1. G IN A lobal itiative for sthma lobal itiative for sthma

2. Program Objectives  Increase appreciation of asthma as a global public health problem  Present key recommendations for diagnosis and management of asthma  Provide strategies to adapt recommendations to varying health needs, services, and resources  Identify areas for future investigation of particular significance to the global community  Increase appreciation of asthma as a global public health problem  Present key recommendations for diagnosis and management of asthma  Provide strategies to adapt recommendations to varying health needs, services, and resources  Identify areas for future investigation of particular significance to the global community

3. Executive Committee Chair: Tim Clark, MD Dissemination Committee Chair: Martyn Partridge, MD GINA Structure ScienceCommittee Chair: Paul O’Byrne, MD GINA reports prepared during workshops conducted in cooperation with the U.S. National Heart, Lung, and Blood Institute, NIH and the World Health Organization.

4. GINA Sponsors AstraZeneca Merck, Sharp & Dohme Aventis Mitsubishi Pharma Bayer Nikken Chemicals Boehringer Ingelheim Novartis Byk GuldenSchering-Plough Chiesi Sepracor GlaxoSmithKline Viatris Yamanouchi AstraZeneca Merck, Sharp & Dohme Aventis Mitsubishi Pharma Bayer Nikken Chemicals Boehringer Ingelheim Novartis Byk GuldenSchering-Plough Chiesi Sepracor GlaxoSmithKline Viatris Yamanouchi

5. Executive Committee T. Clark, UK, Chair K. Ohta, Japan J. Bousquet, France M. Partridge, UK W. Busse, USA S. Pedersen, Denmark S. Holgate, UK R. Singh, India C. Lenfant, USA A. Sheffer, USA P. O’Byrne, Canada W. Tan, Singapore T. Clark, UK, Chair K. Ohta, Japan J. Bousquet, France M. Partridge, UK W. Busse, USA S. Pedersen, Denmark S. Holgate, UK R. Singh, India C. Lenfant, USA A. Sheffer, USA P. O’Byrne, Canada W. Tan, Singapore

6. Science Committee P. O’Byrne, Canada, Chair P. Barnes, UK P. Gibson, Australia E. Bateman, S. Africa S. Holgate, UK J. Bousquet, France J. Kips, Belgium W. Busse, USA K. Ohta, Japan J. Drazen, USA S. Pedersen, Denmark M. FitzGerald, Canada E. von Mutius, Germany P. O’Byrne, Canada, Chair P. Barnes, UK P. Gibson, Australia E. Bateman, S. Africa S. Holgate, UK J. Bousquet, France J. Kips, Belgium W. Busse, USA K. Ohta, Japan J. Drazen, USA S. Pedersen, Denmark M. FitzGerald, Canada E. von Mutius, Germany

7. Science Committee: Objectives  Develop methods to track and evaluate new scientific research on asthma  Develop a process to evaluate impact of new scientific findings on GINA documents  Develop methods to track and evaluate new scientific research on asthma  Develop a process to evaluate impact of new scientific findings on GINA documents

8. Science Committee: Objectives (continued)   Identify a network of individuals to serve as ongoing reviewers   With the Dissemination Committee, develop methods to disseminate new scientific findings that impact on GINA documents   Identify a network of individuals to serve as ongoing reviewers   With the Dissemination Committee, develop methods to disseminate new scientific findings that impact on GINA documents

9. Dissemination Committee M. Partridge, UK, chair R. Neville, UK G. Anabwani, Botswana A. Sheffer, USA R. Beasley, N. Zealand J. Sinnadurai, Malaysia H. Campos, Brazil R. Singh, India Y. Chen, China W. Tan, Singapore F. Gallefoss, Norway R. Tomlins, Australia M. Haida, Japan O. van Schyack, Netherlands J. Khan, Pakistan H. Zar, S. Africa M. Partridge, UK, chair R. Neville, UK G. Anabwani, Botswana A. Sheffer, USA R. Beasley, N. Zealand J. Sinnadurai, Malaysia H. Campos, Brazil R. Singh, India Y. Chen, China W. Tan, Singapore F. Gallefoss, Norway R. Tomlins, Australia M. Haida, Japan O. van Schyack, Netherlands J. Khan, Pakistan H. Zar, S. Africa

10. Dissemination Committee: Objectives  Enhance dissemination of GINA reports  Ensure that all concerned with care of patients with asthma are knowledgeable about recommendations  Evaluate methods to alter health professional behaviour  Recommend methods to assess and monitor outcomes  Enhance dissemination of GINA reports  Ensure that all concerned with care of patients with asthma are knowledgeable about recommendations  Evaluate methods to alter health professional behaviour  Recommend methods to assess and monitor outcomes

11. GINA Documents   Workshop Report: Global Strategy for Asthma Management and Prevention (updated 2002)   Pocket guide for health care providers   Pocket guide for management of pediatric asthma (available mid-2002)   Guide for asthma patients and their families All materials are available on GINA web site www.ginasthma.com   Workshop Report: Global Strategy for Asthma Management and Prevention (updated 2002)   Pocket guide for health care providers   Pocket guide for management of pediatric asthma (available mid-2002)   Guide for asthma patients and their families All materials are available on GINA web site www.ginasthma.com

