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Module 5: Treatment of Severe Asthma an educational program of: Updated: June 2011 Sponsored by an unrestricted educational grant from Global Resources in Allergy (GLORIA™) Global Resources In Allergy (GLORIA™) is the flagship program of the World Allergy Organization (WAO). Its curriculum educates medical professionals worldwide through regional and national presentations. GLORIA modules are created from established guidelines and recommendations to address different aspects of allergy-related patient care. World Allergy Organization (WAO) The World Allergy Organization is an international coalition of 89 regional and national allergy and clinical immunology societies. WAO’s Mission WAO’s mission is to be a global resource and advocate in the field of allergy, advancing excellence in clinical care, education, research and training through a world-wide alliance of allergy and clinical immunology societies Module 5: Treatment of Severe Asthma Authors: Jean Bousquet, France Ronald Dahl, Denmark Michael A. Kaliner, USA Connie Katelaris, Australia Contributer: Richard Lockey, USA Severe asthma • A shift in focus from severity to control • How to control severe asthma • Diagnosis and management of acute severe asthma Section 1: Asthma Control Lecture Objectives Section 1 – Asthma Control At the end of this section participants will be able to: • Diagnose severe asthma • Assess whether asthma is controlled • Outline appropriate treatment strategies for optimal control of severe asthma Definition of severe asthma • Patients who need high dose inhaled CCS and longacting ß2 agonists and: – are still uncontrolled – experience frequent acute exacerbations – and/or often require emergency treatment and/or hospitalization Diagnosis and classification of asthma Asthma severity is classified by: • the presence of clinical features before treatment is started • and/or by the amount of daily medication required for optimal treatment GINA 2002 Classification of asthma: GINA 1998 Current treatment step Step 1 Step 2 Step 3 Step 4 Clinical features No controller <500 BDP 200–1000 BDP + LABA >1000 BDP + LABA + other Step 1 Symptoms <1 x week Intermittent Mild persistent Moderate persistent Severe persistent Mild persistent Moderate persistent Severe persistent Severe persistent Moderate persistent Severe persistent Severe persistent Severe persistent Severe persistent Severe persistent Severe persistent Severe persistent Nocturnal symptoms ≤2x month Lung function normal between episodes Step 2 Symptoms >1 x week Nocturnal symptoms <1 x week Lung function normal between episodes Step 3 Symptoms daily Nocturnal symptoms ≥1 x week FEV1 60–80% predicted Step 4 Symptoms daily Frequent nocturnal symptoms FEV1 <60% predicted Asthma management: from severity to control There has been a shift in the paradigm for asthma treatment; previous recommendations for stepwise implementation of pharmacotherapy were based on disease severity, the focus is now on asthma control GINA: goals of treatment 2006 "The aim of asthma management should be control of the disease" GINA 2002 What is asthma control? • To the patient – no symptoms which interfere with normal lifestyle no exacerbations, normal quality-of-life – particularly, no cough • To carers (parents) – able to get to school, no night cough • To the GP – no unscheduled visits, few exacerbations, no admissions (sometimes maintenance of PEF) What is asthma control? • To the respiratory physician – no night symptoms – maintenance of lung function (FEV1) – few exacerbations, no admissions • To regulatory authorities – improvement in a.m. PEF, FEV1 – improvement in symptom scores and quality of life – enhanced cost effectiveness analyses A composite measure of control may help to improve outcomes • Currently, single clinical endpoints, such as lung function, are often used to guide treatment • Single endpoints may overestimate true asthma control1 • Other disease areas such as diabetes use a composite measure (HbA1c, blood pressure and cholesterol targets)2-4 1. Clark et al. Eur Respir J 2002 2. European Diabetes Policy Group 1999. Diabet Med 1999 3. Diabetes UK. Recommendations for the management of diabetes in primary care. 2nd ed. October 2000 4. Department of Health. NSF for Diabetes: Standards 5. British Thoracic Society/Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma. February 2003. 6. National Heart, Lung, and Blood Institute, World Health Organization. 