– Diagnosis and Management of Asthma – Clinical Practice Guideline
Diagnosis and Management of Asthma – Adult/Pediatric – Clinical Practice Guideline Cover Sheet Target Population: Adults and Pediatrics diagnosed with Asthma Guideline Contact for Content: Name: William Busse, MD Phone Number: 608-263-6183 Email Address: [email protected] Guideline Contact for Document Changes: Name: Tom Mably, PhD Phone Number: 608-890-6695 Email Address: [email protected] Coordinating Team Members/Review Individuals: Tim Ballweg (GHC), Jeremy Bufford, MD (Meriter), William Busse, MD, Jonathan Fliegel, MD (Pediatrics, Hospitalist), Daniel Jackson, MD (Pediatrics), Michael Kim, MD (Pediatrics, Emergency Department), Joshua Ross, MD (Emergency Department) , Robert Lemanske, MD (Pediatrics), Russell Lemmon, MD (Family Medicine), Pamela Olson, MD (Family Medicine), Scott Guetzlaff (CCKM), Kathleen Shanovich, RN, Rhonda Yngsdal-Krenz (Respiratory Therapy), Elaine Rosenblatt , MSN (Unity), Cara Winsand, Jody Jardine, RN (Physician’s Plus), Jennifer Schauer, RPh, PharmD (Unity), Lisa Sherven, RN (GHC), Kim Volberg, RN (Dean Health Care) Committee Approvals/Dates:Clinical Knowledge Management Council / October 24, 2013 Release Date: October 30, 2013 1 Executive Summary Guideline Title: Diagnosis and Management of Asthma - Adult/Pediatric – Clinical Practice Guideline Guideline Overview: The 2013 Asthma guidelines are a condensed version of the 2007 Summary Report of Guidelines for the Diagnosis and Management of Asthma and the 2004 Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment produced by the U.S. Department of Health and Human Services. 2 Practice Recommendations: 3 4 Estimated Comparative Daily Dosages for Inhaled Corticosteroids in Children and Adults (years of age) Drug Beclomethasone HFA 40 or 80 mcg/puff Budesonide DPI 90, 180 or 200 mcg/inhalation Budesonide inhaled Inhalation for suspension Ciclesonide HFA 80 or 160 mcg Flunisolide HFA 80 mcg/puff Fluticasone HFA/MDI: 44, 110, or 220 mcg/puff DPI: 50, 100 or 250 mcg/inhalation Low Daily Dose Child Child Adult (0-4) (5-11) (≥12) Medium Daily Dose Child Child Adult ( 0-4) (5-11) (≥12) High Daily Dose Child Child Adult (0-4) (5-11) (≥12) NA 80-160 mcg 80-240 mcg NA >160-320 mcg >240480 mcg NA >320 mcg >480 mcg NA 180400 mcg 180600 mcg NA >400-800 mcg >6001200 mcg NA > 800 mcg >1200 mcg 0.250.5 mg 0.5 mg NA >0.5-1 mg 1 mg NA >1 mg 2 mg NA NA NA NA NA 320 mcg NA NA NA 160 mcg 160 mcg 320 mcg NA 320 mcg >320640 mcg NA ≥640 mcg 640 mcg >640 mcg 176 mcg 88-176 mcg 88-264 mcg >176352 mcg >176-352 mcg >264440 mcg >352 mcg >352 mcg >440 mcg NA 100200 mcg 100NA >200>300NA >400 >500 300 400mcg 500 mcg mcg mcg mcg Mometasone DPI NA 200 >400 NA NA NA 400 mcg NA NA 200 mcg/inhalation mcg mcg Key: HFA: hydrofluoroalkane; NA, not approved and no data available for this age group * Most important determinant of appropriate dosing is clinician’s judgement of patient’s response to therapy * Some doses may be outside FDA approved dosing, especially in high dose range * Metered dose inhaler (MDI) dosages are expressed as the actuator dose * Safety & efficacy of inhaled corticosteroids in children < 1 yr have not been established;children < 4 yrs of age generally require a face mask for ICS administration 5 Diagnosis and Management of Asthma – Adult/Pediatric Clinical Practice Guideline Table of Contents Introduction………………………………………………………………………………....7 Diagnosis and Management Flowchart………………………………………………. .8 Diagnosis and Management Summary………………………………………………...9 Stepwise Management Summary……………………………………………………...10 Practice Recommendations ……………………………………………………………11 1. Diagnosis/ Assessment of Severity…………………………………..………11 2. Medications………………………………………………………………………..13 3. Patient Education……………………………………………………………...…16 4. Exacerbations …………………………………………………………...……….17 5. Special Situations (Exercise-Induced Bronchospasm & Pregnancy).