12. GINA Workshop Report   Developed during workshops conducted in cooperation with the National Heart, Lung, and Blood Institute, NIH and the World Health Organization  Evidence-based  Implementation oriented Diagnosis Management Prevention  Outcomes can be evaluated   Developed during workshops conducted in cooperation with the National Heart, Lung, and Blood Institute, NIH and the World Health Organization  Evidence-based  Implementation oriented Diagnosis Management Prevention  Outcomes can be evaluated

13. GINA Workshop Report Evidence Category Sources of Evidence A Randomized clinical trials Rich body of data B Randomized clinical trials Limited body of data C Non-randomized trials Observational studies D Panel judgment consensus Evidence Category Sources of Evidence A Randomized clinical trials Rich body of data B Randomized clinical trials Limited body of data C Non-randomized trials Observational studies D Panel judgment consensus

14. GINA Workshop Report Topics: Definition Definition Burden of Asthma Burden of Asthma Risk Factors Risk Factors Mechanisms Mechanisms Diagnosis and Classification Diagnosis and Classification Education and Delivery of Care Education and Delivery of Care Six Part Asthma Management Plan Six Part Asthma Management Plan Research Recommendations Research RecommendationsTopics: Definition Definition Burden of Asthma Burden of Asthma Risk Factors Risk Factors Mechanisms Mechanisms Diagnosis and Classification Diagnosis and Classification Education and Delivery of Care Education and Delivery of Care Six Part Asthma Management Plan Six Part Asthma Management Plan Research Recommendations Research Recommendations

15. Definition of Asthma A chronic inflammatory disorder of the airways Many cells and cellular elements play a role Chronic inflammation leads to an increase in airway hyperresponsiveness with recurrent episodes of wheezing, coughing, and shortness of breath Widespread, variable, and often reversible airflow limitation A chronic inflammatory disorder of the airways Many cells and cellular elements play a role Chronic inflammation leads to an increase in airway hyperresponsiveness with recurrent episodes of wheezing, coughing, and shortness of breath Widespread, variable, and often reversible airflow limitation

16. Definition of Asthma Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role Chronic inflammation causes an associated increase in airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning Chronic inflammation causes an associated increase in airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role Chronic inflammation causes an associated increase in airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning Chronic inflammation causes an associated increase in airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment

17. Mechanisms Underlying the Definition of Asthma Risk Factors (for development of asthma) Risk Factors (for development of asthma) INFLAMMATIONINFLAMMATION AirwayHyperresponsivenessAirwayHyperresponsiveness Airflow Obstruction Risk Factors Risk Factors (for exacerbations) Risk Factors Risk Factors (for exacerbations) SymptomsSymptoms

18. Burden of Asthma Asthma is one of the most common chronic diseases worldwide Asthma is one of the most common chronic diseases worldwide Prevalence increasing in many countries, especially in children Prevalence increasing in many countries, especially in children A major cause of school/work absence A major cause of school/work absence An overall increase in severity of asthma increases the pool of patients at risk for death An overall increase in severity of asthma increases the pool of patients at risk for death Asthma is one of the most common chronic diseases worldwide Asthma is one of the most common chronic diseases worldwide Prevalence increasing in many countries, especially in children Prevalence increasing in many countries, especially in children A major cause of school/work absence A major cause of school/work absence An overall increase in severity of asthma increases the pool of patients at risk for death An overall increase in severity of asthma increases the pool of patients at risk for death

19. Burden of Asthma Health care expenditures very high Health care expenditures very high Developed economies might expect to spend 1-2 percent of total health care expenditures on asthma. Developing economies likely to face increased demand Developed economies might expect to spend 1-2 percent of total health care expenditures on asthma. Developing economies likely to face increased demand Poorly controlled asthma is expensive; investment in prevention medication likely to yield cost savings in emergency care Poorly controlled asthma is expensive; investment in prevention medication likely to yield cost savings in emergency care Health care expenditures very high Health care expenditures very high Developed economies might expect to spend 1-2 percent of total health care expenditures on asthma. Developing economies likely to face increased demand Developed economies might expect to spend 1-2 percent of total health care expenditures on asthma. Developing economies likely to face increased demand Poorly controlled asthma is expensive; investment in prevention medication likely to yield cost savings in emergency care Poorly controlled asthma is expensive; investment in prevention medication likely to yield cost savings in emergency care

20. Worldwide Variation in Prevalence of Asthma Symptoms International Study of Asthma and Allergies in Children (ISAAC) Lancet 1998;351:1225 Worldwide Variation in Prevalence of Asthma Symptoms International Study of Asthma and Allergies in Children (ISAAC) Lancet 1998;351:1225

21. Increasing Prevalence of Asthma in Children/Adolescents 05101520253035 1992 1982 1989 1975 1992 1982 1994 1989 1992 1982 1992 1982 1991 1979 1989 1966 Finland (Haahtela et al) Sweden (Aberg et al) Japan (Nakagomi et al) Scotland (Rona et al) UK (Omran et al) USA(NHIS) New Zealand (Shaw et al) Australia (Peat et al) { Prevalence (%) { { { { { { {

22. Countries should enter their own data on burden of asthma. The following three slides are US data on prevalence, hospitalization rates and mortality.

