1. Overview of Changes to the NAEP Asthma Guidelines Breathe California’s Clinical Asthma Collaborative Susan M. Pollart, MD, MS University of Virginia Family Medicine June 24, 2009

2. Overview  Asthma classification by Severity and Control  Level of Severity and of Control relate to current impairment and future risk.  ICS Mainstay of treatment  Low dose ICS plus LABA equal to Medium dose LABA in adults and children >5  Written action plans important.

3. New Classification  “Classification” is based on SEVERITY at time of DIAGNOSIS.  Patient is not taking long-term controller medication  Based on two parameters – impairment and risk  Can also be determined once asthma control is achieved.

4. Assess Control to Adjust Therapy  Once therapy is initiated, the emphasis is on control.  Control determined by two parameters – impairment and risk.  Level of control guides decisions about adjusting therapy.  Step-up and Step-down still apply

5. Components of Severity Classification of Asthma Severity (≥12 years of age) Intermittent Persistent MildModerateSevere Impairment Normal FEV 1 /FVC: 8-19 yr 85% 20-39 yr 80% 40-59 yr 75% 60-80 yr 70% Symptoms≤ 2 days/week>2 days/week but not daily DailyThroughout the day Nighttime awakenings ≤ 2x/month3-4x/month>1x/week but not nightly Often 7x/week Short-acting beta 2 - agonist use for symptom control (not prevention of EIB) ≤ 2 days/week>2 days/week but not daily, and not more than 1x on any day DailySeveral times per day Interference with normal activity NoneMinor limitationSome limitationExtremely limited Lung function  Normal FEV 1 between exacerbations  FEV 1 > 80% predicted  FEV 1 /FVC normal  FEV 1 >80% predicted  FEV 1 /FVC normal  FEV 1 >60% but <80% predicted  FEV 1 /FVC reduced 5%  FEV 1 < 60% predicted  FEV 1 /FVC reduced >5% Risk Exacerbations requiring oral systemic corticosteroids 0-1/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 FEV 1 Recommended Step for Initiating Treatment Step 1Step 2 Step 3 Step 4 or 5 and consider short course of oral systemic corticosteroids In 2-6 weeks, evaluate level of asthma control that is achieved and adjust therapy accordingly CLASSIFYING ASTHMA SEVERITY AND INITIATING TREATMENT IN YOUTHS ≥ 12 YEARS OF AGE AND ADULTS Assessing severity and initiating treatment for patients who are not currently taking long-term control medications Key: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICU, intensive care unit Note: At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. In general, more frequent and intense exacerbations (e.g. requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity. For treatment purposes, patients who had ≥ 2 exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma.

6. Stepwise Approach for Managing Asthma in Youths ≥ 12 Years of Age and Adults Step 1 Preferred: SABA PRN Intermittent Asthma Step2 Preferred: Low-dose ICS Alternative: Cromolyn, LTRA, Nedocromil, or Theophylline Step 4 Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS+either LTRA, Theophylline, or Zileuton Step 5 Preferred: High-dose ICS + LABA AND Consider Omalizumab for patients who have allergies Step 6 Preferred: High-dose ICS + LABA + oral corticosteroid AND Consider Omalizumab for patients who have allergies Step up if needed (first, check adherence, environmental control, and comorbid conditions) Step down if possible (and asthma is well controlled at least 3 months) Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. EIB, exercise-induced bronchospasm; ICS, inhaled corticosteroid; LABA, inhaled long-acting beta 2 -agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta 2 -agonist Each step: Patient education, environmental control, and management of comorbidities. Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma * Step 3 Preferred: Low dose ICS + LABA OR medium- dose ICS Alternative: low-dose ICS + either LTRA, Theophylline, or Zileuton Quick-Relief Medication for All Patients SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral systemic corticosteroids may be needed Caution: Increasing use of SABA or use >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment. * Immunotherapy for steps 2-4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults. Clinicians who administer immunotherapy should be prepared and equipped to identify and treat anaphylaxis that may occur. Assess control

7. ASSESSING ASTHMA CONTROL AND ADJUSTING THERAPY IN YOUTH ≥ 12 YEARS OF AGE AND ADULTS Components of Control Classification of Asthma Control ( ≥ 12 years of age) Well Controlled Not Well Controlled Very Poorly Controlled Impairment Symptoms ≤ 2 days/week>2 days/weekThroughout the day Nighttime awakenings≤ 2x/month1-3x/week≥ 4x/week Interference with normal activity NoneSome limitationExtremely limited Short-acting beta 2 -agonist use for symptom control (not prevention of EIB) ≤ 2 days/week>2 days/weekSeveral times per day FEV 1 or peak flow>80% predicted/ personal best 60-80% predicted/ personal best <60% predicted/ personal best Validated Questionnaires ATAQ ACQ ACT 0 ≤ 0.75* ≥ 20 1-2 ≥ 1.5 16-19 3-4 N/A ≤ 15 Risk Exacerbations requiring oral systemic corticosteroids 0-1/year ≥ 2/year (see note) Progressive loss of lung function Evaluation requires long-term follow-up 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  Maintain current step.  Regular follow ups every 1-6 months to maintain control.  Consider step down if well controlled for at least 3 months.  Step up 1 step and  Reevaluate in 2- 6 weeks.  For side effects, consider alternative treatment options.  Consider short course of oral systemic corticosteroids,  Step up 1-2 steps, and  Reevaluate in 2 weeks.  For side effects, consider alternative treatment options. *ACQ values of 0.76-1.4 are indeterminate regarding well-controlled asthma. Key: EIB, exercise-induced bronchospasm; ICU, intensive care unit. Consider severity and interval since last exacerbation Note: At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. In general, more frequent and intense exacerbations (e.g. requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity. For treatment purposes, patients who had ≥ 2 exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma.

