G IN A lobal itiative for sthma

GINA 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

Executive Committee Chair: Paul O’Byrne, MD GINA Structure Executive Committee Chair: Paul O’Byrne, MD Science Committee Chair: Eric Bateman, MD Dissemination/Implementation Task Group Chair: Wan Tan, MD

GINA Executive Committee P. O’Byrne, Chair, Canada E. Bateman, S. Africa S. Pedersen, Denmark J. Bousquet, France R. Singh, India T. Clark, UK M. Soto-Quiroz, Costa Rica K. Ohta, Japan W. Tan, Canada P. Paggario, Italy

GINA Science Committee E. Bateman, Chair, S. Africa P. Barnes, UK K. Ohta, Japan J. Bousquet, France S. Pedersen, Denmark J. Drazen, US E. Pizzichini, Brazil M. FitzGerald, Canada S. Sullivan, US P. Gibson, Australia S. Wenzel, US P. O’Byrne, Canada H. Zar, S. Africa

Executive Committee Chair: Paul O’Byrne, MD GINA Structure Executive Committee Chair: Paul O’Byrne, MD Science Committee Chair: Eric Bateman, MD Dissemination/Implementation Task Group Chair: Wan Tan, MD GINA ASSEMBLY

GINA Assembly A network of individuals participating in the dissemination and implementation of asthma management programs at the local, national and regional level GINA Assembly members are invited to meet with the GINA Executive Committee during the ATS and ERS meetings

GINA Assembly Slovenia Germany Ireland Australia Yugoslavia Croatia Bangladesh Saudi Arabia Slovenia Germany Ireland Australia Yugoslavia Croatia Canada Brazil Austria Taiwan ROC United States Thailand Portugal Malta Greece Moldova Mexico China Syria South Africa United Kingdom Hong Kong Italy New Zealand Chile Venezuela Argentina Israel Lebanon Pakistan Japan GINA Assembly Poland Korea Netherlands Switzerland Russia Georgia Macedonia France Czech Republic Denmark Turkey Slovakia Belgium Singapore Spain Colombia Ukraine Romania India Sweden Vietnam Albania Kyrgyzstan

GINA Documents Global Strategy for Asthma Management and Prevention (revised 2006) Pocket Guide: Asthma Management and Prevention (revised 2006) Pocket Guide: Asthma Management and Prevention in Children (revised 2006) Guide for asthma patients and families All materials are available on GINA web site www.ginasthma.org

Global Strategy for Asthma Management and Prevention Evidence-based Implementation oriented Diagnosis Management Prevention Outcomes can be evaluated

Global Strategy for Asthma Management and Prevention 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

Global Strategy for Asthma Management and Prevention (2006) Definition and Overview Diagnosis and Classification Asthma Medications Asthma Management and Prevention Program Implementation of Asthma Guidelines in Health Systems Revised 2006

Definition of Asthma A chronic inflammatory disorder of the airways Many cells and cellular elements play a role Chronic inflammation is associated with airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing Widespread, variable, and often reversible airflow limitation

Asthma Inflammation: Cells and Mediators Source: Peter J. Barnes, MD

Mechanisms: Asthma Inflammation Source: Peter J. Barnes, MD

Asthma Inflammation: Cells and Mediators Source: Peter J. Barnes, MD

Burden of Asthma Asthma is one of the most common chronic diseases worldwide with an estimated 300 million affected individuals Prevalence increasing in many countries, especially in children A major cause of school/work absence

Burden of Asthma 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 Poorly controlled asthma is expensive; investment in prevention medication likely to yield cost savings in emergency care

Asthma Prevalence and Mortality Source: Masoli M et al. Allergy 2004

Countries should enter their own data on burden of asthma.

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

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

Factors that Influence Asthma Development and Expression Host Factors Genetic - Atopy - Airway hyperresponsiveness Gender Obesity Environmental Factors Indoor allergens Outdoor allergens Occupational sensitizers Tobacco smoke Air Pollution Respiratory Infections Diet

Is it Asthma? Recurrent episodes of wheezing Troublesome cough at night Cough or wheeze after exercise 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

Asthma Diagnosis History and patterns of symptoms Measurements of lung function - Spirometry - Peak expiratory flow Measurement of airway responsiveness Measurements of allergic status to identify risk factors Extra measures may be required to diagnose asthma in children 5 years and younger and the elderly