23. 70 60 50 40 30 20 85868788899091929394 Rate/1,000 Persons Year <18 18-44 45-64 65+ Total (All Ages) <18 18-44 45-64 65+ Total (All Ages) Age (years) Trends in Prevalence of Asthma By Age, U.S., 1985-1996 9596 80

24. Hospitalization Rates for Asthma by Age, U.S., 1974 - 1997 40 35 30 25 20 15 7476788082848688 Rate/100,000 Persons 10 5 0 909294 <1515-4445-6465+ 96 Year

25. 4 3 1 1980 Year 2 0 1985 199019952000 Black Male White Female White Male Black Female Death Rates for Asthma By Race, Sex, U.S., 1980-1998 5

26. Risk Factors for Asthma Host factors: predispose individuals to, or protect them from, developing asthma Environmental factors: influence susceptibility to development of asthma in predisposed individuals, precipitate asthma exacerbations, and/or cause symptoms to persist Host factors: predispose individuals to, or protect them from, developing asthma Environmental factors: influence susceptibility to development of asthma in predisposed individuals, precipitate asthma exacerbations, and/or cause symptoms to persist

27. Factors that Exacerbate Asthma Allergens Allergens Air Pollutants Air Pollutants Respiratory infections Respiratory infections Exercise and hyperventilation Exercise and hyperventilation Weather changes Weather changes Sulfur dioxide Sulfur dioxide Food, additives, drugs Food, additives, drugs Allergens Allergens Air Pollutants Air Pollutants Respiratory infections Respiratory infections Exercise and hyperventilation Exercise and hyperventilation Weather changes Weather changes Sulfur dioxide Sulfur dioxide Food, additives, drugs Food, additives, drugs

28. Risk Factors that Lead to Asthma Development Host Factors  Genetic predisposition  Atopy  Airway hyper- responsiveness  Gender  Race/Ethnicity Host Factors  Genetic predisposition  Atopy  Airway hyper- responsiveness  Gender  Race/Ethnicity Environmental Factors Indoor allergens Outdoor allergens Occupational sensitizers Tobacco smoke Air Pollution Respiratory Infections Parasitic infections Socioeconomic factors Family size Diet and drugs Obesity Environmental Factors Indoor allergens Outdoor allergens Occupational sensitizers Tobacco smoke Air Pollution Respiratory Infections Parasitic infections Socioeconomic factors Family size Diet and drugs Obesity

29. Is it Asthma? Recurrent episodes of wheezing Recurrent episodes of wheezing Troublesome cough at night Troublesome cough at night Cough or wheeze after exercise Cough or wheeze after exercise Cough, wheeze or chest tightness after exposure to airborne allergens or pollutants Cough, wheeze or chest tightness after exposure to airborne allergens or pollutants Colds “go to the chest” or take more than 10 days to clear Colds “go to the chest” or take more than 10 days to clear Recurrent episodes of wheezing Recurrent episodes of wheezing Troublesome cough at night Troublesome cough at night Cough or wheeze after exercise Cough or wheeze after exercise Cough, wheeze or chest tightness after exposure to airborne allergens or pollutants Cough, wheeze or chest tightness after exposure to airborne allergens or pollutants Colds “go to the chest” or take more than 10 days to clear Colds “go to the chest” or take more than 10 days to clear

30. Asthma Diagnosis History and patterns of symptoms Physical examination Measurements of lung function Measurements of allergic status to identify risk factors History and patterns of symptoms Physical examination Measurements of lung function Measurements of allergic status to identify risk factors

31. Classification of Severity CLASSIFY SEVERITY Clinical Features Before Treatment Symptoms NocturnalSymptoms FEV 1 or PEF STEP 4 Severe Persistent STEP 3 Moderate Persistent STEP 2 Mild Persistent STEP 1 Intermittent Continuous Limited physical activity Daily Attacks affect activity > 1 time a week but 1 time a week but < 1 time a day < 1 time a week Asymptomatic and normal PEF between attacks Frequent > 1 time week > 2 times a month 2 times a month  2 times a month  60% predicted Variability > 30% 60 - 80% predicted Variability > 30%  80% predicted Variability 20 - 30%  80% predicted Variability < 20% The presence of one feature of severity is sufficient to place patient in that category.

32. 1. Educate Patients 2. Assess and Monitor Severity 3. Avoid Exposure to Risk Factors 4. Establish Medication Plans for Chronic Management: Adults and Children 5. Establish Plans for Managing Exacerbations 6. Provide Regular Follow-up Care 1. Educate Patients 2. Assess and Monitor Severity 3. Avoid Exposure to Risk Factors 4. Establish Medication Plans for Chronic Management: Adults and Children 5. Establish Plans for Managing Exacerbations 6. Provide Regular Follow-up Care Six-Part Asthma Management Program Six-Part Asthma Management Program

33. Six-Part Asthma Management Program 1.Educate patients to develop a partnership in asthma management 2.Assess and monitor asthma severity with symptom reports and measures of lung function as much as possible 3.Avoid exposure to risk factors 4.Establish medication plans for chronic management in children and adults 5.Establish individual plans for managing exacerbations 6.Provide regular follow-up care 1.Educate patients to develop a partnership in asthma management 2.Assess and monitor asthma severity with symptom reports and measures of lung function as much as possible 3.Avoid exposure to risk factors 4.Establish medication plans for chronic management in children and adults 5.Establish individual plans for managing exacerbations 6.Provide regular follow-up care

