highlights of the 2007 nih asthma guidelines

1. Highlights of the 2007 NIH Asthma Guidelines Carlos A. Camargo, MD, DrPH Massachusetts General Hospital Harvard Medical School Boston, MA June 19, 2008

2. Assessment & monitoring Education for partnership in asthma care Control of environmental factors and comorbid conditions Pharmacologic therapy Assessment & monitoring Education for partnership in asthma care Control of environmental factors and comorbid conditions Pharmacologic therapy

3. Definitions of Asthma Chronic lung disease characterized by:1 Airway narrowing that is reversible (± completely) either spontaneously or with treatment Airway inflammation Airway hyper-responsiveness to a variety of stimuli.

4. Examples of Asthma Phenotypes Age of onset: childhood vs. adult Time of day: nocturnal Specific activities (eg, exercise-induced) Poor perception of dyspnea Other comorbidities (eg, obesity, GERD) Rx response (eg, steroid-refractory) Atopy status (eg, non-atopic) Eosinophil status (eg, non-eosinophilic)

5. Prevalence of Childhood AsthmaUnited States, 1980-2005 Akinbami LJ. The State of childhood asthma, United States, 1980–2005. Advance data from vital and health statistics; no 381, Hyattsville, MD: National Center for Health Statistics. 2006. EXAMPLE OF QUESTIONS Have you ever been told by a doctor, nurse, or other health professional that you have asthma?” Current asthma was defined as a “yes” response to the same question and the question, “Do you still have asthma?” Akinbami LJ. The State of childhood asthma, United States, 1980–2005. Advance data from vital and health statistics; no 381, Hyattsville, MD: National Center for Health Statistics. 2006. EXAMPLE OF QUESTIONS Have you ever been told by a doctor, nurse, or other health professional that you have asthma?” Current asthma was defined as a “yes” response to the same question and the question, “Do you still have asthma?”

6. ED Visits for Acute Asthma, 1993-2004

9. Methods to Establish Diagnosis Detailed medical history. Physical exam focusing on the upper respiratory tract, chest, and skin. Spirometry to demonstrate obstruction and assess reversibility (eg, age 5+ yrs). Additional studies as necessary to exclude alternate diagnoses. Clinician should determine that: Episodic symptoms of airflow obstruction or airway hyper-responsiveness are present. Airflow obstruction is at least partially reversible. Alternative diagnoses are excluded. Reversibility is determined either by an increase in FEV1 of ?12 percent from baseline or by an increase ?10 percent of predicted FEV1 after inhalation of a short-acting bronchodilator. Clinician should determine that: Episodic symptoms of airflow obstruction or airway hyper-responsiveness are present. Airflow obstruction is at least partially reversible. Alternative diagnoses are excluded. Reversibility is determined either by an increase in FEV1 of ?12 percent from baseline or by an increase ?10 percent of predicted FEV1 after inhalation of a short-acting bronchodilator.

10. Onset of Symptoms inChildren With Asthma Dodge R, Martinez FD, Cline MG, Lebowitz MD, Burrows B. Early childhood respiratory symptoms and the subsequent diagnosis of asthma. J Allergy Clin Immunol 1996;98:48-54. Wainwright C, Isles AF, Francis PW. Asthma in children. Med J Aust 1997;167:218-222. McNicol KN,Williams HB. Spectrum of asthma in children. I. Clinical and physiological components. BMJ 1973;4:7-11. Dodge R, Martinez FD, Cline MG, Lebowitz MD, Burrows B. Early childhood respiratory symptoms and the subsequent diagnosis of asthma. J Allergy Clin Immunol 1996;98:48-54. Wainwright C, Isles AF, Francis PW. Asthma in children. Med J Aust 1997;167:218-222. McNicol KN,Williams HB. Spectrum of asthma in children. I. Clinical and physiological components. BMJ 1973;4:7-11.