….18 6. Asthma Specialist Consultation……………………………………………….19 Additional Provider Resources………………………………………………………...23 Evidence/References…………………………………………………………………….31 Acknowledgements………………………………………………………………………32 6 INTRODUCTION Guidelines are designed to assist clinicians by providing a framework for the evaluation and treatment of patients. These guidelines outline the preferred approach for most patients. They are not intended to replace a clinician's judgment or to establish a protocol for all patients. It is understood that some patients will not fit the clinical condition contemplated by a guideline and that a guideline will rarely establish the only appropriate approach to a problem. The guidelines below are adapted from the National Asthma Education and Prevention Program. (2007). Guidelines for the Diagnosis and Management of Asthma (Summary Report). U.S. Department of Health and Human Services, Expert Panel 3, 1-60. What is Asthma: Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role: in particular, mast cells, eosinophils, neutrophils (especially in sudden onset, fatal exacerbations, occupational asthma, and patients who smoke), Tlymphocytes, macrophages, and epithelial cells. In susceptible individuals, this inflammation causes recurrent episodes of coughing (particularly at night or early in the morning), wheezing, breathlessness, and chest tightness. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment. The goals of asthma therapy are to prevent chronic asthma symptoms and asthma exacerbations, maintain normal activity levels, have normal or near normal lung function, experience no or minimal side effects and have patient satisfaction with asthma care. 7 DIAGNOSIS AND MANAGEMENT FLOWCHART Diagnosis and Management of Asthma Patient presents with symptoms of asthma Establish diagnosis of asthma and determine level of severity no Previous diagnosis of asthma? yes Acute asthma exacerbation? yes Assess severity of asthma exacerbation Does patient need ED or inpatient management? no yes Send to ED no Evaluation: Medical history Use of validated questionnaire Assess asthma triggers Physical examination Measure lung function Consider consultation and/or allergy testing Management of asthma exacerbation Beta2-agonists Corticosteroids Assess response to treatment yes Determine level of asthma control Step care of pharmacologic treatment Asthma Education Basic facts about asthma How medications work Inhaler technique Written action plan based on home peak flow rate Environmental control measures Emphasize need for regular follow-up visits Does patient need ED or inpatient asthma management? no Schedule regular follow-up visits to assess control and potentially step-up or step-down care. 8 9 10 PRACTICE RECOMMENDATIONS Diagnosis/Assessment of Asthma The presence of multiple key indicators increase the probability of asthma. Wheezing o High-pitched whistling sounds when breathing out—especially in children. o A lack of wheezing and a normal chest examination do not exclude asthma. History of any of the following: o Cough (worse particularly at night) o Recurrent wheeze o Recurrent difficulty in breathing o Recurrent chest tightness Symptoms occur or worsen in the presence of: o Exercise o Respiratory infection o Allergens (e.g., animals with fur or hair, house-dust mites, mold, pollen, foods) o Irritants (e.g. tobacco or wood smoke, airborne chemicals, perfumes, scents) o Changes in weather o Emotions (e.g. laughing, crying, stress) o Hormonal changes o Co-morbidities such as gastroesophogeal reflux disease (GERD) Symptoms occur or worsen at night, awakening the patient. Recommended Methods to Establish the Diagnosis Detailed medical history. “Suggested Items for Medical History” For questions to include See figure 1in Additional Provider Resources Physical examination may reveal findings that increase the probability of asthma, but the absence of these findings does not rule out asthma because the disease is variable and signs may be absent between episodes. The examination focuses on: o Upper respiratory tract (increased nasal secretion, mucosal swelling