34. Six-part Asthma Management Program Goals of Long-term Management Achieve and maintain control of symptoms Prevent asthma episodes or attacks Maintain pulmonary function as close to normal levels as possible Maintain normal activity levels, including exercise Avoid adverse effects from asthma medications Prevent development of irreversible airflow limitation Prevent asthma mortality Achieve and maintain control of symptoms Prevent asthma episodes or attacks Maintain pulmonary function as close to normal levels as possible Maintain normal activity levels, including exercise Avoid adverse effects from asthma medications Prevent development of irreversible airflow limitation Prevent asthma mortality

35. Six-part Asthma Management Program Control of Asthma Minimal (ideally no) chronic symptoms Minimal (infrequent) exacerbations No emergency visits Minimal (ideally no) need for “as needed” use of β 2 -agonist No limitations on activities, including exercise PEF circadian variation of less than 20 percent (Near) normal PEF Minimal (or no) adverse effects from medicine Minimal (ideally no) chronic symptoms Minimal (infrequent) exacerbations No emergency visits Minimal (ideally no) need for “as needed” use of β 2 -agonist No limitations on activities, including exercise PEF circadian variation of less than 20 percent (Near) normal PEF Minimal (or no) adverse effects from medicine

36. Six-Part Asthma Management Program The most effective management is to prevent airway inflammation by eliminating the causal factors Asthma can be effectively controlled in most patients, although it can not be cured The major factors contributing to asthma morbidity and mortality are under- diagnosis and inappropriate treatment The most effective management is to prevent airway inflammation by eliminating the causal factors Asthma can be effectively controlled in most patients, although it can not be cured The major factors contributing to asthma morbidity and mortality are under- diagnosis and inappropriate treatment.

37. Six-Part Asthma Management Program Any asthma more severe than intermittent asthma is more effectively controlled by treatment to suppress and reverse airway inflammation than by treatment only of acute bronchoconstriction and symptoms

38. Six-part Asthma Management Program Part 1: Educate Patients to Develop a Partnership  Patient education involves a partnership between the patient and health care professional(s) with frequent revision and reinforcement  Aim is guided self-management – giving patients the ability to control their asthma  Interventions, including use of written action plans, have been shown to reduce morbidity in both children and adults  Patient education involves a partnership between the patient and health care professional(s) with frequent revision and reinforcement  Aim is guided self-management – giving patients the ability to control their asthma  Interventions, including use of written action plans, have been shown to reduce morbidity in both children and adults

39. Six-part Asthma Management Program Part 1: Educate Patients to Develop a Partnership  Guidelines on asthma management should be available but adapted and adopted for local use by local asthma planning teams  Clear communication between health care professionals and asthma patients is key to enhancing compliance  Guidelines on asthma management should be available but adapted and adopted for local use by local asthma planning teams  Clear communication between health care professionals and asthma patients is key to enhancing compliance

40. Six-part Asthma Management Program Part 1: Educate Patients to Develop a Partnership Educate continually Include the family Provide information about asthma Provide training on self-management skills Emphasize a partnership among health care providers, the patient, and the patient’s family Educate continually Include the family Provide information about asthma Provide training on self-management skills Emphasize a partnership among health care providers, the patient, and the patient’s family

41. Six-part Asthma Management Program Factors Associated with Non-Compliance in Asthma Care Medication Usage Difficulties associated with inhalers Complicated regimens Fears about, or actual side effects Cost Medication Usage Difficulties associated with inhalers Complicated regimens Fears about, or actual side effects Cost Patient/Physician Misunderstanding/lack of information Underestimation of severity Attitudes toward ill health Cultural factors Poor communication Patient/Physician Misunderstanding/lack of information Underestimation of severity Attitudes toward ill health Cultural factors Poor communication

42. Six-part Asthma Management Program Part 2: Assess and Monitor Asthma Severity with Symptom Reports and Measures of Lung Function Six-part Asthma Management Program Part 2: Assess and Monitor Asthma Severity with Symptom Reports and Measures of Lung Function Symptom reports Use of reliever medication Nighttime symptoms Activity limitations Spirometry for initial assessment. Peak Expiratory Flow for follow-up: Assess severity Assess response to therapy PEF monitoring at home Important for those with poor perception of symptoms Daily measurement recorded in a diary Assesses the severity and predicts worsening Guides the use of a zone system for asthma self-management Arterial blood gas for severe exacerbations Symptom reports Use of reliever medication Nighttime symptoms Activity limitations Spirometry for initial assessment. Peak Expiratory Flow for follow-up: Assess severity Assess response to therapy PEF monitoring at home Important for those with poor perception of symptoms Daily measurement recorded in a diary Assesses the severity and predicts worsening Guides the use of a zone system for asthma self-management Arterial blood gas for severe exacerbations

43. Typical Spirometric (FEV 1 ) Tracings 1 Time (sec) 2345 FEV 1 Volume Normal Subject Asthmatic (After Bronchodilator) Asthmatic (Before Bronchodilator) Note: Each FEV 1 curve represents the highest of three repeat measurements