11. Natural History of Childhood Wheeze

12. Modified Asthma Predictive Index = persistent asthma (age 0-4) in EPR3 (see severity figure) Modified Asthma Predictive Index (mAPI) The Asthma Predictive Index (API) was originally developed by Castro-Rodriguez et al, based on data from the Tucson Children’s Respiratory Study.14 A stringent index requires frequent wheezing in the first 3 years of life plus 1 of 2 major criteria (parental diagnosis of asthma, diagnosis of eczema in the child) or 2 of 3 minor criteria (diagnosis of allergic rhinitis in the child, eosinophilia [ie, eosinophils ?4% of the total white blood cells], wheezing apart from colds).14 A loose index for the prediction of asthma requires any wheezing during the first 3 years of life plus 1 of 2 major criteria or 2 of 3 minor criteria.14 Children with a positive loose index were up to 5.5 times more likely to have active asthma between 6 and 13 years of age, compared with children with a negative loose index. Children with a positive stringent index were up to 9.8 times more likely.14 The Prevention of Early Asthma in Kids (PEAK) criteria for a modified asthma predictive index (mAPI) were adapted from the Tucson Children’s Respiratory Study’s original tool and are more specific than the original API criteria. The mAPI is shown on this slide. The mAPI criteria specify the frequency of wheezing as >3 exacerbations of wheezing in the past 12 months, with at least 1 physician-confirmed exacerbation.15,16 APPLIED TO CHILDREN AGE 3.0 YEARS Additionally, the mAPI specifies allergic sensitization to ?1 aeroallergen among the major criteria and replaces allergic rhinitis as a minor criterion with allergic sensitization to milk, egg, or peanuts.15,16 The PEAK study has been designed to investigate the role of ICS in preventing persistent asthma in children with a positive mAPI.15,16 14. Castro-Rodríguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med. 2000;162:1403-1406. 15. Guilbert TW, Morgan WJ, Krawiec M, et al. The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma and Research Network. Control Clin Trials. 2004;25:286-310. 16. Guilbert TW, Morgan WJ, Zeiger RS, et al. Atopic characteristics of children with recurrent wheezing at high risk for the development of childhood asthma. J Allergy Clin Immunol. 2004;114:1282-1287. = persistent asthma (age 0-4) in EPR3 (see severity figure) Modified Asthma Predictive Index (mAPI) The Asthma Predictive Index (API) was originally developed by Castro-Rodriguez et al, based on data from the Tucson Children’s Respiratory Study.14 A stringent index requires frequent wheezing in the first 3 years of life plus 1 of 2 major criteria (parental diagnosis of asthma, diagnosis of eczema in the child) or 2 of 3 minor criteria (diagnosis of allergic rhinitis in the child, eosinophilia [ie, eosinophils ?4% of the total white blood cells], wheezing apart from colds).14 A loose index for the prediction of asthma requires any wheezing during the first 3 years of life plus 1 of 2 major criteria or 2 of 3 minor criteria.14 Children with a positive loose index were up to 5.5 times more likely to have active asthma between 6 and 13 years of age, compared with children with a negative loose index. Children with a positive stringent index were up to 9.8 times more likely.14 The Prevention of Early Asthma in Kids (PEAK) criteria for a modified asthma predictive index (mAPI) were adapted from the Tucson Children’s Respiratory Study’s original tool and are more specific than the original API criteria. The mAPI is shown on this slide. The mAPI criteria specify the frequency of wheezing as >3 exacerbations of wheezing in the past 12 months, with at least 1 physician-confirmed exacerbation.15,16 APPLIED TO CHILDREN AGE 3.0 YEARS Additionally, the mAPI specifies allergic sensitization to ?1 aeroallergen among the major criteria and replaces allergic rhinitis as a minor criterion with allergic sensitization to milk, egg, or peanuts.15,16 The PEAK study has been designed to investigate the role of ICS in preventing persistent asthma in children with a positive mAPI.15,16 14. Castro-Rodríguez JA, Holberg CJ, Wright AL, Martinez FD. A clinical index to define risk of asthma in young children with recurrent wheezing. Am J Respir Crit Care Med. 2000;162:1403-1406. 15. Guilbert TW, Morgan WJ, Krawiec M, et al. The Prevention of Early Asthma in Kids study: design, rationale and methods for the Childhood Asthma and Research Network. Control Clin Trials. 2004;25:286-310. 16. Guilbert TW, Morgan WJ, Zeiger RS, et al. Atopic characteristics of children with recurrent wheezing at high risk for the development of childhood asthma. J Allergy Clin Immunol. 2004;114:1282-1287.