and or/nasal polyp) o Chest (sounds of wheezing during normal breathing or prolonged phase of forced exhalation, hyperexpansion of the thorax, use of accessory muscles, appearance of hunched shoulders, chest deformity) o Skin (atopic dermatitis, eczema) Spirometry may demonstrate obstruction and assesses reversibility in patients ≥ 5 years of age. Patients’ perceptions of their airflow obstruction are highly variable. Spirometry may be ordered in clinic or hospital-based pulmonary function lab. Consider referral to an asthma specialist if patient is on a moderate to high dose of Inhaled Corticosteroids (ICS), has uncontrolled asthma, or has co-morbid conditions Assessing Severity for Treatment Initiation/Assessing Control for Treatment Monitoring and Modification Severity: Intensity of the disease; combination of impairment and risk to establish level of severity. (To assess severity refer to figures 3 and 6) Impairment: Frequency and intensity of symptoms and functional limitations the patient is currently experiencing or has recently experienced. Risk: The likelihood of either asthma exacerbations (acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combinations of these symptoms), progressive decline in lung function (or for children, reduced lung growth), or risk of adverse effects from medication. Control: The degree to which the manifestations of asthma are minimized by therapeutic intervention and the goals of therapy are met; similar to severity, combination of impairment 11 and risk guide level of asthma control. (To assess control refer to figures 4 and 7; for stepwise approach to therapy modification refer to figures 5 and 8) o Validated control questionnaires are available. Asthma Control Test (ACT) A questionnaire may help determine if asthma is under control and that the treatment plan is effective or alteration in medication should be considered at each opportunity A patient diagnosed with asthma should take the ACT with their primary care physician clinic (or asthma specialist) once a year. To take an ACT test: http://www.asthmacontrol.com/index.html (adult ages >12) http://www.asthma.com/resources/child-asthma-control-test.html (pediatric ages 4-11) http://asthmatracktest.com/ (for children <5 years) Once therapy is initiated, the emphasis thereafter for clinical management is changed to the assessment of asthma control. The level of asthma control will guide decisions either to maintain or adjust therapy. Responsiveness: The ease with which asthma control is achieved by therapy. Follow-up Visits: The frequency of monitoring is a matter of clinical judgment. In general, visits should be scheduled: o 2- to 6- week intervals for patients who are just starting therapy or who require a step up in therapy to achieve or regain asthma control. o 1- to 6- month intervals after asthma control is achieved to monitor whether asthma control is maintained. The interval will depend on factors such as the duration of asthma control or the level of treatment required. o Consider scheduling visits at 3-month intervals if a step down in therapy is anticipated. 12 2. Medications (Ask patients about all medications and interventions they are using) Medications for Asthma Management Examples Quick-Relief Medication or Long-Term Inhaled Corticosteroids (ICS) Beclomethasone, Budesonid Long-term Leukotriene Modifiers Montelucast Long-term Long Acting Beta Agonists (LABAs) Salmeterol, formoterol Long-term Combination products Long-term Immunomodulators Omalizumab (antiIgE) Long-term Methylxanthines Theoophylline Long-term Mast Cell Stabilizers Chromolyn Sodium Short Acting Beta Agonists (SABAs) Albuterol, levalbuterol, and pirbuterol Ipatropion Quick-relief Methylprednisolonge Quick-relief Anticholinergics Systemic Corticosteriods Complementary and Alternative Medications (CAMS) Quick-relief Complementary and Alternative Medications (CAMS) Purpose Reduce airway hyperresponsiveness, inhibit inflammatory cell migration and activation and block late phase reaction