44. A Simple Index of PEF Variation

45. Six-part Asthma Management Program Part 3: Avoid Exposure to Risk Factors  Methods to prevent onset of asthma are not yet available but this remains an important goal  Measures to reduce exposure to causes of asthma exacerbations (e.g. allergens, pollutants, foods and medications) should be implemented whenever possible  Methods to prevent onset of asthma are not yet available but this remains an important goal  Measures to reduce exposure to causes of asthma exacerbations (e.g. allergens, pollutants, foods and medications) should be implemented whenever possible

46. Six-part Asthma Management Program Part 4: Establish Medication Plans for Long-Term Asthma Management in Infants and Children  At present, inhaled glucocorticosteroids are the most effective controller medications and are recommended for persistent asthma at any step of severity  Long-term treatment with inhaled glucocorticosteroids markedly reduces the frequency and severity of exacerbations  At present, inhaled glucocorticosteroids are the most effective controller medications and are recommended for persistent asthma at any step of severity  Long-term treatment with inhaled glucocorticosteroids markedly reduces the frequency and severity of exacerbations

47. Six-part Asthma Management Program Part 3: Avoid Exposure to Risk Factors Reduce exposure to indoor allergens Reduce exposure to indoor allergens Avoid tobacco smoke Avoid tobacco smoke Avoid vehicle emission Avoid vehicle emission Identify irritants in the workplace Identify irritants in the workplace Explore role of infections on asthma development, especially in children and young infants Explore role of infections on asthma development, especially in children and young infants Reduce exposure to indoor allergens Reduce exposure to indoor allergens Avoid tobacco smoke Avoid tobacco smoke Avoid vehicle emission Avoid vehicle emission Identify irritants in the workplace Identify irritants in the workplace Explore role of infections on asthma development, especially in children and young infants Explore role of infections on asthma development, especially in children and young infants

48. Six-part Asthma Management Program Part 4: Establish Medication Plans for Long-Term Asthma Management Six-part Asthma Management Program Part 4: Establish Medication Plans for Long-Term Asthma Management A stepwise approach to pharmacological therapy is recommended A stepwise approach to pharmacological therapy is recommended The aim is to accomplish the goals of therapy with the least possible medication The aim is to accomplish the goals of therapy with the least possible medication Although in many countries traditional methods of healing are used, their efficacy has not yet been established and their use can therefore not be recommended Although in many countries traditional methods of healing are used, their efficacy has not yet been established and their use can therefore not be recommended A stepwise approach to pharmacological therapy is recommended A stepwise approach to pharmacological therapy is recommended The aim is to accomplish the goals of therapy with the least possible medication The aim is to accomplish the goals of therapy with the least possible medication Although in many countries traditional methods of healing are used, their efficacy has not yet been established and their use can therefore not be recommended Although in many countries traditional methods of healing are used, their efficacy has not yet been established and their use can therefore not be recommended

49. Part 4: Long-term Asthma Management Stepwise Approach to Asthma Therapy Part 4: Long-term Asthma Management Stepwise Approach to Asthma Therapy The choice of treatment should be guided by: Severity of the patient’s asthma Patient’s current treatment Pharmacological properties and availability of the various forms of asthma treatment Economic considerations Cultural preferences and differing health care. systems need to be considered. The choice of treatment should be guided by: Severity of the patient’s asthma Patient’s current treatment Pharmacological properties and availability of the various forms of asthma treatment Economic considerations Cultural preferences and differing health care. systems need to be considered.

50. Part 4: Long-term Asthma Management Pharmacologic Therapy Part 4: Long-term Asthma Management Pharmacologic Therapy Controller Medications: Inhaled glucocorticosteroids Systemic glucocorticosteroids Cromones Methylxanthines Long-acting inhaled β 2 -agonists Long-acting oral β 2 -agonists Leukotriene modifiers Controller Medications: Inhaled glucocorticosteroids Systemic glucocorticosteroids Cromones Methylxanthines Long-acting inhaled β 2 -agonists Long-acting oral β 2 -agonists Leukotriene modifiers

51. Part 4: Long-term Asthma Management Pharmacologic Therapy Reliever Medications: Rapid-acting inhaled β 2 -agonists Systemic glucocorticosteroids Anticholinergics Methylxanthines Short-acting oral β 2 -agonists Reliever Medications: Rapid-acting inhaled β 2 -agonists Systemic glucocorticosteroids Anticholinergics Methylxanthines Short-acting oral β 2 -agonists

52. Part 4: Long-term Asthma Management Stepwise Approach to Asthma Therapy - Adults Part 4: Long-term Asthma Management Stepwise Approach to Asthma Therapy - Adults Reliever:Rapid-acting inhaled β 2 -agonist prn Controller:   Daily inhaled corticosteroid Controller:   Daily inhaled corticosteroid   Daily long- acting inhaled β 2 -agonist Controller:   Daily inhaled corticosteroid   Daily long – acting inhaled β 2 -agonist   plus (if needed)   When asthma is controlled, reduce therapy   Monitor STEP 1: Intermittent STEP 2: Mild Persistent STEP 3: Moderate Persistent Moderate Persistent STEP 3: Moderate Persistent Moderate Persistent STEP 4: Severe Persistent STEP Down Outcome: Asthma Control Outcome: Best Possible Results Alternative controller and reliever medications may be considered (see text). Controller: None -Theophylline-SR -Leukotriene -Long-acting inhaled β 2 - agonist -Oral corticosteroid

53. Recommended Asthma Medications Step 1: Adults Severity Daily Controller Medications Other Options (in order of cost) Step 1: Intermittent None None Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