13. NIH/NAEPP Asthma Guidelines National Asthma Education and Prevention Program (National Heart, Lung and Blood Institute – NHLBI)

14. 2007 NIH Asthma Guidelines Third Expert Panel Report (EPR-3) Systematic review since 1997 First meeting in 2004 Public comment, Feb 2007 Final posted Aug + Oct 2007 http://www.nhlbi.nih.gov/guidelines/asthma Resource document = 440 pages Summary report = 74 pagesResource document = 440 pages Summary report = 74 pages

15. Major Changes in 2007 Guidelines Assessment and monitoring Severity Control Responsiveness to treatment Three age groups: 0-4, 5-11, 12+ years Expanded steps (6)

16. Key Definitions Severity = the intrinsic intensity of the disease process, measured clinically in untreated patients or by the least amount of medication required to achieve control Control = the degree to which the manifestations of asthma (e.g., symptoms, functional impairment, risk of untoward events) are minimized and the goals of therapy are met Responsiveness = the ease with which control is achieved by therapy

17. Key Definitions (continued) Severity & control defined using 2 domains: Impairment = frequency and intensity of symptoms and functional limitations (e.g., symptoms, albuterol use, activities, QOL, lung function) Risk = likelihood of exacerbation, progressive decline in lung function, adverse effects from medications

18. Goal of Therapy = Control Reduce impairment – e.g., prevent symptoms, infrequent SABA use, normal activities, (near) normal lung function, patient satisfaction Reduce risk – e.g., prevent recurrent exacerbations, decrease healthcare utilization, prevent lung function decline, optimal Rx with little (if any) adverse effects

19. Highlights of 2007 Guidelines Severity ? initiating therapy Control ? monitoring & adjusting therapy Three key figures for age 12+ Severity Stepwise approach to initiating therapy Control … Recommended action

20. Severity, age ?12 yearsSeverity, age ?12 years

21. Non-pharmaceutical Approaches Patient education Environmental control Home Workplace Management of comorbidities Allergies GERD Obesity Importance of multi-faceted approaches for environmental control Importance of multi-faceted approaches for environmental control

22. Stepwise Approach, age ?12 y Stepwise Approach, age ?12 y

23. Asthma Control Test (ACT)

24. Recommended Action A larger version of this slide is available in the back of the slide booklet. Recommended Action A larger version of this slide is available in the back of the slide booklet.

25. Selected Reasons Why Asthma “Not Well-Controlled” Wrong diagnosis Poor adherence to recommended treatment Underestimation of asthma severity Environmental factors Co-morbidities, such as Obesity Gastroesophageal reflux

26. Follow-up Visits every 2-6 weeks until control achieved Are goals being met? Are adjustments necessary? Before increasing pharmacologic therapy, consider environment, adherence, and comorbidities Step up if not controlled If very poorly controlled, consider increase by 2 steps, oral corticosteroids, or both When control achieved, contact every 3-6 months

27. Step-down in Therapy Consider if well-controlled asthma for at least 3 months Decrease inhaled corticosteroids by 25-50% every 3 months to lowest effective dose Note: Patients may relapse with total discontinuation of inhaled corticosteroids

28. Referral to a Specialist If difficulty achieving or maintaining control If step 4 or higher care required If immunotherapy (steps 2-4) or omalizumab (steps 5-6) are considered If asthma hospitalization (?) Consider referral for step 3 care

29. Asthma Exacerbations 1991 cut points for acute asthma severity: <40%, 40-69%, ?70% predicted FEV1 or PEF Home: do not double the dose of ICS Prehospital: standing order for albuterol and importance of protocols ED: consider adjunct therapies in severe exacerbations; consider initiating ICS at discharge Hospital: anticholinergics not recommended

30. Summary Asthma epidemiology Modified API 2007 NIH asthma guidelines: Severity vs. control Impairment and risk Goal = control (per clinical & patient self-assessment) Asthma exacerbations

31. Questions?

32. Severity, age ?12 yearsSeverity, age ?12 years

33. Stepwise Approach, age ?12 yStepwise Approach, age ?12 y

34. Recommended ActionRecommended Action

35. Severity, age 5-11 yearsSeverity, age 5-11 years

36. Stepwise Approach, age 5-11 yStepwise Approach, age 5-11 y

37. Recommended ActionRecommended Action

38. Severity, age 0-4 yearsSeverity, age 0-4 years

39. Stepwise Approach, age 0-4 yStepwise Approach, age 0-4 y

40. Recommended ActionRecommended Action