to allergen. Interfere with the pathway of leukotriene mediators, which are released from mast cells, eosinophils, and basophils. Bronchodilation of at least 12 hours after a single dose. LABA & ICS for moderate persistent asthma. Prevents binding of IgE to the high-affinity receptors on basophils and mast cells. Mild to moderate bronchodilator used as alternative therapy for mild persistent asthma or as adjunctive therapy with ICS in patients ≥5 years of age. Stabilize mast cells and interfere with chloride channel function. Bronchodilators that relax smooth muscle. Inhibit muscarinic cholinergic receptors and reduce intrinsic vagal tone of the airway. Used for severe exacerbations in addition to SABAs to speed recovery and to prevent recurrence of exacerbations. Evidence is insufficient to recommend or not recommend most CAMS or treatments for asthma. Considerations They are the preferred controller medication for all age groups. Metered dose inhalers (MDIs) may be used with a spacer. They must be used in combination with an ICS. Step 3 care or above. Not preferred therapy. Cromolyn Sodium available only in nebulized form. Not preferred therapy May be used as an alternative to SABAs in patients who cannot tolerate SABAs. Patients who use herbal treatments for asthma should be cautioned about potential drug interactions and harmful ingredients 13 3. Estimated Comparative Daily Dosages for Inhaled Corticosteroids in Adults and Children (years of age) Drug Beclomethasone HFA 40 or 80 mcg/puff Budesonide DPI 90, 180 or 200 mcg/inhalation Budesonide inhaled Inhalation for suspension Ciclesonide HFA 80 or 160 mcg Flunisolide HFA 80 mcg/puff Fluticasone HFA/MDI: 44, 110, or 220 mcg/puff DPI: 50, 100 or 250 mcg/inhalation Low Daily Dose Child Child Adult (0-4) (5-11) (≥ 12) Medium Daily Dose Child Child 5Adult ( 0-4) (5-11) (≥ 12) High Daily Dose Child Child Adult (0-4) (5-11) (≥ 12) NA 80-160 mcg 80-240 mcg NA >160-320 mcg >240480 mcg NA >320 mcg >480 mcg NA 180400 mcg 180600 mcg NA >400-800 mcg >6001200 mcg NA > 800 mcg >1200 mcg 0.250.5 mg 0.5 mg NA >0.5-1 mg 1 mg NA >1 mg 2 mg NA NA NA NA NA 320 mcg NA NA NA 160 mcg 160 mcg 320 mcg NA 320 mcg >320640 mcg NA ≥640 mcg 640 mcg >640 mcg 176 mcg 88-176 mcg 88-264 mcg >176352 mcg >176-352 mcg >264440 mcg >352 mcg >352 mcg >440 mcg NA 100200 mcg 100NA >200>300NA >400 >500 300 400mcg 500 mcg mcg mcg mcg Mometasone DPI NA 200 >400 NA NA NA 400 mcg NA NA 200 mcg/inhalation mcg mcg Key: HFA: hydrofluoroalkane; NA, not approved and no data available for this age group * Most important determinant of appropriate dosing is clinician’s judgement of patient’s response to therapy * Some doses may be outside FDA approved dosing, especially in high dose range * Metered dose inhaler (MDI) dosages are expressed as the actuator dose * Safety & efficacy of inhaled corticosteroids in children < 1 yr have not been established;children < 4 yrs of age generally require a face mask for ICS administration 14 4. Asthma Medication by Catogory Drug (Generic name) Drug (Brand name) Albuterol Albuterol Albuterol Albuterol Bronchodilators Proair HFA Proventil HFA Ventolin HFA Albuterol Nebs (0.083%, 25) 0.63 mg/mL; 1.25 mg/3 mL; 2.5 mg/3mL, 2.5 mg/0.5 mL Albuterol Albuterol/I pratropium Albuterol/I pratropium Formoterol Formoterol Ipratropium Levalbuterol Levalbuterol Pirbuterol Salmeterol Tiotropium Beclomethasone Beclomethasone Budesonide Budesonide Budesonide Budesonide Budesonide Ciclesonide Ciclesonide Flunisolide Fluticasone Fluticasone Fluticasone Fluticasone Fluticasone Fluticasone Mometasone Mometasone Budesonide/formoterol Budesonide/formoterol Fluticasone/salmeterol Fluticasone/salmeterol Fluticasone/salmeterol Fluticasone/salmeterol Fluticasone/salmeterol Fluticasone/salmeterol Mometasone/formoterol Montelukast Montelukast Montelukast Montelukast Zafirlukast Zafirlukast Zileuton Zileuton Albuterol Syrup 2mg/5ml Combivent Respimat* albuterol/ipratropium nebs 0.5 mg/3 mg/3 mL Foradil 12mcg/cap Perforomist 20mcg/2ml nebs ipratropium