1998 How can we assess control in practice? We need simple tools that both healthcare providers and patients can use – Asthma Control Questionnaire (ACQ) 7-item questionnaire. Based upon day/night-time symptoms, daily activities, rescue bronchodilator Juniper et al ERJ 1999; 14: 902-907 How can we assess control in practice ? - Royal College of Physicians (RCP) 3 questions based upon day/night-time symptoms and daily activities. - Asthma Control Test (ACT) Validated instrument. 5 questions based upon day/night-time symptoms, rescue bronchodilator use and daily activities. Br Med J 1990;301:651-653 Nathan et al., J Allergy Clin Immun, 2004: 113(1): 59-65 Differences between scores RCP rules 2 ACQ ACT 30 sec Night time symptoms yes yes yes yes yes Day time symptoms yes yes yes yes Exercise, activities yes yes yes yes Rescue medications (yes) yes yes yes 1 mo 1 wk to 3 mo yes FEV1 or PEFR Duration of survey ACQ7 1 wk or 1 mo 1 wk to 1 yr 1 wk Levels of asthma control Characteristic Controlled (All of the following) Partly controlled (Any present in any week) Daytime symptoms None (2 or less/ week) More than twice/week Limitations of activities None Any Nocturnal symptoms/ awakening None Any Need for rescue/ “reliever” treatment None (2 or less/ week) More than twice/week Lung function (PEF or FEV1) Normal < 80% predicted or personal best (if known) on any day Exacerbation None One or more/year Uncontrolled 3 or more features of partly controlled asthma present in any week 1 in any week 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 Severe asthma • A shift in focus from severity to control • How to control severe asthma • Diagnosis and management of acute severe asthma 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 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 Management of asthma in adults and adolescents (GINA 2006 adapted) Assess asthma control Controlled Partially controlled Uncontrolled Exacerbation Maintain treatment or Step down No controller treatment Controller treatment Step 2 Step up Step up until controlled Treat as exacerbation 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 longacting 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 of 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 long-acting inhaled β2-agonist (e.g., salmeterol, formoterol) and an inhaled glucocorticosteroid (e.g., fluticasone, budesonide) in a single inhaler both as a controller and reliever is effective in maintaining a high level of asthma control and reduces exacerbations (Evidence A) • Doubling the dose of inhaled glucocorticosteroids is not effective, and is not recommended (Evidence A) Treating to maintain asthma control • When control as been achieved, ongoing monitoring is essential to: - maintain control - establish lowest step/dose of treatment • Asthma control should be monitored by the health care professional and by the patient Guided self-management plans GINA 2006 (adapted) • Guided self management action plans enable patients with asthma to gain the knowledge, confidence and skills to assume a major role in the management of their asthma, reducing asthma morbidity in adults (Evidence A) and children (Evidence A). Monitoring asthma: peak flow meters Peak flow meters are useful to monitor asthma and prevent exacerbations: • • • • Inexpensive Easy to use Accurate Provide “real life” measurements at worst and best times of the day • Provide objective measurement of pulmonary function • Detect early changes of asthma worsening Patient “self management” based on peak flow measurement If personal best peak flow measurements: – Fall 10+%, double dose of inhaled CCS – Fall 20+%, use short-acting bronchodilator Q4 -6 hour, plus 2-4 x inhaled CCS – Call office, try to determine if infection is present – Fall 40 - 50%, add oral CCS – Fall greater than 50%, urgent visit to either • Outpatient office • Emergency room Kaliner In: Current Review of Asthma. Current Medicine, 2003 Use of inhaled corticosteroids Copyright permission for reproduction pending Rabe et al. Eur Respir J 2000; www.asthmainamerica.com; Lai et al. J Allergy Clin Immunol 2003; Data on file Preventing exacerbations underlying causes and patient education Evaluate patient for : – Allergy – Infection – Compliance – Inappropriate concomitant medications – Social factors – Tobacco, drugs, irritants, fumes – Psychiatric disorders Initiate or review patient education and selfmanagement plan Role of allergy in managing