54. Recommended Asthma Medications Step 2: Adults Severity Daily Controller Medications Other Options (in order of cost) Step 2: Mild Persistent Inhaled glucocorticosteroid Inhaled glucocorticosteroid (< 500 μg BDP or equivalent) Sustained-release theophylline, or Sustained-release theophylline, or Cromone, or Cromone, or Leukotriene modifier Leukotriene modifier Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

55. Recommended Asthma Medications Step 3: Adults Severity Daily Controller Medications Other Options (in order of cost) Step 3: Moderate persistent Inhaled glucocorticosteroid Inhaled glucocorticosteroid (200 – 1000 μg BDP or equivalent) plus long-acting inhaled β 2 - agonist Inhaled glucocorticosteroid (500 – 1000 μg BDP or equivalent) plus sustained- release theophylline, or Inhaled glucocorticosteroid (500 – 1000 μg BDP or equivalent) plus sustained- release theophylline, or Inhaled glucocorticosteroid (500 – 1000 μg BDP or equivalent) plus long-acting inhaled β 2 - agonist, or Inhaled glucocorticosteroid (500 – 1000 μg BDP or equivalent) plus long-acting inhaled β 2 - agonist, or Inhaled glucocorticosteroid at higher doses (> 1000 μg BDP or equivalent), or Inhaled glucocorticosteroid at higher doses (> 1000 μg BDP or equivalent), or Inhaled glucocorticosteroid (500 – 1000 μg BDP or equivalent) plus leukotriene modifier Inhaled glucocorticosteroid (500 – 1000 μg BDP or equivalent) plus leukotriene modifier Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

56. Recommended Asthma Medications Step 4: Adults Severity Daily Controller Medications Other Options Step 4 Severe persistent Inhaled glucocorticosteroid Inhaled glucocorticosteroid ( > 1000 μg BDP or equivalent) plus long-acting inhaled β 2 - agonist plus one or more of the following, if needed: plus one or more of the following, if needed: - Sustained-release theophylline - Sustained-release theophylline - Leukotriene modifier - Leukotriene modifier - Long-acting inhaled β 2 - agonist - Long-acting inhaled β 2 - agonist - Oral glucocorticosteroid - Oral glucocorticosteroid Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

57. Part 4: Long-term Asthma Management Allergen-specific Immunotherapy Part 4: Long-term Asthma Management Allergen-specific Immunotherapy Greatest benefit of specific immunotherapy using allergen extracts has been obtained in the treatment of allergic rhinitis A number of questions must be addressed regarding the role of specific immunotherapy in asthma therapy Specific immunotherapy should be considered only after strict environmental avoidance and pharmacologic intervention, including inhaled glucocorticosteroids, have failed to control asthma Perform only by trained physician Greatest benefit of specific immunotherapy using allergen extracts has been obtained in the treatment of allergic rhinitis A number of questions must be addressed regarding the role of specific immunotherapy in asthma therapy Specific immunotherapy should be considered only after strict environmental avoidance and pharmacologic intervention, including inhaled glucocorticosteroids, have failed to control asthma Perform only by trained physician

58. Six-part Asthma Management Program Part 4: Establish Medication Plans for Long-Term Asthma Management in Infants and Children  Childhood and adult asthma share the same underlying mechanisms. However, because of processes of growth and development, effects of asthma treatments in children differ from those in adults.

59. Six-part Asthma Management Program Part 4: Establish Medication Plans for Long-Term Asthma Management in Infants and Children  Many asthma medications (e.g. glucocorticosteroids, β 2 - agonists, theophylline) are metabolized faster in children than in adults, and younger children tend to metabolize medications faster than older children

60. Six-part Asthma Management Program Part 4: Establish Medication Plans for Long-Term Asthma Management in Infants and Children  Long-term treatment with inhaled glucocorticosteroids has not been shown to be associated with any increase in osteoporosis or bone fracture  Studies including a total of over 3,500 children treated for periods of 1 – 13 years have found no sustained adverse effect of inhaled glucocorticosteroids on growth  Long-term treatment with inhaled glucocorticosteroids has not been shown to be associated with any increase in osteoporosis or bone fracture  Studies including a total of over 3,500 children treated for periods of 1 – 13 years have found no sustained adverse effect of inhaled glucocorticosteroids on growth

61. Six-part Asthma Management Program Part 4: Establish Medication Plans for Long-Term Asthma Management in Infants and Children  Rapid-acting inhaled β 2 - agonists are the most effective reliever therapy for children  These medications are the most effective bronchodilators available and are the treatment of choice for acute asthma symptoms  Rapid-acting inhaled β 2 - agonists are the most effective reliever therapy for children  These medications are the most effective bronchodilators available and are the treatment of choice for acute asthma symptoms

62. Recommended Asthma Medications Step 1: Children Severity Daily Controller Medications Other Options (in order of cost) Step 1: Intermittent None None Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

63. Recommended Asthma Medications Step 2: Children Severity Daily Controller Medications Other Options (in order of cost) Step 2: Mild Persistent Inhaled glucocorticosteroid Inhaled glucocorticosteroid (100 – 400 μg budesonide or equivalent) Sustained-release theophylline, or Sustained-release theophylline, or Cromone, or Cromone, or Leukotriene modifier Leukotriene modifier Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