Typical Spirometric (FEV1) Tracings Volume FEV1 Normal Subject Asthmatic (After Bronchodilator) Asthmatic (Before Bronchodilator) 1 2 3 4 5 Time (sec) Note: Each FEV1 curve represents the highest of three repeat measurements

Measuring Variability of Peak Expiratory Flow

Measuring Airway Responsiveness

Clinical Control of Asthma No (or minimal)* daytime symptoms No limitations of activity No nocturnal symptoms No (or minimal) need for rescue medication Normal lung function No exacerbations _________ * Minimal = twice or less per week

Levels of Asthma Control Characteristic Controlled (All of the following) Partly controlled (Any present in any week) Uncontrolled Daytime symptoms None (2 or less / week) More than twice / week 3 or more features of partly controlled asthma present in any week Limitations of activities None Any Nocturnal symptoms / awakening Need for rescue / “reliever” treatment More than twice / week Lung function (PEF or FEV1) Normal < 80% predicted or personal best (if known) on any day Exacerbation One or more / year 1 in any week

Asthma Management and Prevention Program: Five Components Revised 2006 1. Develop Patient/Doctor Partnership 2. Identify and Reduce Exposure to Risk Factors 3. Assess, Treat and Monitor Asthma 4. Manage Asthma Exacerbations 5. Special Considerations

1. Develop Patient/Doctor Partnership Asthma Management and Prevention Program: Five Interrelated Components 1. Develop Patient/Doctor Partnership 2. Identify and Reduce Exposure to Risk Factors 3. Assess, Treat and Monitor Asthma 4. Manage Asthma Exacerbations 5. Special Considerations

Goals of Long-term Management Asthma Management and Prevention Program Goals of Long-term Management Achieve and maintain control of symptoms Maintain normal activity levels, including exercise Maintain pulmonary function as close to normal levels as possible Prevent asthma exacerbations Avoid adverse effects from asthma medications Prevent asthma mortality

. Asthma Management and Prevention Program Asthma can be effectively controlled in most patients by intervening to suppress and reverse inflammation as well as treating bronchoconstriction and related symptoms Early intervention to stop exposure to the risk factors that sensitized the airway may help improve the control of asthma and reduce medication needs.

Asthma Management and Prevention Program Although there is no cure for asthma, appropriate management that includes a partnership between the physician and the patient/family most often results in the achievement of control

Asthma Management and Prevention Program Component 1: Develop Patient/Doctor 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

Provide information about asthma Asthma Management and Prevention Program Component 1: Develop Patient/Doctor 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

Key factors to facilitate communication: Friendly demeanor Asthma Management and Prevention Program Component 1: Develop Patient/Doctor Partnership Key factors to facilitate communication: Friendly demeanor Interactive dialogue Encouragement and praise Provide appropriate information Feedback and review

Example Of Contents Of An Action Plan To Maintain Asthma Control Your Regular Treatment: 1. Each day take ___________________________ 2. Before exercise, take _____________________ WHEN TO INCREASE TREATMENT Assess your level of Asthma Control In the past week have you had: Daytime asthma symptoms more than 2 times ? No Yes Activity or exercise limited by asthma? No Yes Waking at night because of asthma? No Yes The need to use your [rescue medication] more than 2 times? No Yes If you are monitoring peak flow, peak flow less than________? No Yes If you answered YES to three or more of these questions, your asthma is uncontrolled and you may need to step up your treatment. HOW TO INCREASE TREATMENT STEP-UP your treatment as follows and assess improvement every day: ____________________________________________ [Write in next treatment step here] Maintain this treatment for _____________ days [specify number] WHEN TO CALL THE DOCTOR/CLINIC. Call your doctor/clinic: _______________ [provide phone numbers] If you don’t respond in _________ days [specify number] ______________________________ [optional lines for additional instruction] EMERGENCY/SEVERE LOSS OF CONTROL If you have severe shortness of breath, and can only speak in short sentences, If you are having a severe attack of asthma and are frightened, If you need your reliever medication more than every 4 hours and are not improving. 1. Take 2 to 4 puffs ___________ [reliever medication] 2. Take ____mg of ____________ [oral glucocorticosteroid] 3. Seek medical help: Go to _____________________; Address___________________ Phone: _______________________ 4. Continue to use your _________[reliever medication] until you are able to get medical help.