asthma • • • • 90% of asthmatics <16 years old are allergic 70% of asthmatics 16-30 are allergic 50% of adult asthmatics are allergic Any asthmatic who wheezes 2 times/week needs an allergy assessment • Allergy avoidance and allergy vaccination are effective treatments for asthma (Evidence A) • Allergy treatment is both cost-effective and is the only treatment capable of reducing asthma long-term The main goal of the 10 year Finnish Asthma Programme: • To lessen the burden of asthma on individuals and society Finnish Asthma Programme: Measures to achieve the goals • Early diagnosis and active treatment • Guided self-management as the primary form of treatment • Reduction in respiratory irritants such as smoking and environmental tobacco smoke • Implementation of patient education and rehabilitation combined with normal treatment, planned individually and timed appropriately • Increase in knowledge about asthma in key groups; and promotion of scientific research • Appointment of one doctor, one nurse and one pharmacist responsible for asthma care in each clinic/region Healthcare benefits from asthma intervention Asthma Indices (base 100 in 1981) 350 300 Reimbursement asthma Hospitalization days Death rate 250 200 150 100 50 0 1981 1983 1985 1987 1989 Year Haahtela et al, Thorax 1998 1991 1993 1995 Healthcare benefits from asthma intervention Finnish Asthma Programme (1994-2004) 60 % change 1993-2003 40 20 0 -20 -40 -60 -80 Haahtela et al, Thorax 2006 asthma prevalence hospital disability days pension total costs cost per pt per year Summary • Asthma management in 2007 is focused on control of the individual patient’s asthma symptoms, a paradigm shift from earlier recommendations of a step-wise increase in therapy based on asthma severity; • Patient self-management plans play an important role in prevention of exacerbations; • Successful asthma interventions lead to increased medication costs but decreased costs for hospitalization, and decreased death rates; • Allergen exposure is an important contributory factor in exacerbations of IgE-mediated asthma. Section 2: Acute Severe Asthma Severe asthma • A shift in focus from severity to control • How to control severe asthma • Diagnosis and management of acute severe asthma Lecture objectives: Section 2 At the end of this section participants will be able to: • Understand the risk factors for asthma exacerbations • Understand the pathophysiology of acute severe asthma • Identify the signs and symptoms of acute asthma • Outline appropriate treatment strategies for optimal control of acute asthma exacerbations Frequency of hospital and emergency room visits in moderate-severe asthmatics; TENOR study Copyright permission for reproduction pending Rabe et al. Eur Respir J 2000; www.asthmainamerica.com; Lai et al. J Allergy Clin Immunol 2003; Adachi et al. Arerugi 2002; Data on file Acute severe asthma monitoring the cross-road of death Slight Moderate Severe Slight Moderate Severe Normoventilation Hyperventilation Hypoventilation Exhaustion RHONCHI Copyright permission for reproduction pending Eur Respir J 1997; 10: 1359–1371 Bronchial Asthma Spirometric abnormalities Gas exchange abnormalities Central airway narrowing Distal airway narrowing Bronchoconstriction Airway Inflammation Treatments must be directed towards these two components: Smooth muscle spasm Inflammation, edema, plugs Features of a severe asthma exacerbation One or more present: • • • • • • • Use of accessory muscles of respiration Pulsus paradoxicus >25 mm Hg Pulse > 110 BPM Inability to speak sentences Respiratory rate >25 - 30 breaths/min PEFR or FEV1 < 50% predicted SaO2 <91- 92% McFadden Am J Respir Crit Care Med 2003 Risk factors for fatal or near-fatal asthma attacks • • • • • • • • Previous episode of near-fatal asthma Multiple prior ER visits or hospitalizations Poor compliance with medical treatments Adolescents or inner city asthmatics (USA) African-Americans>Hispanics>Caucasians Allergy to Alternaria Recent use of oral corticosteroid (OCS) Inadequate therapy: – Excessive use of β-agonists – No inhaled corticosteroid (ICS) – Concomitant β-blockers Ramirez and Lockey In: Asthma, American College of Physicians, 2002 • • • • • • • • • • Physical findings in severe asthma exacerbations Tachypnea Tachycardia Wheeze Hyperinflation Accessory muscle use Pulsus paradoxicus Diaphoresis (profuse sweating) Cyanosis Sweating Obtundation (altered mental state) Brenner, Tyndall and Crain In: Emergency Asthma. Marcel