nebs Xopenex HFA Xopenex nebules 0.31mg/3ml; 0.63mg/3mls; 1.25mg/3ml; 1.25 mg/0.5 mL Maxair* Serevent Spiriva Inhaled CS Qvar 40mcg Qvar 80mcg Pulmicort Flexhaler 90mcg Pulmicort Flexhaler 180mcg budesonide nebs 250mcg Budesonide nebs 500mcg Pulimicort Respules 1mg Alvesco HFA 80mcg Alvesco HFA 160mcg Aerospan 80 mcg Flovent HFA 44mcg Flovent HFA 110mcg Flovent HFA 220mcg Flovent Diskus 50mcg Flovent Diskus 100mcg Flovent Diskus 250mcg Asmanex 110mcg Asmanex 220mcg Inhaled CSS/LBA Symbicort HFA 80/4.5 Symbicort HFA 160/4.5 Advair HFA 45/21 Advair HFA 115/21 Advair HFA 230/21 Advair Diskus 100/50 Advair Diskus 250/50 Advair Diskus 500/50 Dulera 100/5 LTRA's 4 mg granules 4mg chew tab 5mg chew tab 10mg 10mg 20 mg Zyflo 600 mg Zyflo CR 600mg Number of puffs/doses Counter Years after FDA Approval 200 200 60, 200 25 Yes Yes Yes NA 480ml 200 60 NA Yes NA 4 yrs 4 yrs 4 yrs 2 yrs for 0.083%; 12 yrs 0.5%; 2-12 yrs 0.63 mg/3 mL & 1.25 mg/3 mL 2 years Adults Adults 60 caps 60 vials 25 80, 200 24 NA NA NA Yes? NA 5 yrs Adults 12 yrs 4 yrs 6 yrs 400 60 5, 30 & 90 caps No Yes NA 12 yrs 4 yrs Adults 100, 120 100, 120 60 120 15 15 30 60 60 60, 120 120 120 120 60 60 60 30 30, 60, 90 No No Yes Yes na na na Yes Yes 5 yrs 5 yrs 6 yrs 6 yrs 12 months-8 yrs 12 months-8 yrs 12 months-8 yrs 12 yrs 12 yrs Yes Yes Yes Yes Yes Yes Yes Yes 4 yrs 4 yrs 4 yrs 4 yrs 4 yrs 4 yrs 4 yrs 4 yrs 120 120 120 120 120 60 60 60 120 Yes Yes Yes Yes Yes Yes Yes Yes Yes 12 yrs 12 yrs 12 yrs 12 yrs 12 yrs 4 yrs 4 yrs 4yrs 12 yrs 30 30 30 30 60 60 120 120 6 mo-23 months 2 yrs-5 yrs 6 yrs-14 yrs 15 yrs 5 yrs-11 yrs 12 yrs 12 yrs 12 yrs 15 Drug (Generic name) Drug (Brand name) Number of puffs/doses Counter Years after FDA Approval 0.5, 1, 2.5, 5, 10, 20, and 50 mg 5 mg/5mL,5 mg/ml NA ND NA ND NA NA NA ND ND ND NA ND NA NA ND ND NA ND NA NA ND ND NA ND Oral CS Pridnisolone Tablets - Solution - Prednisolone Tablets Oral disintegrating tablets Solution - Methylprednisolone Dose-pak - Tablets - Dexamethasone Tablets - Solution - 4. 5 mg 10, 15, and 30 mg 5 mg/5mL, 15 mg/5mL, 10 mg/5mL, 6.7 mg/5mL, 25 mg/5mL, 20 mg/5mL 21 x 4mg tablets 2, 4, 8, and 16 mg 0.5, 0.75, 1.5, 2, 4, 6, and 8 mg 0.5mg/mL Patient Education for a Partnership in Care Role of Medications: Understanding the Difference o Long-term control medications: prevent symptoms by reducing inflammation. Must be taken daily. Do not give quick relief. o Quick-relief medications: short acting beta agonists (SABA) relax airway muscles to provide prompt relief of symptoms. Do not expect them to provide long-term asthma control. Using SABA >2 days a week indicates the need for starting or stepping up longterm control medications.. o Patient Skills o Taking medications correctly and consistently . Inhaler technique (demonstrate to the patient and have the patient return the demonstration). Use of devices as prescribed (e.g. valved holding chamber (VHC) or spacer, nebulizer). o Identifying and avoiding environmental exposures that worsen the patient’s asthma; e.g., allergens, irritants, tobacco smoke. o Self-monitoring Assess level of asthma control. Monitor symptoms and, if prescribed, peak expiratory flow (PEF) measures. Recognize early signs and symptoms of worsening asthma. o Using a written asthma action plan (refer to figure 2) to know when and how to: Take daily actions to control asthma. Adjust medication in response to signs of worsening asthma. Electronic asthma action plans are located on Health Link o Seeking medical care when appropriate. Additional education materials are available at the following website: o http://www.uwhealth.org/healthfacts/B_EXTRANET_HEALTH_INFORMATIONFlexGroup-Show_Public_HFFY_Category_1103038147775.html 16 Patient education (verbal & written) should occur at all patient points of care (clinic & hospital visits, pharmacy pick-up, etc). Control of Environment Factors and Comorbid Conditions That Affect Asthma Environmental Allergens and Irritants--Identify allergens and pollutants or other irritant exposures. The most