Non-Medication Factors Asthma Management and Prevention Program Factors Involved in Non-Adherence Medication Usage Difficulties associated with inhalers Complicated regimens Fears about, or actual side effects Cost Distance to pharmacies Non-Medication Factors Misunderstanding/lack of information Fears about side-effects Inappropriate expectations Underestimation of severity Attitudes toward ill health Cultural factors Poor communication

Component 2: Identify and Reduce Exposure to Risk Factors Asthma Management and Prevention Program Component 2: Identify and Reduce Exposure to Risk Factors Measures to prevent the development of asthma, and asthma exacerbations by avoiding or reducing exposure to risk factors should be implemented wherever possible. Asthma exacerbations may be caused by a variety of risk factors – allergens, viral infections, pollutants and drugs. Reducing exposure to some categories of risk factors improves the control of asthma and reduces medications needs.

Reduce exposure to indoor allergens Avoid tobacco smoke Asthma Management and Prevention Program Component 2: Identify and Reduce Exposure to Risk Factors Reduce exposure to indoor allergens Avoid tobacco smoke Avoid vehicle emission Identify irritants in the workplace Explore role of infections on asthma development, especially in children and young infants

Influenza Vaccination Asthma Management and Prevention Program Influenza Vaccination Influenza vaccination should be provided to patients with asthma when vaccination of the general population is advised However, routine influenza vaccination of children and adults with asthma does not appear to protect them from asthma exacerbations or improve asthma control

Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma The goal of asthma treatment, to achieve and maintain clinical control, can be achieved in a majority of patients with a pharmacologic intervention strategy developed in partnership between the patient/family and the health care professional

- Assessing Asthma Control - Treating to Achieve Control Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma Depending on level of asthma control, the patient is assigned to one of five treatment steps Treatment is adjusted in a continuous cycle driven by changes in asthma control status. The cycle involves: - Assessing Asthma Control - Treating to Achieve Control - Monitoring to Maintain Control

A stepwise approach to pharmacological therapy is recommended Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma A stepwise approach to pharmacological therapy is recommended 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

The choice of treatment should be guided by: Level of asthma control Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma The choice of treatment should be guided by: Level of asthma control 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

Levels of Asthma Control Characteristic Controlled Partly controlled (Any present in any week) Uncontrolled Daytime symptoms None (2 or less / week) More than twice / week 3 or more features of partly controlled asthma present in any week Limitations of activities None Any Nocturnal symptoms / awakening Need for rescue / “reliever” treatment More than twice / week Lung function (PEF or FEV1) Normal < 80% predicted or personal best (if known) on any day Exacerbation One or more / year 1 in any week

The choice of treatment should be guided by: Level of asthma control Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma The choice of treatment should be guided by: Level of asthma control 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

Controller Medications Component 4: Asthma Management and Prevention Program Controller Medications Inhaled glucocorticosteroids Leukotriene modifiers Long-acting inhaled β2-agonists Systemic glucocorticosteroids Theophylline Cromones Long-acting oral β2-agonists Anti-IgE

Estimate Comparative Daily Dosages for Inhaled Glucocorticosteroids by Age Drug Low Daily Dose (g) Medium Daily Dose (g) High Daily Dose (g) > 5 y Age < 5 y > 5 y Age < 5 y > 5 y Age < 5 y Beclomethasone 200-500 100-200 >500-1000 >200-400 >1000 >400 Budesonide 200-600 100-200 600-1000 >200-400 >1000 >400 Budesonide-Neb Inhalation Suspension 250-500 >500-1000 >1000 Ciclesonide 80 – 160 80-160 >160-320 >160-320 >320-1280 >320 Flunisolide 500-1000 500-750 >1000-2000 >750-1250 >2000 >1250 Fluticasone 100-250 100-200 >250-500 >200-500 >500 >500 Mometasone furoate 200-400 100-200 > 400-800 >200-400 >800-1200 >400 Triamcinolone acetonide 400-1000 400-800 >1000-2000 >800-1200 >2000 >1200

Reliever Medications Rapid-acting inhaled β2-agonists Component 4: Asthma Management and Prevention Program Reliever Medications Rapid-acting inhaled β2-agonists Systemic glucocorticosteroids Anticholinergics Theophylline Short-acting oral β2-agonists

The role of specific immunotherapy in asthma is limited Component 4: Asthma Management and Prevention Program Allergen-specific Immunotherapy Greatest benefit of specific immunotherapy using allergen extracts has been obtained in the treatment of allergic rhinitis The role of specific immunotherapy in asthma is limited 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

