National Institutes of Health (NIH) NAEPP 2007 Asthma Guideline UPDATE Susan K. Ross RN, AE-C MDH Asthma Program 651-201-5629 Susan.Ross@health.state.mn.us 1 National Institutes of Health National Asthma Education Prevention Program (NAEPP) 2007 Guidelines for the Diagnosis and Management of Asthma (EPR-3) http://www.nhlbi.nih.gov/guidelines/asthma/index.htm National Asthma Education and Prevention Program 2 School Nurses “School nurses are an important component of the health care system for children and play a critical role in identifying solutions to the health problems faced by today’s children and families”. The Journal of School Nursing, June 2007, Vol.23, Num. 3 3 What Is Asthma? “Asthma is a common chronic disorder of the airways that involves a complex interaction of airflow obstruction, bronchial hyperresponsiveness and an underlying inflammation. This interaction can be highly variable among patients and within patients over time”. 2007 NAEPP Guidelines, EPR 3- Section 2, p 12. 4 Characteristics of Asthma • Airway Inflammation • Airway Obstruction (reversible) • Hyperresponsiveness (irritability of airways) 5 Normal & Asthmatic Bronchiole 6 Why Do We Need Asthma Guidelines? 7 Asthma: Accounts for 12.8 million lost school days annually 67% of US children with asthma have had at least one attack in the past year 1 (2005) Is the 3rd leading cause of hospitalizations among children under 15 2 Close to 1 in 11 (8.9%) children have asthma 1 6.5 million children under 18 have asthma (2003) (2005) 1 National Health Interview Survey; Asthma Prevalence, Health Care Use, and Mortality, 2000-01, National Center for Health Statistics, CDC 2 National Hospital Discharge Survey, 2002; American Lung Association Asthma and Children Fact Sheet, August 2006 1 8 1 Asthma Prevalence Age Current asthma prevalence (%) Deaths per 1,000,000 2004-2005 0-4 yrs 6.2 2.0 5-10 yrs 9.3 2.3 11-17 yrs 10.0 3.3 Total 8.7 2.6 Adapted from Akinbami L. Advance Data 2006 9 This means.. In a class of 30 children, you can expect 2 to 3 students WILL have asthma This number will vary depending on age and geographical location 10 “Children & Asthma In America” Survey - 2004 The Children and Asthma in America survey focused on children 4 to 18 years of age with asthma, which represents about 5.8 million children in the country based on figures from the 2002 National Health Interview Survey. A survey of a national probability sample of 801 children 4 to 18 years of age who currently have asthma, conducted from February to May 2004. The survey found that nearly 1 out of 10 (9.2%) American children 18 years of age and younger currently suffer from asthma. The Children and Asthma in America survey concludes that a significant number of children with asthma do not have their condition under control, falling far short of national treatment goals. Excerpts taken from www.asthmainamerica.com, “Children & Asthma in America”, 2004 Glaxo-SmithKline 11 2007 - Guidelines For The Diagnosis & Management Of Asthma Expert Review Panel (EPR-3) 12 Asthma Guidelines: History and Context Initial guidelines released in 1991 and updated in 1997 Updated again in 2002 (EPR-2) with a focus on several key questions about medications, monitoring and prevention. – Long-term management of asthma in children – Combination therapy – Antibiotic use – Written asthma action plans (AAP) and peak flow meters (PFM) – Effects of early treatment on the progression of asthma 13 Old and New Asthma Guidelines: What Has NOT Changed Initial asthma therapy is determined by assessment of asthma severity. – Ideally, before the patient is on a long-term controller. Stepping therapy up or down is based on how well asthma is controlled or not controlled . Inhaled corticosteroids (ICS) are the preferred first-line therapy for asthma. Systemic steroids can still be used to treat asthma exacerbations. Peak flows and written asthma action plans are recommended for asthma self management . – Especially in moderate and severe persistent asthma, or those with a history of severe exacerbations or poorly controlled asthma. 14 Asthma Therapy Goals “The goal of asthma therapy is to control asthma so patients can live active, full lives while minimizing their risk of asthma exacerbations and other problems” Dr. William Busse, MD., chairman of the NAEPP EPR -3 15 2007 - Guidelines For The Diagnosis & Management of Asthma (EPR-3) (Almost) no new medications. Restructuring into “severity” and “control” . Domains of “impairment” and “risk”. Six treatment steps (step-up/step-down). More careful thought into ongoing management issues. Summarizes extensively-validated scientific evidence that the guidelines, when followed, lead to a significant reduction in the frequency and severity of asthma symptoms and improve quality of life. 16 New Strategies of the EPR-3 Summary 17 EPR-3, Page 36-38 Key Points: Definition, Pathophysiology & Pathogenesis Asthma airways. is a chronic inflammatory disorder of the The immunohistopathologic features of asthma include inflammatory cell infiltration. Airway inflammation contributes to airway hyperresponsiveness, airflow limitation, respiratory symptoms, and disease chronicity. In some patients, persistent changes in airway structure occur, including sub-basement fibrosis, mucus hypersecretion, injury to epithelial cells, smooth muscle hypertrophy, and angiogenesis. (remodeling) 18 Key Points: Continued.. Gene-by-environment interactions are important to the expression of asthma. Atopy, the genetic predisposition for the development of an immunoglobulin E (IgE)-mediated response to common aeroallergens, is the strongest identifiable predisposing factor for developing asthma. Viral respiratory infections are one of the most important causes of asthma exacerbation and may also contribute to the development of asthma. EPR 3, Section 2: Page 11 19 Key Differences from 1997 & 2002 Reports The critical role of inflammation is validated - there is considerable variability in the pattern of inflammation indicating phenotypic