64. Recommended Asthma Medications Step 3: Children Severity Daily Controller Medications Other Options (in order of cost) Step 3: Moderate persistent Inhaled glucocorticosteroid Inhaled glucocorticosteroid ( 400 – 800 μg budesonide or equivalent) Inhaled glucocorticosteroid (< 800 μg budesonide or equivalent) plus sustained-release theophylline, or Inhaled glucocorticosteroid (< 800 μg budesonide or equivalent) plus sustained-release theophylline, or Inhaled glucocorticosteroid (< 800 μg budesonide or equivalent) plus long- acting inhaled β 2 - agonist, or Inhaled glucocorticosteroid (< 800 μg budesonide or equivalent) plus long- acting inhaled β 2 - agonist, or Inhaled glucocorticosteroid at higher doses (> 800 μg budesonide or equivalent), or Inhaled glucocorticosteroid at higher doses (> 800 μg budesonide or equivalent), or Inhaled glucocorticosteroid (< 800 μg budesonide or equivalent) plus leukotriene modifier Inhaled glucocorticosteroid (< 800 μg budesonide or equivalent) plus leukotriene modifier Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

65. Recommended Asthma Medications Step 4: Children Severity Daily Controller Medications Other Options Other Options Step 4 Severe persistent Inhaled glucocorticosteroid Inhaled glucocorticosteroid ( > 800 μg budesonide or equivalent) plus one or more of the following, if needed: plus one or more of the following, if needed: - Sustained-release theophylline - Sustained-release theophylline - Leukotriene modifier - Leukotriene modifier - Long-acting inhaled β 2 - agonist - Long-acting inhaled β 2 - agonist - Oral glucocorticosteroid - Oral glucocorticosteroid Reliever Medication: Rapid-acting inhaled β 2 - agonist prn, not more than 3-4 times a day. Once control is achieved and maintained for at least 3 months, gradual reduction of therapy should be tried.

66. Six-part Asthma Management Program Part 5: Establish Plans for Managing Exacerbations Treatment of exacerbations depends on:  The patient  Experience of the health care professional  Therapies that are the most effective for the particular patient  Availability of medications  Emergency facilities Treatment of exacerbations depends on:  The patient  Experience of the health care professional  Therapies that are the most effective for the particular patient  Availability of medications  Emergency facilities

67. Six-part Asthma Management Program Part 5: Establish Plans for Managing Exacerbations Primary therapies for exacerbations: Repetitive administration of rapid-acting inhaled β 2 -agonist Early introduction of systemic glucocorticosteroids Oxygen supplementation Closely monitor response to treatment with serial measures of lung function Primary therapies for exacerbations: Repetitive administration of rapid-acting inhaled β 2 -agonist Early introduction of systemic glucocorticosteroids Oxygen supplementation Closely monitor response to treatment with serial measures of lung function

68. Six-part Asthma Management Program Part 5: Managing Severe Asthma Exacerbations  Severe exacerbations are life- threatening medical emergencies  Care must be expeditious and treatment is often most safely undertaken in a hospital or hospital-based emergency department  Severe exacerbations are life- threatening medical emergencies  Care must be expeditious and treatment is often most safely undertaken in a hospital or hospital-based emergency department

69. Emergency Department Management Acute Asthma Good Response Observe for at least 1 hour If Stable, Discharge to Home Initial Assessment History, Physical Examination, PEF or FEV 1 Initial Therapy Bronchodilators; O 2 if needed Incomplete/Poor Response Add Systemic Glucocorticosteroids Good Response Discharge Poor Response Admit to Hospital Respiratory Failure Admit to ICU

70. Six-part Asthma Management Program Part 6: Provide Regular Follow-up Care Continual monitoring is essential to assure that therapeutic goals are met. Frequent follow-up visits are necessary to review:  Home PEF and symptom records  Techniques in use of medications  Risk factors and their control Once asthma control is established, follow-up visits should be scheduled (at 1 to 6 month intervals as appropriate) Continual monitoring is essential to assure that therapeutic goals are met. Frequent follow-up visits are necessary to review:  Home PEF and symptom records  Techniques in use of medications  Risk factors and their control Once asthma control is established, follow-up visits should be scheduled (at 1 to 6 month intervals as appropriate)

71. Six-part Asthma Management Program Six-part Asthma Management Program Special Considerations Special considerations are required to manage asthma in relation to:  Pregnancy  Surgery  Physical activity  Rhinitis, sinusitis, and nasal polyps  Occupational asthma  Respiratory infections  Gastroesophageal reflux  Aspirin-induced asthma Special considerations are required to manage asthma in relation to:  Pregnancy  Surgery  Physical activity  Rhinitis, sinusitis, and nasal polyps  Occupational asthma  Respiratory infections  Gastroesophageal reflux  Aspirin-induced asthma

72. Six-part Asthma Management Program: Summary  Asthma can be effectively controlled, although it cannot be cured Effective asthma management programs include education, objective measures of lung function, environmental control, and pharmacologic therapy Effective asthma management programs include education, objective measures of lung function, environmental control, and pharmacologic therapy A stepwise approach to pharmacologic therapy is recommended. The aim is to accomplish the goals of therapy with the least possible medication A stepwise approach to pharmacologic therapy is recommended. The aim is to accomplish the goals of therapy with the least possible medication  Asthma can be effectively controlled, although it cannot be cured Effective asthma management programs include education, objective measures of lung function, environmental control, and pharmacologic therapy Effective asthma management programs include education, objective measures of lung function, environmental control, and pharmacologic therapy A stepwise approach to pharmacologic therapy is recommended. The aim is to accomplish the goals of therapy with the least possible medication A stepwise approach to pharmacologic therapy is recommended. The aim is to accomplish the goals of therapy with the least possible medication