1 2 3 4 5 LEVEL OF CONTROL TREATMENT OF ACTION TREATMENT STEPS REDUCE controlled partly controlled uncontrolled exacerbation LEVEL OF CONTROL maintain and find lowest controlling step consider stepping up to gain control step up until controlled treat as exacerbation TREATMENT OF ACTION INCREASE TREATMENT STEPS REDUCE INCREASE STEP 1 2 3 4 5

Step 1 – As-needed reliever medication Treating to Achieve Asthma Control Step 1 – As-needed reliever medication Patients with occasional daytime symptoms of short duration A rapid-acting inhaled β2-agonist is the recommended reliever treatment (Evidence A) When symptoms are more frequent, and/or worsen periodically, patients require regular controller treatment (step 2 or higher)

Treating to Achieve Asthma Control Step 2 – Reliever medication plus a single controller A low-dose inhaled glucocorticosteroid is recommended as the initial controller treatment for patients of all ages (Evidence A) Alternative controller medications include leukotriene modifiers (Evidence A) appropriate for patients unable/unwilling to use inhaled glucocorticosteroids

Treating to Achieve Asthma Control Step 3 – Reliever medication plus one or two controllers For adults and adolescents, combine a low-dose inhaled glucocorticosteroid with an inhaled long-acting β2-agonist either in a combination inhaler device or as separate components (Evidence A) Inhaled long-acting β2-agonist must not be used as monotherapy For children, increase to a medium-dose inhaled glucocorticosteroid (Evidence A)

Treating to Achieve Asthma Control Additional Step 3 Options for Adolescents and Adults Increase to medium-dose inhaled glucocorticosteroid (Evidence A) Low-dose inhaled glucocorticosteroid combined with leukotriene modifiers (Evidence A) Low-dose sustained-release theophylline (Evidence B)

Treating to Achieve Asthma Control Step 4 – Reliever medication plus two or more controllers Selection of treatment at Step 4 depends on prior selections at Steps 2 and 3 Where possible, patients not controlled on Step 3 treatments should be referred to a health professional with expertise in the management of asthma

Treating to Achieve Asthma Control Step 4 – Reliever medication plus two or more controllers Medium- or high-dose inhaled glucocorticosteroid combined with a long-acting inhaled β2-agonist (Evidence A) Medium- or high-dose inhaled glucocorticosteroid combined with leukotriene modifiers (Evidence A) Low-dose sustained-release theophylline added to medium- or high-dose inhaled glucocorticosteroid combined with a long-acting inhaled β2-agonist (Evidence B)

Treating to Achieve Asthma Control Step 5 – Reliever medication plus additional controller options Addition of oral glucocorticosteroids to other controller medications may be effective (Evidence D) but is associated with severe side effects (Evidence A) Addition of anti-IgE treatment to other controller medications improves control of allergic asthma when control has not been achieved on other medications (Evidence A)

Treating to Maintain Asthma Control When control as been achieved, ongoing monitoring is essential to: - maintain control - establish lowest step/dose treatment Asthma control should be monitored by the health care professional and by the patient

Treating to Maintain Asthma Control Stepping down treatment when asthma is controlled When controlled on medium- to high-dose inhaled glucocorticosteroids: 50% dose reduction at 3 month intervals (Evidence B) When controlled on low-dose inhaled glucocorticosteroids: switch to once-daily dosing (Evidence A)

Treating to Maintain Asthma Control Stepping down treatment when asthma is controlled When controlled on combination inhaled glucocorticosteroids and long-acting inhaled β2-agonist, reduce dose of inhaled glucocorticosteroid by 50% while continuing the long-acting β2-agonist (Evidence B) If control is maintained, reduce to low-dose inhaled glucocorticosteroids and stop long-acting β2-agonist (Evidence D)

Treating to Maintain Asthma Control Stepping up treatment in response to loss of control Rapid-onset, short-acting or long-acting inhaled β2-agonist bronchodilators provide temporary relief. Need for repeated dosing over more than one/two days signals need for possible increase in controller therapy

Treating to Maintain Asthma Control Stepping up treatment in response to loss of control Use of a combination rapid and long-acting inhaled β2-agonist (e.g., formoterol) and an inhaled glucocorticosteroid (e.g., budesonide) in a single inhaler both as a controller and reliever is effecting in maintaining a high level of asthma control and reduces exacerbations (Evidence A) Doubling the dose of inhaled glucocortico-steroids is not effective, and is not recommended (Evidence A)

Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger 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.

Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger Many asthma medications (e.g. glucocorticosteroids, β2- agonists, theophylline) are metabolized faster in children than in adults, and younger children tend to metabolize medications faster than older children

Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger 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

Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger Rapid-acting inhaled β2-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

Asthma Management and Prevention Program Component 4: Manage Asthma Exacerbations Exacerbations of asthma are episodes of progressive increase in shortness of breath, cough, wheezing, or chest tightness Exacerbations are characterized by decreases in expiratory airflow that can be quantified and monitored by measurement of lung function (FEV1 or PEF) Severe exacerbations are potentially life-threatening and treatment requires close supervision

Treatment of exacerbations depends on: The patient Asthma Management and Prevention Program Component 4: Manage Asthma 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

Primary therapies for exacerbations: Asthma Management and Prevention Program Component 4: Manage Asthma Exacerbations Primary therapies for exacerbations: Repetitive administration of rapid-acting inhaled β2-agonist Early introduction of systemic glucocorticosteroids Oxygen supplementation Closely monitor response to treatment with serial measures of lung function

Asthma Management and Prevention Program Special Considerations Special considerations are required to manage asthma in relation to: Pregnancy Surgery Rhinitis, sinusitis, and nasal polyps Occupational asthma Respiratory infections Gastroesophageal reflux Aspirin-induced asthma Anaphylaxis and Asthma

Asthma Management and Prevention Program: Summary Asthma can be effectively controlled in most patients by intervening to suppress and reverse inflammation as well as treating bronchoconstriction and related symptoms Although there is no cure for asthma, appropriate management that includes a partnership between the physician and the patient/family most often results in the achievement of control

Asthma Management and Prevention Program: Summary A stepwise approach to pharmacologic therapy is recommended. The aim is to accomplish the goals of therapy with the least possible medication The availability of varying forms of treatment, cultural preferences, and differing health care systems need to be considered

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Alternate Slides for Asthma Treatment

Levels of Asthma Control Characteristic Controlled (All of the following) Partly Controlled (Any measure present in any week) Uncontrolled Daytime symptoms None (twice or less/week) More than twice/week Three or more features of partly controlled asthma present in any week Limitations of activities None Any Nocturnal symptoms/awakening Need for reliever/ rescue treatment Lung function (PEF or FEV1) Normal < 80% predicted or personal best (if known) Exacerbations One or more/year* One in any week† * Any exacerbation should prompt review of maintenance treatment to ensure that it is adequate. † By definition, an exacerbation in any week makes that an uncontrolled asthma week.

Asthma Control: Treatment Steps Children Older than Five Years, Adolescents, Adults

Example Of Contents Of An Action Plan To Maintain Asthma Control Your Regular Treatment: 1. Each day take ___________________________ 2. Before exercise, take _____________________ WHEN TO INCREASE TREATMENT Assess your level of Asthma Control In the past week have you had: Daytime asthma symptoms more than 2 times ? No Yes Activity or exercise limited by asthma? No Yes Waking at night because of asthma? No Yes The need to use your [rescue medication] more than 2 times? No Yes If you are monitoring peak flow, peak flow less than________? No Yes If you answered YES to three or more of these questions, your asthma is uncontrolled and you may need to step up your treatment. HOW TO INCREASE TREATMENT STEP-UP your treatment as follows and assess improvement every day: ____________________________________________ [Write in next treatment step here] Maintain this treatment for _____________ days [specify number] WHEN TO CALL THE DOCTOR/CLINIC. Call your doctor/clinic: _______________ [provide phone numbers] If you don’t respond in _________ days [specify number] ______________________________ [optional lines for additional instruction] EMERGENCY/SEVERE LOSS OF CONTROL If you have severe shortness of breath, and can only speak in short sentences, If you are having a severe attack of asthma and are frightened, If you need your reliever medication more than every 4 hours and are not improving. 1. Take 2 to 4 puffs ___________ [reliever medication] 2. Take ____mg of ____________ [oral glucocorticosteroid] 3. Seek medical help: Go to _____________________; Address___________________ Phone: _______________________ 4. Continue to use your _________[reliever medication] until you are able to get medical help.