troublesome allergen for both children and adults are those that are inhaled. o Advise patients to reduce exposure to allergens and pollutants or irritants which are triggers for their asthma. o Consider subcutaneous allergen immunotherapy for patients who have persistent asthma when there is clear evidence of a relationship between symptoms and exposure to an allergen to which the patient is sensitive. o Administer inactivated influenza vaccination for patients ages 6 months and older who have asthma. Comorbid—Identify and treat comorbid conditions that may impede asthma management. o Allergic Bronchopulmonary Aspergillosis (ABPA) o Gastroesophageal Reflux (GERD) o Obese or overweight patients may be advised that weight loss may help control asthma. o Obstructive Sleep Apnea (OSA) may be considered in patients who don’t have well controlled asthma, particularly ones who are overweight. o Rhinitis or sinusitis should be evaluated in patients who have asthma, because the interrelationship of the upper and lower airway suggests that therapy for the upper airway will improve asthma control. o Stress and depression should be considered in patients who have asthma that is not well controlled. Additional education to improve self-management and coping skills may be helpful. Managing Asthma Exacerbations: Asthma exacerbations are acute or subacute episodes of progressively worsening shortness of breath, cough, wheezing, and chest tightness, or some combinations of these symptoms. Classifying Severity o Severe exacerbation can be life threatening and can occur in patients at any level of asthma severity. o Patients at high risk of asthma-related death require special attention—particularly intensive education, monitoring, and care. Such patients should be advised to seek medical care early during an exacerbation. Risk factors for asthma –related death include: Previous severe exacerbations Two or more hospitalizations or ›3 visits in past year Use of ›2 canisters of SABA per month Difficulty perceiving airway obstruction or the severity of worsening asthma Illicit drug use Major psychosocial problems or psychiatric disease Co morbidities, such as cardiovascular disease or other chronic lung disease 17 Home Management o Early treatment by the patient at home is the preferred strategy for managing asthma exacerbations. o Patients should be instructed how to: Use a written asthma action plan that notes when and how to treat signs of an exacerbation. Recognize early indicators of an exacerbation. Adjust their medications. Remove or withdraw allergens or irritants. Monitor response to treatment and promptly communicate with the clinician about any serious deterioration in symptoms or PEF or about decreased responsiveness to SABA treatment, including decreased duration of effect. o Severe exacerbations should be treated with oral corticosteroids. Management in the Urgent or Emergency Care and Hospital Setting o Administer supplemental oxygen to correct significant hypoxemia in moderate or severe exacerbations. o Administer repetitive or continuous administration of SABA to reverse airflow obstruction rapidly. o Administer systemic corticosteroids to decrease airway inflammation in moderate or severe exacerbations or for patients who fail to respond promptly and completely to SABA treatment. o Monitor response to therapy with serial assessments. 5. Special Situations Exercise-Induced Bronchospasm (EIB) EIB should be anticipated in all asthma patients. A history of cough, shortness of breath, chest pain or tightness, wheezing, or endurance problems during exercise suggests EIB. Long-term control therapy o Initiate or step up long-term control medications Pretreatment before exercise o Inhaled beta2-agonists will prevent EIB for more than 80 % of patients. SABA used approximately 5-15 minutes prior to exercise may be helpful for 2-3 hours. LABA can be protective up to 12 hours, but should not be used without an ICS. o Leukotriene receptor antagonists (LTRAs), with an