differences that may influence treatment responses. (in other words – genetics) Gene-by-environmental interactions are affect the development of asthma. Of the environmental factors, allergic reactions are important. Viral respiratory infections are key and have an expanding role in these processes. The onset of asthma for most patients begins early in life with the pattern of disease persistence determined by early, recognizable risk factors including atopic disease, recurrent wheezing, and a parental history of asthma. Current asthma treatment with anti-inflammatory therapy does not appear to prevent progression of the underlying disease severity. EPR 3 – section 2, p. 12 20 Causes – We Don’t Know…Yet! Asthma has dramatically risen worldwide over the past decades, particularly in developed countries, and experts are puzzled over the cause of this increase. Not all people with allergies have asthma, and not all cases of asthma can be explained by allergic response. Asthma is most likely caused by a convergence of factors that can include genes (probably several) and various environmental and biologic triggers (e.g., infections, dietary patterns, hormonal changes in women, and allergens). 21 The 4 Components Of Asthma Management - (Section 3) Component 1: Measures of Asthma Assessment and Monitoring Component 2: Education for a Partnership in Asthma Care Component 3: Control of Environmental Factors and Comorbid Conditions That Affect Asthma Component 4: Medications 22 Component 1 Measures of Asthma Assessment & Monitoring 23 Key Points - Overview: Measures Of Asthma Assessment & Monitoring Assessment and monitoring are closely linked to the concepts of severity, control, and responsiveness to treatment: – Severity - intensity of the disease process. Severity is measured most easily and directly in a patient not receiving long-term-control therapy. – Control - degree to which asthma (symptoms, functional impairments, and risks of untoward events) are minimized and the goals of therapy are met. – Responsiveness - the ease with which asthma control is achieved by therapy. EPR -3 , Pg. 36, Section 3, Component 1: Measures of Asthma Assessment and Monitoring 24 Key Points – Cont. 2 Severity & Control Are Assessed Based On 2 Domains Impairment (Present): – Frequency and intensity of symptoms – Functional limitations (quality of life) Risk (Future): – Likelihood of asthma exacerbations or – Progressive loss of lung function (reduced lung growth) – Risk of adverse effects from medication EPR -3, Pg. 38-80, 277-345 25 Key Points - Cont. 3 Severity & Control are used as follows for managing asthma: If the patient is not currently on a long-term controller at the first visit: – Assess asthma severity to determine the appropriate medication & treatment plan. Once therapy is initiated, the emphasis is changed to the assessment of asthma control. – The level of asthma control will guide decisions either to maintain or adjust therapy. 26 Key Differences: Component 1 - Overview The key elements of assessment and monitoring include the concepts of severity, control, and responsiveness to treatment: – Classifying severity for initiating therapy. – Assessing control for monitoring and adjusting therapy. – Asthma severity and control are defined under domains of impairment and risk. The distinction between the domains of impairment and risk for assessing severity and control emphasizes the need to consider separately asthma’s effects on quality of life and functional capacity on an ongoing basis and the risks it presents for adverse events in the future, such as exacerbations and progressive loss of pulmonary function. 27 Assessing Impairment (Present) Domain Assess by taking a careful, directed history and lung function measurement. Assess Quality of Life using standardized questionnaires – – – – Asthma Control Test (ACT) Childhood Asthma Control Test Asthma Control Questionnaire Asthma Therapy Assessment Questionnaire (ATAQ) control index. Some patients, appear to perceive the severity of airflow obstruction poorly. 28 Assessing Risk (Future) Domain Of adverse events in the future, especially of exacerbations and of progressive, irreversible loss of pulmonary function—is more problematic (airway remodeling). The test most used for assessing the risk of future adverse events is spirometry. 29 Measures of Assessment & Monitoring Diagnosis 30 Key Points – Diagnosis of Asthma To establish a diagnosis of asthma the clinician should determine that: Episodic symptoms of airflow obstruction or airway hyperresponsiveness are present. Airflow obstruction is at least partially reversible. Alternative diagnoses are excluded. Recommended methods to establish the diagnosis are: – Detailed medical history. – Physical exam focusing on the upper respiratory tract, chest, and skin. – Spirometry to demonstrate obstruction and assess reversibility, including in children 5 years of age or older. – Additional studies to exclude alternate diagnoses. 31 Key Differences – Diagnosis Discussions added on use of spirometry, especially in children and on criteria for reversibility. Information added on vocal cord dysfunction and cough variant asthma as alternative diagnosis. References added about conditions that complicate diagnosis and treatment. EPR -3, Sec.3, Pg. 41 32 Key Indicators: Diagnosis of Asthma Wheezing – high-pitched whistling sounds when breathing out. History of (any): – – – – Cough, worse particularly at night Recurrent wheeze Recurrent difficulty in breathing Recurrent chest tightness Symptoms occur or worsen in the presence of known triggers. Symptoms occur or worsen at night awakening patient. 33 Characterization & Classification of Asthma SEVERITY 34 Key Points - Initial Assessment: Severity Once diagnosis is established: – Identify precipitating factors (triggers). – Identify comorbidities that aggravate asthma – Assess patient’s knowledge & skills for selfmanagement. – Classify severity using impairment & risk domains. Pulmonary function testing (spirometry) to assess severity. 