Dekker 1999 Causes of asthma exacerbations • • • • Lower or upper respiratory infections Cessation or reduction of medication Concomitant medication, e.g. β-blocker Allergen or pollutant exposure Differential diagnosis • COPD • • • • • Bronchitis Bronchiectasis Endobronchial diseases Foreign bodies Extra- or intra-thoracic tracheal obstruction • Carcinoid syndrome Brenner, Tyndall, Crain In: Emergency Asthma. Marcel Dekker, 1999 • Cardiogenic pulmonary edema • Non-cardiogenic pulmonary edema • Pneumonia • Pulmonary emboli • Chemical pneumonitis • Hyperventilation syndrome Acute severe asthma – associations and differential diagnoses • • • • • • • • Hyperventilation syndrome Vocal cord dysfunction Vaso-vagal reaction Anaphylactic reaction (urticaria, BP, pulse rate, etc) Aspiration - foreign body – pneumonia Pneumothorax Cardiac failure Lung emboli Stages of asthma exacerbations Stage 1: Symptoms • Somewhat short of breath • Can lie down and sleep through the night • Cannot perform full physical activities without shortness of breath Signs • Some wheezes on examination • Respiratory rate, 15 (normal <12) • Pulse 100 • Peak flows and spirometry reduced by 10% Stages of asthma exacerbations Stage 2: Symptoms • Less able to do physical activity due to shortness of breath • Dyspnea on walking stairs • May wake up at night short of breath • Uncomfortable on lying down • Some use of accessory muscles of respiration Signs • Wheezing • Respiratory rate 18 • Pulse 111 • Peak flows and spirometry reduced by 20+% Stages of asthma exacerbations Stage 3: Symptoms • Unable to perform physical activity without shortness of breath • Cannot lie down without dyspnea • Speaks in short sentences • Using accessory muscles Signs • Wheezing • Respiratory rate 19 - 20 • Pulse 120 • Peak flows and spirometry reduced by 30+% Stages of asthma exacerbations Stage 4: Symptoms • Sitting bent forward • Unable to ambulate without shortness of breath • Single word sentences • Mentally-oriented and alert • Use of accessory muscles Signs • Wheezing less pronounced than anticipated • Respiratory rate 20 - 25 • Pulse 125+ • Peak flows and spirometry reduced by 40+% • SaO2 91- 92% Stages of asthma exacerbations Stage 5: Symptoms • Reduced consciousness • Dyspnea • Silent chest – no wheezing Signs • Fast, superficial respiration • Respiratory rate >25 • Unable to perform peak flows or spirometry • Pulse 130 - 150+ • SAO2 <90 Severity of asthma as graded by % predicted FEV1 FEV% predicted • 70 - 100 • 60 - 69 • 50 - 59 • 35 - 49 • < 35 Severity Mild Moderate Moderately severe Severe Very severe: (life-threatening) Acute severe asthma - clinical assessment • Respiratory frequency: (count) – Speech: sentences, single words • Auxiliary respiratory muscle use • Posture: sitting, can patient lie down? • Airway patency: rhonchi, silent chest (PEF) • Respiration: cyanosis (SaO2, blood gases) • General appearance, effort of breathing: activity level (pulse rate) Acute severe asthma - monitoring • Clinical condition • PEF or FEV1 • PaO2 and PaCO2 ACUTE ASTHMA – MONITORING CHART Name: Birth date: Date: Time first seen: Time Pulse rate History: Respiratory rate Use of accessory muscles PEF Pulse oximetry (SaO2) Cyanosis Exhaustion Oxygen flow Neck _________ ______ l/m Abdomen Arms Neck _________ ______ l/m Abdomen Arms Neck _________ ______ l/m Abdomen Arms Treatment Short Acting Beta Agonist Dose: ____________ Delivery: Nebuliser/Spacer Oral steroid: ________ Inhaled steroid: ______ Short Acting Beta Agonist Dose: ____________ Delivery: Nebuliser/Spacer Oral steroid: ________ Inhaled steroid: ______ Short Acting Beta Agonist Dose: ____________ Delivery: Nebuliser/Spacer Oral steroid: ________ Inhaled steroid: ______ Acute severe asthma Admission and close monitoring in hospital unit: • Clinical stage 4 • PEF or FEV1 < 30% of personal best (if unknown < 30% predicted) • PaCO2 > 6 kPa • PaO2 < 8 kPa • Poor response to initial treatment Acute severe asthma treatment Oxygen by nasal cannulae or mask Inhaled broncodilator should be administered at regular Intervals (Evidence A): Nebulised ß2-agonist combined with anticholinergic each 20 mins in the first hour, then hourly as necessary Systemic steroid should be utilised in all but the Mildest Exacerbations (Evidence A): Oral (50-75mg prednisolone) or i.v. corticosteroid (80 mg Methylprednisolone); repeat after 12 hours; over the following days 40 mg prednisolone or equivalent is usually maintained Start inhaled high dose