onset of action generally hours after administration, can attenuate EIB in up to 50% of patients. o A warm-up period before exercise may reduce the degree of EIB. o A mask or scarf over the mouth may attenuate cold-induced EIB Managing Asthma During Pregnancy General Principles: o It is safer for pregnant women with asthma to be treated with asthma medications than for them to have asthma symptoms and exacerbations and risk of fetal hypoxia. o Proper control of asthma should enable a woman with asthma to maintain a normal pregnancy with little or no risk to her or her fetus. o The greatest amount of safety data to support budesonide. However, one can stay on their current ICS. Step 1: Intermittent Asthma o Albuterol is the preferred SABA because it has an excellent proven safety profile during pregnancy. Step 2: Mild Persistent Asthma o Budesonide is the preferred ICS because more supportive data are available on using budesonide in pregnant women than are available on other ICS. 18 Leukotriene modifiers are an alternative but not preferred treatment for pregnant women whose asthma was successfully controlled with this medication prior to their pregnancy. Step 3: Moderate Persistent Asthma (two preferred treatment options) o Combination of low-dose ICS and a LABA. o Increasing the dose of ICS to the medium dose range. Step 4: Severe Persistent Asthma o Refer to an asthma specialist. o If additional medication is required after adherence with step 3 was assessed, then the corticosteroid dose should be increased within the high-dose range, and use of budesonide is preferred. o If this is insufficient, then the addition of systemic corticosteroids is warranted; although data are uncertain about some risks of oral corticosteroids during pregnancy, severe uncontrolled asthma poses a definite risk to the mother and fetus. o 6. Asthma Specialist Consultation Indications for asthma specialist consultation include: Asthma is unresponsive to therapy. Asthma is not well controlled within 3-6 months of treatment. Life-threatening asthma exacerbation. Hospitalization for asthma. Required >2 bursts of oral corticosteroids in 1 year. Requires higher level step care. Immunotherapy is being considered. 19 20 Stepwise Approach for Managing Asthma During Pregnancy and Lactation: Treatment Classify Severity: Clinical Features Before Treatment or Adequate Control Symptoms/Day Symptoms/Night PEF or FEV1 PEF Variability ≤60% >30% Alternative treatment: high-dose inhaled corticosteroid* AND sustained release theophylline to serum concentration of 5-12 mcg/mL. Step 3—Moderate Persistent Daily >1 night/week Daily medications. Preferred treatment: high-dose inhaled corticosteroid AND long-acting inhaled beta2-agonist AND, if needed, corticosteroids tablets or syrup long-term (2 mg/kg per day, generally not to exceed 60 mg per day). (Make repeat attempts to reduce systemic corticosteroid and maintain control with high-dose inhaled corticosteroid.*) Step 4—Severe Persistent Continual Frequent Medications required to maintain long-term control. >60%-<80% >30% Step 2—Mild Persistent Preferred treatment: Either low-dose inhaled corticosteroids* and long-acting inhaled beta2-agonist OR Medium-dose inhaled corticosteroids. If needed (particularly in patients with recurring severe exacerbations), medium-dose inhaled corticosteroid* and long-acting inhaled beta2-agonist. Preferred treatment: Low-dose inhaled corticosteroid.* >2days/week, but <daily ≥80% >2 nights/month 20%-30% Alternative treatment (listed alphabetically): cromolyn, leukotriene receptor antagonist+ OR Sustained-release theophylline to serum concentration of 5-12 mcg/mL. Step 1—Intermittent No daily medication needed ≤2 days/weeks ≤2 nights/month Severe exacerbations may occur, separated by long periods of normal lung function and no symptoms. A course of systemic corticosteroid is recommended. ≥80% <20% Quick Relief—All Patients Short-acting bronchodilator: 2-4 puffs short-acting inhaled beta2- agonist.