73. Six-part Asthma Management Program: Summary (continued) Anything more than mild, occasional asthma is more effectively controlled by suppressing inflammation than by only treating acute bronchospasm Anything more than mild, occasional asthma is more effectively controlled by suppressing inflammation than by only treating acute bronchospasm The availability of varying forms of treatment, cultural preferences, and differing health care systems need to be considered The availability of varying forms of treatment, cultural preferences, and differing health care systems need to be considered Anything more than mild, occasional asthma is more effectively controlled by suppressing inflammation than by only treating acute bronchospasm Anything more than mild, occasional asthma is more effectively controlled by suppressing inflammation than by only treating acute bronchospasm The availability of varying forms of treatment, cultural preferences, and differing health care systems need to be considered The availability of varying forms of treatment, cultural preferences, and differing health care systems need to be considered

74. http://www.ginasthma.com

75. Optional Therapy Slides

76. Part 4: Long-term Asthma Management Stepwise Approach to Asthma Therapy - Adults Reliever:Rapid-acting inhaled β 2 -agonist prn Controller:   Daily inhaled corticosteroid Controller:   Daily inhaled corticosteroid   Daily long- acting inhaled β 2 -agonist Controller:   Daily inhaled corticosteroid   Daily long – acting inhaled β 2 -agonist   plus(if needed)   When asthma is controlled, reduce therapy   Monitor STEP 1: Intermittent STEP 2: Mild Persistent STEP 3: Moderate Persistent STEP 3: Moderate Persistent STEP 4: Severe Persistent STEP Down Outcome: Asthma Control Outcome: Best Possible Results Alternative controller and reliever medications may be considered (see text). Controller: None -Theophylline-SR -Leukotriene -Long-acting inhaled β 2 - agonist -Oral corticosteroid

77. Stepwise Approach to Asthma Therapy: Adults Step 1: Intermittent Asthma None required Rapid-acting inhaled  2 -agonist for symptoms (but < once a week) Rapid-acting inhaled  2 -agonist, cromone, or leukotriene modifier before exercise or exposure to allergen  Continuously review medication technique, compliance and environmental control  Review treatment every three months.  Step up if control is not achieved; step down if control is sustained for at least 3 months  Preferred treatments are in bold print Daily Controller Medications Reliever Medications

78. Inhaled glucocorticosteroid (< 500 μg BDP or equivalent) Other options (order by cost):   sustained-release theophylline, or   Cromone, or   leukotriene modifier Rapid-acting inhaled  2 -agonist for symptoms (but < 3-4 times/day) Other options:   inhaled anticholinergic, or   short-acting oral  2 -agonist, or   short-acting theophylline  Continuously review medication technique, compliance and environmental control.  Review treatment every three months  Step up if control is not achieved; Step down if control is sustained for at least 3 months  Preferred treatments are in bold print Stepwise Approach to Asthma Therapy: Adults Step 2: Mild Persistent Asthma Daily Controller Medications Reliever Medications

79. Inhaled glucocorticosteroid, (200 – 1000 μg BDP or equivalent) plus long-acting inhaled β 2 agonist Other options (order by cost):   Inhaled glucocorticosteroid (500 – 1000 μg BDP equivalent) plus sustained-release theophylline, or   Inhaled glucocorticosteroid (500 – 1000 μg BDP equivalent) plus long-acting inhaled β 2 - agonist, or   inhaled glucocorticosteroid at higher doses (> 1000 μg BDP equivalent), or   Inhaled glucocorticosteroid (500 – 1000 μg BDP equivalent) plus leukotriene modifier Rapid-acting inhaled  2 -agonist for symptoms (but < 3 - 4 times/day) Other options:   inhaled anticholinergic or   short-acting oral  2 -agonist or   short-acting theophylline  Continuously review medication technique, compliance and environmental control.  Review treatment every three months.  Step up if control is not achieved; Step down if control is sustained for at least 3 months.  Preferred treatments are in bold print. Stepwise Approach to Asthma Therapy: Adults Step 3: Moderate Persistent Asthma Daily Controller Medications Reliever Medications

80. Inhaled glucocorticosteroid, (> 1000 μg BDP or equivalent) plus long-acting inhaled β 2 agonist plus one or more of the following, if needed (order by cost):   sustained-release theophylline, or   leukotriene modifier or   oral glucocorticosteroid Rapid-acting inhaled  2 -agonist for symptoms (but < 3-4 times/day) Other options:   inhaled anticholinergic or   short-acting oral  2 -agonist or   short-acting theophylline  Continuously review medication technique, compliance and environmental control.  Review treatment every three months.  Step up if control is not achieved; Step down if control is sustained for at least 3 months.  Preferred treatments are in bold print. Stepwise Approach to Asthma Therapy: Adults Step 4: Severe Persistent Asthma Daily Controller Medications Reliever Medications