steroid as soon as possible Acute severe asthma treatment Dangerous, or at least ineffective Dangerous:Sedation Ineffective: Mucolytics Physiotherapy Antihistamines Acute severe asthma treatment Consider: Infusion of Beta-2-agonist Infusion of theophylline Antibiotics – not all acute asthma exacerbations require antibiotics Fluids Acute severe asthma – treatment options Standard treatment: Oxygen Inhaled beta-2-agonist +/- anticholinergic Systemic corticosteroid Additional options: Systemic beta-2-agonist and/or theophylline, antibiotics, fluids Nonstandard treatment: Antileukotrienes; Magnesium sulphate; Heliox; Bi-pap Extreme intervention: Intubation and controlled hypoventilation/other strategy Anesthesia-sedation; Bronchial lavage Treatment of asthma exacerbations oral corticosteroids • Oral corticosteroids are the most powerful medications available to reduce airway inflammation • Use until attack has completely abated: – PEFR and FEV1 at baseline levels – Symptoms gone • Taper to QOD and determine if patient can remain well if corticosteroids are withdrawn completely Acute severe asthma • Treat the condition symptomatically • Determine what caused the exacerbation: – – – – – inhalant allergen food allergen drug reaction (ASA, vaccination, etc) infection worsening of a chronic condition: - poor therapy compliance - treatment needs adjustment Prevention of relapse and recurrence of asthma exacerbation - definition Relapse: Reappearance of asthma symptoms that require unscheduled care within 3 weeks of an asthma exacerbation Recurrence: Reappearance of asthma symptoms that require unscheduled care more than 3 weeks after the asthma exacerbation Prevention of relapse and recurrence of asthma exacerbation Patients treated for an asthma exacerbation are at risk for subsequent severe attacks: (unscheduled doctor visits, Emergency Department visits, hospitalization, asthma death) Proper asthma care can reduce this risk: a) Pharmacological intervention with ICS b) Patient education – knowledge and skills c) Self management plans and follow up Prospective multicenter study of relapse after ED care of acute severe asthma Relapse rate: 17% Associations OR Multiple previous ED visits for asthma 1.3 Use of home nebulizer Long duration of symptoms Report of multiple triggers (per trigger) 2.2 2.5 1.1 Emerman C et.al. Chest 1999; 115: 919-27 Comparison of short course of Inhaled CS and Oral CS for acute asthma exacerbation in primary care 413 patient in 47 general practices. Treatments: a) oral prednisolone 40mg daily for 16 days b) inhaled FP 1000mcg x 2 daily for16 days Outcome was failure: Defined by symptoms and/or PEF Levy ML et el. Thorax; 1996; 51: 1087-92 Comparison of short courses of OCS vs ICS in the treatment of asthma exacerbation in primary care Copyright permission for reproduction pending Levy ML, et al. Thorax 1996; 51:1087-1092 Viral respiratory infection and asthma exacerbations Studies using PCR techniques have shown that viral infection is a common cause of asthma exacerbations. Age 19-46y 9-11y 6m-12y 2m-16y n 138 108 75 70 Setting Outpatient Outpatient Hospitalized ED %viral 55 85 82 83 Reference _______ Nicholson BMJ 1993 Johnston BMJ 1995 Freymoth JCVirol 1999 Rakes AJRCCM 1999 Antibiotics in asthma exacerbations • Use antibiotics if any suspicion of bacterial infection • If antibiotics are prescribed, recommendation is for broad spectrum macrolide antibiotics that cover atypical bacteria (chlamydia, mycoplasma), eg, azithromycin, clarithromycin, erythromycin, roxithromycin, dirithromycin, amoxicillin + clavulan; moxifloxacin, cefuroxim Delays in seeking help for acute asthma - the patient’s perspective 95 patients explained their reasons for delaying seeking professional care: • • • • • • • Janson S. J Asthma 1998; 35: 427-35 Uncertainty Disruption Minimization ”Self-reliance” Fear of steroids To avoid ED Economic reasons 74% 86% 90% 46% 31% 34% 5% Acute severe asthma IS A RESPIRATORY ATTACK! • Treat, Monitor and Follow-up • Consider improved prophylaxis: - allergen avoidance - allergen vaccination - pharmacological treatment update - stop smoking - enhance compliance to recommendations by teaching and monitoring World Allergy Organization (WAO) For more information on the World Allergy Organization (WAO), please visit www.worldallery.org or contact the: WAO Secretariat 555 East Wells Street, Suite 1100 Milwaukee, WI 53202 United States Tel: +1 414 276 1791 Fax: +1 414 276 3349 Email: [email protected]