8. Asthma Control Test Copyright 2002, by QualityMetric Incorporated. Asthma Control Test is a trademark of QualityMetric Incorporated.

9. Stepwise Approach for Managing Asthma in Youths ≥ 12 Years of Age and Adults Step 1 Preferred: SABA PRN Intermittent Asthma Step2 Preferred: Low-dose ICS Alternative: Cromolyn, LTRA, Nedocromil, or Theophylline Step 4 Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS+either LTRA, Theophylline, or Zileuton Step 5 Preferred: High-dose ICS + LABA AND Consider Omalizumab for patients who have allergies Step 6 Preferred: High-dose ICS + LABA + oral corticosteroid AND Consider Omalizumab for patients who have allergies Step up if needed (first, check adherence, environmental control, and comorbid conditions) Step down if possible (and asthma is well controlled at least 3 months) Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Key: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. EIB, exercise-induced bronchospasm; ICS, inhaled corticosteroid; LABA, inhaled long-acting beta 2 -agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta 2 -agonist Each step: Patient education, environmental control, and management of comorbidities. Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma * Step 3 Preferred: Low dose ICS + LABA OR medium- dose ICS Alternative: low-dose ICS + either LTRA, Theophylline, or Zileuton Quick-Relief Medication for All Patients SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral systemic corticosteroids may be needed Caution: Increasing use of SABA or use >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment. * Immunotherapy for steps 2-4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults. Clinicians who administer immunotherapy should be prepared and equipped to identify and treat anaphylaxis that may occur. Assess control

10. Preferred Medications  STEP 1 – SABA  STEP 2 – ICS  STEP 3 – ICS plus LABA or med dose ICS  STEP 4 – med dose ICS plus LABA  STEP 5 – high dose ICS and LABA  STEP 6 – high dose ICA and LABA and oral corticosteroids.

11. Alternative Medications  Mast cell inhibitors  Leukotriene receptor antagonists  Leukotriene modifier  Theophylline  Omalizumab

12. Inhaled medication  Short-acting beta-agonists – albuterol mentioned as “preferred” in pregnancy  Long-acting beta-agonists – used w/ low dose ICS (vs medium dose ICS) as step up in all but 0-4 age group. Alternative at step 4 and above in all.

13. Inhaled medication  Inhaled corticosteroids (ICS) the preferred long term controller in all age groups.  Low dose ICS alone in step 2 for all.  Low dose plus add-on OR medium dose ICS for step 3 except ages 0-4.

14. Leukotriene modifiers  Montelukast safe for all patients,of all ages, as alternative to low dose ICS or add on to low, medium or high dose ICS.  Zafirlukast same role in all but 0-4 age group.  Zileuton in age > 12 as add on to low dose ICS + LABA, or to medium dose ICS

15. Cromolyn and Nedocromil  Stabilize mast cells and interfere with chloride channels  Can be used as an alternative but not preferred medication in step 2 in all.  Preventive therapy for exercise/exposure

16. Theophylline  Mild to moderate bronchodilator  May have mild anti-inflammatory effect.  Alternative or adjunctive therapy with ICS in all patients > 5  Monitoring levels essential.

17. Written Action Plan  Written action plans detailing medications and environmental control strategies tailored for each patient are recommended for all patients with asthma  Environmental Control  Awareness and control

18. Asthma Action Plan Examples

19. Written Action Plan Components  Note when and how to treat signs of an exacerbation  Adjust meds by increasing SABA, add oral CS.  To be effective, patient must have prescription for oral CS available  Doubling dose of ICS not part of plan – not effective during exacerbation.

20. Peak Expiratory Flow  PEF based plan particularly useful for those who have difficulty perceiving airflow obstruction or have history of severe exacerbations  “Gold standard” is patient’s personal best.  Green/yellow/red zones objective data.

21. Environmental Control  House dust mite – mattress covers, pillow covers, washing in hot water, acaricides  Cat Allergen – air filters, washing the cat, keep cat out of the bedroom.  Cockroach – extermination and thorough cleaning No evidence that any of these change patient oriented outcomes.

22. Summary  Asthma classification by Severity and Control  Level of Severity and of Control relate to current impairment and future risk.  ICS Mainstay of treatment  Low dose ICS plus LABA equal to Medium dose LABA in adults and children >5  Written action plans important.