35 EPR -3, Sec. 3, pg. 47 Key Differences – Initial Assessment & Severity Severity class for asthma changed mild intermittent to intermittent. Severity class is defined in terms of 2 domains – impairment & risk . New emphasis on using FEV1 /FVC is added to classify severity in children because it may be a more sensitive measure than FEV1. EPR-3 Sec.3, Pg. 48 36 Assessment of Asthma Severity Previous Guidelines Frequency of daytime symptoms Frequency of nighttime symptoms Lung function 2007 Guidelines Impairment – Frequency of daytime /nighttime symptoms – Quality of life assessments – Frequency of SABA use – Interference with normal activity – Lung function (FEV1/FVC) Risk – Exacerbations (frequency and severity) 37 Classification of Asthma Severity: Clinical Features Before Treatment – 2002 “Old” Guidelines Days With Symptoms Step 4 Continuous Nights With Symptoms Frequent PEF or FEV1 60% PEF Variability 30% Severe Persistent Step 3 Daily >1night/week 60%-<80% 30% Moderate Persistent Step 2 >2/week, <1x/day >2 nights/month 80% 20-30% 80% 20% Mild Persistent 2 days/week Step 1 2/month Mild Intermittent Footnote: The patient’s step is determined by the most severe feature. NOT Currently Taking Controllers Classification of Asthma Severity (04 years of age) Components of Severity Impairment Risk Persistent Intermittent Mild Moderate Severe Symptoms 2 days/week >2 days/week but not daily Daily Throughout the day Nighttime awakenings 0 12x/month 34x/month >1x/week Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week but not daily Daily Several times per day Interference with normal activity None Minor limitation Some limitation Extremely limited Exacerbations requiring oral systemic corticosteroids 01/year 2 exacerbations in 6 months requiring oral systemic corticosteroids, or 4 wheezing episodes/1 year lasting >1 day AND risk factors for persistent asthma Consider severity and interval since last exacerbation. Frequency and severity may fluctuate over time. Exacerbations of any severity may occur in patients in any severity category. Recommended Step for Initiating Therapy (See figure 41a for treatment steps.) Step 1 Step 2 Step 3 and consider short course of oral systemic corticosteroids In 26 weeks, depending on severity, evaluate level of asthma control that is achieved. If no clear benefit is observed in 46 weeks, consider adjusting therapy or alternative diagnoses. Level of severity is determined by both impairment a & risk. Assess impairment by caregivers recall of previous 2-4 weeks. NOT Currently Taking Controllers Classification of Asthma Severity (511 years of age) Components of Severity Persistent Intermittent Mild Moderate Severe 2 days/week >2 days/week but not daily Daily Throughout the day Nighttime awakenings 2x/month 34x/month >1x/week but not nightly Often 7x/week Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week but not daily Daily Several times per day Interference with normal activity None Minor limitation Some limitation Extremely limited Symptoms Impairment • Normal FEV1 between exacerbations Lung function Risk Exacerbations requiring oral systemic corticosteroids Recommended Step for Initiating Therapy (See figure 41b for treatment steps.) • FEV1 >80% predicted • FEV1 = >80% predicted • FEV1 = 6080% predicted • FEV1 <60% predicted • FEV1/FVC >85% • FEV1/FVC >80% • FEV1/FVC = 7580% • FEV1/FVC <75% 01/year (see note) 2/year (see note) Consider severity and interval since last exacerbation. Frequency and severity may fluctuate over time for patients in any severity category. Relative annual risk of exacerbations may be related to FEV1. Step 1 Step 2 Step 3, mediumdose ICS option Step 3, medium-dose ICS option, or step 4 and consider short course of oral systemic corticosteroids In 26 weeks, evaluate level of asthma control that is achieved, and adjust therapy accordingly. NOT Currently Taking Controllers Classification of Asthma Severity 12 years of age Components of Severity Intermittent Mild Moderate 2 days/week >2 days/week but not daily Daily Throughout the day Nighttime awakenings 2x/month 34x/month >1x/week but not nightly Often 7x/week Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week Daily Several times per day Interference with normal activity None Symptoms Impairment Normal FEV1/FVC: 819 yr 85% 20 39 yr 80% 40 59 yr 75% 60 80 yr 70% >2 days/week but not daily, and not more than 1x on any day Minor limitation Some limitation Severe Extremely limited • Normal FEV1 between exacerbations Lung function Risk Persistent Exacerbations requiring oral systemic corticosteroids • FEV1 >80% predicted • FEV1 >80% predicted • FEV1 >60% but <80% predicted • FEV1 <60% predicted • FEV1/FVC normal • FEV1/FVC normal • FEV1/FVC reduced 5% • FEV1/FVC reduced >5% 01/year (see note) 2/year (see note) Consider severity and interval since last exacerbation. Frequency and severity may fluctuate over time for patients in any severity category. Relative annual risk of exacerbations may be related to FEV1. Recommended Step for Initiating Treatment (See figure 45 for treatment steps.) Step 3 Step 1 Step 2 Step 4 or 5 and consider short course of oral systemic corticosteroids In 26 weeks, evaluate level of asthma control that is achieved and adjust therapy accordingly. Classifying Severity AFTER Control is Achieved – All Ages Classification of Asthma Severity Lowest level of treatment Intermittent required to maintain control Step 1 Persistent Mild Moderate Severe Step 2 Step 3 or 4 Step 5 or 6 (already on controller) Periodic Assessment & Monitoring Asthma Control 43 Key Points – Asthma Control (Goals of Therapy) Reducing impairment – Prevent chronic & troublesome symptoms. – Prevent frequent use (< 2 days /wk) of inhaled SABA for symptoms. – Maintain (near) “normal” pulmonary function. – Maintain normal activity levels (including exercise & other physical activity & attendance at work or school). – Meet patients’ and families’ expectations of and satisfaction with asthma care. EPR- 3, p. 50 44 Key Points – Cont. Reducing Risk – Prevent recurrent exacerbations of asthma and minimize the need for ER visits and hospitalizations. – Prevent progressive loss of lung function - for children, prevent reduced lung growth. – Provide optimal pharmacotherapy with minimal or no adverse effects. Periodic assessments at 1-6 month intervals. Patient self-assessment (w/clinician). Spirometry testing. NAEPP 2007 guidelines, sec. 3, p. 53 45 Key Points Cont. - Written AAP’s & PFM Provide to all patients a written AAP based on signs and symptoms and/or PEF. – Written AAPs are particularly recommended for patients who have moderate or severe persistent asthma, a history of severe exacerbations or poorly controlled asthma”. “Whether PF monitoring, symptoms monitoring (available data show similar benefits for each), or a combo of approaches is used, self- monitoring is important to the effective self-management of asthma” . EPR -3 Sec. 3, P.5346 Peak Flow Monitoring Long-term daily PF monitoring can be helpful to: Detect early changes in asthma control that require adjustments in treatment: – Evaluate responses to changes in treatment – Provide a quantitative measure of impairment NAEPP 2007 guidelines Sec. 3, P.54 47 Key Differences – Assessing/ Monitoring Control Periodic assessment of asthma control is emphasized. A stronger distinction between classifying asthma severity and assessing asthma control. EPR-3 clarifies the issue: – For initiating treatment, asthma severity should be classified, and the initial treatment should correspond to the appropriate severity category. – Once treatment is established, the emphasis is on assessing asthma control to determine if the goals for therapy have been met and if adjustments in therapy (step up or step down) would be appropriate. EPR-3, Sec.3 Pg.54 48 Key Differences Cont. Assessment of asthma control includes the two domains of impairment and risk. Peak flow monitoring: – Assessing diurnal variation was deleted. – Patients are most likely to benefit from routine peak flow monitoring. – Evidence suggests equal benefits to either peak flow or symptom-based monitoring; the important issue continues to be having a monitoring plan in place. Parameters for lung function, specifically FEV1/FVC, were added as measures of asthma control for children. 49 Asthma Control = Asthma Goals Definition of asthma control is the same as asthma goals (slides #44 & 45) reducing impairment and risk. Monitoring quality of life, any: – – – – work or school missed because of asthma? reduction in usual activities? disturbances in sleep due to asthma? Change in caregivers activities due to a child's asthma? There are quality of life assessment tools listed (p.62) 50 Responsiveness Questions for Assessing Asthma Control Ask the patient: Has your asthma awakened you at night or early morning? Have you needed more quick-relief medication (SABA) than usual? Have you needed any urgent medical care for your asthma, such as unscheduled visits to your provider, an UC clinic, or the ER? Are you participating in your usual and desired activities? If you are measuring your peak flow, has it been below your personal best? 51 Adapted from Global Initiative for Asthma: Pocket Guide for Asthma Management & Prevention.” 1995 Responsiveness - Actions Actions to consider: Assess whether the medications are being taken as prescribed. Assess whether the medications are being inhaled with correct technique. Assess lung function with spirometry and compare to previous measurement. Adjust medications, as needed; either step up if control is inadequate or step down if control is maximized, to achieve the best control with the lowest dose of medication. Adapted from Global Initiative for Asthma: Pocket Guide for Asthma Management & Prevention.” 1995 52 Figure 3–5a. Assessing Asthma Control In Children 0 - 4 Years of Age Components of Control Impairment Classification of Asthma Control (Children 04 years of age) Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week >2 days/week Throughout the day Nighttime awakenings 1x/month >1x/month >1x/week Interference with normal activity None Some limitation Extremely limited Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week Several times per day Exacerbations requiring oral systemic corticosteroids 01/year 23/year >3/year Risk Treatment-related adverse effects Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. Figure 3–5b. Assessing Asthma Control In Children 5 - 11 Years of Age Classification of Asthma Control (Children 511 years of age) Components of Control Impairment Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week but not more than once on each day >2 days/week or multiple times on 2 days/week Throughout the day Nighttime awakenings 1x/month 2x/month 2x/week Interference with normal activity None Some limitation Extremely limited Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week Several times per day Lung function FEV1 or peak flow >80% predicted/ personal best 6080% predicted/ personal best <60% predicted/ personal best FEV1/FVC >80% 7580% <75% Exacerbations requiring oral systemic corticosteroids Risk Reduction in lung growth Treatment-related adverse effects 01/year 2/year (see note) Consider severity and interval since last exacerbation Evaluation requires long-term followup. Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. Figure 3–5c. Assessing Asthma Control In Youths 12 Years of Age & Adults Components of Control Symptoms Nighttime awakening Interference with normal activity Impairment Short-acting beta2-agonist use for symptom control (not prevention of EIB) FEV1 or peak flow Classification of Asthma Control (Youths 12 years of age and adults) Well-Controlled Not Well-Controlled Very Poorly Controlled 2 days/week >2 days/week Throughout the day 2x/month 13x/week 4x/week None Some limitation Extremely limited 2 days/week >2 days/week Several times per day >80% predicted/ personal best 6080% predicted/ personal best <60% predicted/ personal best 0 0.75* 20 1–2 1.5 1619 3–4 N/A 15 Validated Questionnaires ATAQ ACQ ACT Exacerbations Risk 01/year 2/year (see note) Consider severity and interval since last exacerbation Progressive loss of lung function Evaluation requires long-term followup care Treatment-related adverse effects Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. Component 2 Education For A Partnership In Asthma Care 56 Key Points - Education Self management education is essential and should be integrated into all aspects of care & requires repetition and reinforcement. Provide all patients with a written asthma action plan that includes 2 aspects: – Daily management – How to recognize & handle worsening asthma symptoms Regular review of the status of patients asthma control. – Teach & reinforce at every opportunity Develop an active partnership with the patient and family. EPR – 3, Section 3, Pg. 93 57 Key Points – Education Cont. Encourage adherence by: – – Choosing a tx regimen that achieves outcomes and addresses preferences important to the patient. Review the success of tx plan and make changes as needed. Tailor the plan to needs of each patient. Encourage community based interventions. Asthma education provided by trained health professionals should be reimbursed and considered an integral part of effective asthma care ! (AE-C) 58 Key Differences –- Patient Education Emphasis on the many points of care & sites available to provide education including efficacy of self management education outside the office setting. Greater emphasis on the 2 aspects of written AAP: 1) daily management 2) how to recognize & handle worsening symptoms including adjustment of medication dose. New sections on impact of cultural and ethnic factors & health literacy that affect education. 59 Educational Interventions In The School Setting Implementation of comprehensive, proven school-based asthma education programs should be provided to children who have asthma to learn asthma self-management skills and help provide an “asthma-friendly” learning environment. EPR -3, Sec. 3, Pg. 107 60 Key Educational Messages Significance of diagnosis Inflammation as the underlying cause Controllers vs. quick-relievers How to use medication delivery devices Triggers, including 2nd hand smoke Home monitoring/ self-management How/when to contact the provider Need for continuous, on-going interaction w/the clinician to step up/down therapy Annual influenza vaccine 61 Other Educational Points of Care ER Department & hospital based Pharmacist Community based Home based for caregivers including home based allergen/ environmental assessment Computer based technology Case management for high-risk patients 62 Maintaining The Partnership Promote open communication w/patient & family by addressing at each visit: Ask early in each visit what concerns they have and what they especially want addressed during the visit. Review short – term goals agreed at initial visit. Review written AAP & steps to take – adjust as needed. Encourage parents to take a copy of the AAP to the school or childcare setting or send a copy to the school nurse!! Teach & reinforce key educational messages. Provide simple, brief, written materials that reinforce the actions and skills taught. 63 Component 3 Control Of Environmental Factors & Comorbid Conditions That Affect Asthma 64 65 Key Points – Environmental Factors For patients w/persistent asthma, evaluate the role of allergens. – – – – – – All patients w/ asthma should: Reduce, if possible, exposure to allergens they are sensitized and exposed to. Understand effective allergen avoidance is multifaceted and individual steps alone are ineffective. Avoid exertion outdoors when levels of air pollution are high. Avoid use of nonselective beta-blockers. Avoid sulfite-containing and other foods they are sensitive to. Consider allergen immunotherapy. 66 Key Points – Environmental Cont. Evaluate a patient for other chronic comorbid conditions when asthma cannot be well controlled. Consider inactivated influenza vaccination for patients w/ asthma. Use of humidifiers are not generally recommended. Employed asthmatics should be asked about possible occupational exposures, particularly those who have new-onset disease. (work related asthma) There is insufficient evidence to recommend any specific environmental strategies to prevent the development of asthma. 67 Key Differences –Environmental Reducing exposure to inhalant indoor allergens can improve asthma control, a multifaceted approach is required; single steps to reduce exposure are generally ineffective. Formaldehyde and volatile organic compounds (VOCs) are potential risk factors for asthma. Influenza vaccine does not appear to reduce the frequency or severity of asthma exacerbations during the influenza season. Discussion is included on ABPA, obesity, OSA, and stress as chronic comorbid conditions, in addition to rhinitis, sinusitis, and gastroesophageal reflux, that may interfere with asthma management. 68 Component 4 Medications 69 Key Points - Medications 2 general classes: – – Long-term control medications Quick-Relief medications Controller medications: – Corticosteroids – Long Acting Beta Agonists (LABA’s) – Leukotriene modifiers (LTRA) – Cromolyn & Nedocromil – Methylxanthines: (Sustained-release theophylline) 70 Key Points – Medications Cont. Quick- relief medications – Short acting bronchodilators (SABA’s) – Systemic corticosteroids – Anticholinergics 71 Key Differences - Medications The most effective medications for long-term therapy are those shown to have anti-inflammatory effects. New medications—immunomodulators—are available for long-term control of asthma. New data on the safety of LABAs are discussed, and the position of LABA in therapy has been revised. The estimated clinical comparability of different ICS preparations is updated. The significant role of ICSs in asthma therapy continues to be supported. 