancy. Obstet Gynecol 1999;93(3):392-5.

45. Ericson A, Klln B: Use of drugs during pregnancy-unique Swedish registration method that can be improved. Information From the Swedish Medical Products Agency 1999; 1:8-11.

46. Pauwels RA, Pedersen S, Busse WW, et al: Early intervention with budesonide in mild persistent asthma. Lancet 2003;361(9363):1071-6.

Kevin R. Murphy, MD

Beth Cecil, MSN, APRN, FNP, CCRC

Nancy L. Server, MSN, APRN, FNP, CCRC

ABOUT THE AUTHORS

Dr. Murphy is a Pediatric Pulmonologist at Midwest Allergy and Asthma Clinic, Omaha, Neb. Beth Cecil and Nancy Sarver are Nurse Practitioners.

Copyright Springhouse Corporation Oct 2004

Source: Nurse Practitioner

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