72 EPR-3, pg. 215 Key Points: Safety of ICS’s ICS’s are the most effective long-term therapy available, are well tolerated & safe at recommended doses. The potential but small risk of adverse events from the use of ICS treatment is well balanced by their efficacy. The dose-response curve for ICS treatment begins to flatten at low to medium doses. Most benefit is achieved with relatively low doses, whereas the risk of adverse effects increases with dose. 73 Key Points: Reducing Potential Adverse Effects Spacers or valved holding chambers (VHCs) used with nonbreath-activated MDIs reduce local side effects. – But there is no data on use of spacers with ultra fine particle hydrofluoroalkane (HFA) MDIs. Advise patients to rinse their mouths (rinse and spit) after (ICS) inhalation. Use the lowest dose of ICS that maintains asthma control: – Evaluate patient adherence and inhaler technique as well as environmental factors that may contribute to asthma severity before increasing the dose of ICS. To achieve or maintain control of asthma, add a LABA to a low or medium dose of ICS rather than using a higher dose of ICS. Monitor linear growth in children. 74 Key Points: Safety of Long-Acting Beta2-Agonists (LABA’s) Adding a LABA to the tx of patients whose asthma is not well controlled on low- or medium-dose ICS improves lung function, decreases symptoms, and reduces exacerbations and use of SABA for quick relief in most patients. The FDA determined that a Black Box warning was warranted on all preparations containing a LABA. For patients who have asthma not sufficiently controlled with ICS alone, the option to increase the ICS dose should be given equal weight to the option of the addition of a LABA to ICS. It is not currently recommended that LABA be used for treatment of acute symptoms or exacerbations. LABAs are not to be used as monotherapy for long-term control. 75 Key Points: Safety of SABA’s SABAs are the most effective medication for relieving acute bronchospasm Increasing use of SABA treatment or using SABA >2 days a week for symptom relief (not prevention of EIB) indicates inadequate control of asthma. Regularly scheduled, daily, chronic use of SABA is not recommended. 76 Section 4 Managing Asthma Long Term “The Stepwise Approach” 2007 NAEPP Guidelines, EPR-3, pg. 277 77 Key Differences Managing Asthma Long Term 1. Recommendations for managing asthma in children 0–4 and 5–11 years of age are presented separately from youths ≥12 years of age and adults. 2. Treatment decisions for initiating long-term control therapy are based on classifying severity (considering both impairment and risk domains) and selecting a corresponding step for treatment. – 3. Recommendations on when to initiate therapy in children 0–4 years of age have been revised. Treatment decisions for adjusting therapy and maintaining control are based on assessing the level of asthma control. EPR -3, Pg. 279 78 Key Differences – Cont. 4. Stepwise approach to managing asthma is expanded to include six steps of care. Previous guidelines had several progressive actions within step 3 - updated guidelines separate the actions into different steps. 5. Treatment options within the steps have been revised: – For patients not well controlled on low-dose ICS’s, increasing the dose of ICSs to medium dose is recommended before adding adjunctive therapy in the 0–4 years age group. – For children 5–11 years and youths 12 years 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. 79 Key Differences – Cont. – – – 6. Evidence for the selection of adjunctive therapy is limited in children under 12 years. 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 expanded to include racial and ethnic disparities. 80 Treatment: Principles of “Stepwise” Therapy 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. EPR -3, Section 4, Managing Asthma Long Term in Children 0–4 Years of Age and 5–11 Years of Age, P. 284 81 Principles Of Step Therapy To Maintain Control Step up if not controlled. If very poorly controlled, consider increase by 2 steps, oral corticosteroids, or both. Before increasing pharmacologic therapy, consider as targets for therapy. – Adverse environmental exposures – Poor adherence – Co-morbidities 82 Follow-Up Visits every 2-6 weeks until control achieved. When control achieved, contact every 3-6 months. Step-down in therapy: – With well-controlled asthma for at least 3 months. – Patients may relapse with total discontinuation or reduction of inhaled corticosteroids. 83 Assessing Control & Adjusting Therapy Children 0-4 Years of Age Classification of Asthma Control (04 years of age) Components of Control Impairment Risk Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week >2 days/week Throughout the day Nighttime awakenings 1x/month >1x/month >1x/week Interference with normal activity None Some limitation Extremely limited Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week Several times per day Exacerbations requiring oral systemic corticosteroids 01/year 23/year >3/year Treatment-related adverse effects Recommended Action for Treatment (See figure 41a for treatment steps.) Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. • Maintain current treatment. • Regular followup every 16 months. • Consider step down if well controlled for at least 3 months. • Step up (1 step) and • Reevaluate in 26 weeks. • If no clear benefit in 46 weeks, consider alternative diagnoses or adjusting therapy. • For side effects, consider alternative treatment options. • Consider short course of oral systemic corticosteroids, • Step up (12 steps), and • Reevaluate in 2 weeks. • If no clear benefit in 46 weeks, consider alternative diagnoses or adjusting therapy. • For side effects, consider alternative treatment options. Stepwise Approach for Managing Asthma in Children 0-4 Years of Age Intermittent Asthma Persistent Asthma: Daily Medication Consult asthma specialist if step 3 care or higher is required. Consider consultation at step 2 Step 6 Step up if needed Preferred (first check adherence, environment al control) Step 5 Step 4 Step 2 Preferred Step 1 Preferred SABA PRN Low dose ICS Alternative Montelukast or Cromolyn Step 3 Preferred Preferred Medium Dose ICS Medium Dose ICS AND Preferred High Dose ICS AND Either: Montelukast Either: High Dose ICS AND Either: Montelukast or LABA or LABA Montelukast or LABA AND Oral corticosteroid Patient Education and Environmental Control at Each Step Quick-relief medication for ALL patients -SABA as needed for symptoms. With VURI: SABA every 4-6 hours up to 24 hours. Consider short course of corticosteroids with (or hx of) severe exacerbation Assess control Step down if possible (and asthma is well controlled at least 3 months) Assessing Control & Adjusting Therapy Children 5-11 Years of Age Classification of Asthma Control (511 years of age) Components of Control Impairment Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week but not more than once on each day >2 days/week or multiple times on 2 days/week Throughout the day Nighttime awakenings 1x/month 2x/month 2x/week Interference with normal activity None Some limitation Extremely limited Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week Several times per day Lung function • FEV1 or peak flow >80% predicted/ personal best 6080% predicted/ personal best <60% predicted/ personal best • FEV1/FVC >80% 7580% <75% Exacerbations requiring oral systemic corticosteroids Risk Reduction in lung growth Treatment-related adverse effects Recommended Action for Treatment (See figure 41b for treatment steps.) 2/year (see note) 01/year Consider severity and interval since last exacerbation Evaluation requires long-term followup. Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. • Maintain current step. • Regular followup every 16 months. • Consider step down if well controlled for at least 3 months. • Step up at least 1 step and • Reevaluate in 26 weeks. • For side effects: consider alternative treatment options. • Consider short course of oral systemic corticosteroids, • Step up 12 steps, and • Reevaluate in 2 weeks. • For side effects, consider alternative treatment options. Stepwise approach for managing asthma in children 5-11 years of age Intermittent Asthma Persistent Asthma: Daily Medication Consult asthma specialist if step 4 care or higher is required. Consider consultation at step 3 Step 5 Step 2 Preferred Step 1 Low dose ICS Preferred Alternative SABA PRN LTRA, Cromolyn Nedocromil or Theophylline Step 4 Preferred Step 3 Preferred Preferred Medium Dose ICS + LABA High Dose ICS + LABA Either Low Dose ICS + LABA, LTRA, or Theophylline OR Medium Dose ICS Alternative Medium dose ICS + either LTRA, or Theophylline Step 6 Preferred High Dose ICS + LABA + oral corticosteroid Alternative Alternative High dose ICS + either LTRA, or Theophylline High dose ICS + either LTRA, or Theophylline + oral corticosteroid Patient Education and Environmental Control at Each Step Quick-relief medication for ALL patients SABA as needed for symptoms. Short course of oral corticosteroids maybe needed. Step up if needed (first check adherence, environmen tal control, and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) Assessing Control & Adjusting Therapy In Youths > 12 Years of Age & Adults Classification of Asthma Control (12 years of age) Components of Control Well Controlled Impairment Not Well Controlled Very Poorly Controlled Symptoms 2 days/week >2 days/week Throughout the day Nighttime awakenings 2x/month 13x/week 4x/week Interference with normal activity None Some limitation Extremely limited Short-acting beta2-agonist use for symptom control (not prevention of EIB) 2 days/week >2 days/week Several times per day FEV1 or peak flow >80% predicted/ personal best 6080% predicted/ personal best <60% predicted/ personal best 0 0.75* 20 1–2 1.5 1619 3–4 N/A 15 Validated questionnaires ATAQ ACQ ACT Exacerbations requiring oral systemic corticosteroids Risk 2/year (see note) 01/year Consider severity and interval since last exacerbation Progressive loss of lung function Evaluation requires long-term followup care Treatment-related adverse effects Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control but should be considered in the overall assessment of risk. Recommended Action for Treatment (see figure 45 for treatment steps) • Maintain current step. • Regular followups every 16 months to maintain control. • Consider step down if well controlled for at least 3 months. • Step up 1 step and • Reevaluate in 26 weeks. • For side effects, consider alternative treatment options. • Consider short course of oral systemic corticosteroids, • Step up 12 steps, and • Reevaluate in 2 weeks. • For side effects, consider alternative treatment options. Stepwise Approach for Managing Asthma in Youths >12 Years of Age & Adults Intermittent Asthma Persistent Asthma: Daily Medication Consult asthma specialist if step 4 care or higher is required. Consider consultation at step 3 Step 6 Step 5 Step 4 Step 3 Preferred: Low dose ICS Low-dose ICS + LABA OR – Medium dose ICS Alternative: Cromolyn, LTRA, Nedocromil or Theophylline Alternative: Low-dose ICS + either LTRA, Theophylline, or Zileuton Step 2 Preferred: Step 1 Preferred: SABA PRN Preferred: Medium Dose ICS + LABA Alternative: Medium-dose ICS + either LTRA, Theophylline, or Zileuton Preferred High Dose ICS + LABA AND Consider Omalizumab for patients who have allergies Preferred High dose ICS + LABA + oral corticosteroid AND Consider Omalizumab for patients who have allergies Each Step: Patient Education and Environmental Control and management of comorbidities Steps 2 – 4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma Step up if needed (first check adherence, environmental control & comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) •Quick-relief medication for ALL patients -SABA as needed for symptoms: up to 3 tx @ 20 minute intervals prn. Short course of o systemic corticosteroids may be needed. • Use of SABA >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control & the need to step up treatment. Section 5 Managing Exacerbations of Asthma 2007 Asthma Guidelines, EPR – 3, Pg. 373 90 Key Points – Managing Exacerbations Early treatment of asthma exacerbations is the best strategy for management. Patient education includes a written asthma action plan to guide patient self-management of exacerbations. – especially for patients who have moderate or severe persistent asthma and any patient who has a history of severe exacerbations. A peak-flow-based plan for patients who have difficulty perceiving airflow obstruction and worsening asthma. EPR -3 Pg. 373 91 Key Points – Cont. Recognition of early signs of worsening asthma & taking prompt action. Appropriate intensification of therapy, often including a short course of oral corticosteroids. Removal of the environmental factors contributing to the exacerbation. Prompt communication between patient and clinician about any serious deterioration in symptoms or peak flow, decreased responsiveness to SABAs, or decreased duration of effect. 92 Key Differences From 1997 & 2002 Expert Panel Reports For the treatment of exacerbations, the current update: Simplifies classification of severity of asthma exacerbations. Adds levalbuterol as a SABA treatment for asthma exacerbations. For home management of exacerbations, no longer recommends doubling the dose of ICSs. For prehospital management (e.g., emergency transport), encourages standing orders for albuterol and—for prolonged transport—repeated treatments and protocols to allow consideration of ipratropium and oral corticosteroids. For ED management, reduces dose and frequency of oral corticosteroids in severe exacerbations, adds consideration of magnesium sulfate or heliox for severe exacerbations, and adds consideration of initiating an ICS upon discharge. 93 Exacerbations Defined (Risk) Are acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness — or some combination of these symptoms. Are characterized by decreases in expiratory airflow that can be documented and quantified by spirometry or Peak expiratory flow. – These objective measures more reliably indicate the severity of an exacerbation than does the severity of symptoms. 94 Classifying Severity of Asthma Exacerbations in the UC or ER Setting Severity Mild Moderate Severe Symptoms & Signs Dyspnea only with activity (assess tachypnea in young children) Dyspnea interferes with or limits usual activity Dyspnea at rest; interferes with conversation Initial PEF (or FEV1) Clinical Course PEF 70 percent predicted or personal best Usually cared for at home Prompt relief with inhaled SABA Possible short course of oral systemic corticosteroids PEF 4069 percent predicted or personal best Usually requires office or ED visit Relief from freq. inhaled SABA Oral systemic corticosteroids; some symptoms last 1–2 days after treatment is begun PEF <40 percent predicted or personal best Usually requires ED visit and likely hospitalization Partial relief from frequent inhaled SABA PO systemic corticosteroids; some symptoms last >3 days after treatment is begun Adjunctive therapies are helpful Subset: Life threatening Too dyspneic to speak; perspiring PEF <25 percent predicted or personal best Requires ED/hospitalization; possible ICU Minimal or no relief w/ frequent inhaled SABA Intravenous corticosteroids Adjunctive therapies are helpful Managing Asthma Exacerbations At Home Assess Severity Patients at high risk for a fatal attack (see figure 5–2a) require immediate medical attention after initial treatment. Symptoms and signs suggestive of a more serious exacerbation such as marked breathlessness, inability to speak more than short phrases, use of accessory muscles, or drowsiness (see figure 5–3) should result in initial treatment while immediately consulting with a clinician. Less severe signs and symptoms can be treated initially with assessment of response to therapy and further steps as listed below. If available, measure PEF—values of 50–79% predicted or personal best indicate the need for quick-relief mediation. Depending on the response to treatment, contact with a clinician may also be indicated. Values below 50% indicate the need for immediate medical care. Initial Treatment Inhaled SABA: up to two treatments 20 minutes apart of 2–6 puffs by metered-dose inhaler (MDI) or nebulizer treatments. Note: Medication delivery is highly variable. Children and individuals who have exacerbations of lesser severity may need fewer puffs than suggested above. Good Response Incomplete Response Poor Response No wheezing or dyspnea (assess tachypnea in young children). Persistent wheezing and dyspnea (tachypnea). Marked wheezing and dyspnea. PEF 80% predicted or personal best. Contact clinician for followup instructions and further management. May continue inhaled SABA every 3–4 hours for 24–48 hours. Consider short course of oral systemic corticosteroids. PEF 50–79% predicted or personal best. Add oral systemic corticosteroid. Continue inhaled SABA. Contact clinician urgently (this day) for further instruction. PEF <50% predicted or personal best. Add oral systemic corticosteroid. Repeat inhaled SABA immediately. If distress is severe and nonresponsive to initial treatment: —Call your doctor AND —PROCEED TO ED; —Consider calling 9–1–1 (ambulance transport). To ED. What The EPR -3 Does NOT Recommend Drinking large volumes of liquids or breathing warm, moist air (e.g., the mist from a hot shower). Using over-the-counter products such as antihistamines or cold remedies. Although pursed-lip and other forms of controlled breathing may help to maintain calm during respiratory distress, these methods do not bring about improvement in lung function. EPR -3 , P.384 97 Many Thanks To Colleagues who shared their power point presentations and/or provided feedback on this presentation: Dr. Gail M Brottman MD, Director, Pediatric Pulmonary Medicine, HCMC Dr. Don Uden, Pharm. D., Professor, University of Minnesota, College of Pharmacy Dr. Barbara P. Yawn, MD, MSc, Director of Research, Olmsted Medical Clinic Dr. Mamta Reddy, MD, Chief Allergy/ Immunology, Bronx Lebanon Hospital Center, NY Mary Bielski, RN, LSN, CNS, Nursing Service Manager, Minneapolis Public Schools 98 Minnesota Department of Health Asthma Program www.health.state.mn.us/asthma 99