± as needed for symptoms. Intensity of treatment will depend on severity of exacerbation; up to 3 treatments at 20-minute intervals or a single nebulizer treatment as needed. Course of systemic corticosteroid may be needed. Use of short-acting inhaled beta2- agonist± >2 times a week in intermittent asthma (daily, or increasing use in persistent asthma) may indicate the need to initiate (increase) long-term control therapy. Step Down Review treatment every 1-6 months; a gradual stepwise reduction in treatment may be possible. Step Up If control is not maintained, consider step up. First, review patient medication administration technique, adherence, and environmental control. Goals of Therapy: Asthma Control Minimal or no chronic symptoms day or night. Minimal or no exacerbations. No limitations on activities; no school/work missed. Maintain (near) normal pulmonary function. Minimal use of short-acting inhaled beta2- agonist.± Minimal or no adverse effects from medications. Notes: Classify severity: assign patient to most severe step in which any feature occurs (PEF is percent of personal best; FEV 1 is percent predicted). Gain control as quickly as possible (consider a short course of systematic corticosteroid), then step down to the least medication necessary to maintain control. Minimize use of short-acting inhaled beta2-agonist ± (e.g., use of approximately one canister a month even if not using it every day indicates inadequate control of asthma and the need to initiate or intensify long-term control therapy). Provide education on self-management and controlling environmental factors that make asthma worse (e.g., allergens, irritants). Refer to an asthma specialist if there are difficulties controlling asthma or if step 4 care is required. Referral may be considered if step 3 care is required. * There are more data on using budesonide during pregnancy than on using other inhaled corticosteroids. + There are minimal data on using leukotriene receptor antagonists in humans during pregnancy, although there are reassuring animal data submitted to FDA. ± There are more data on using albuterol during pregnancy than on using other short-acting inhaled beta2-agonists. 21 Management of Asthma Exacerbation During Pregnancy and Lactation Assess Severity Measure PEF: Value <50% personal best of predicted suggests severe exacerbation Note signs and symptoms: Degrees of cough, breathlessness, wheeze, and chest tightness correlate imperfectly with severity of exacerbation Accessory muscle use and suprasternal retractions suggest severe exacerbation Note presence of fetal activity* Initial Treatment Short-acting inhaled beta2-agonist: up to 3 treatments of 2-4 puffs by MDI at 20-minute intervals or single nebulizer treatment Poor Response Good Response Incomplete Response Mild Exacerbation: PEF >80% predicted or personal best No wheezing or shortness of breath Moderate exacerbation: PEF50%-80% predicted to personal best Response to short-acting inhaled beta2-agonist sustained for 4 hours Persistent wheezing and shortness of breath Appropriate fetal activity* _____________________________ Decreased fetal activity* ___________________________ Treatment: May continue short-acting inhaled beta2-agonist every 3-4 hours for 24-48 hours. Treatment: Add oral corticosteroid Continue short-acting inhaled beta2-agonist For patients on inhaled corticosteroid, consider 3-4 times their usual dose for 7-10 days Patient should contact clinician for follow-up instructions Patient should contact clinician urgently Severe Exacerbation: PEF <50% predicted or personal best Marked wheezing and shortness of breath Decreased fetal activity* ___________________________ Treatment: Add oral corticosteroids Repeat short-acting inhaled beta2agonist immediately If distress is severe and nonresponsive, patient should call clinician immediately and proceed to emergency department: consider calling ambulance or 911 Patient should proceed to emergency department MDI=Metered-dose inhaler PEF=Peak expiratory flow *Fetal activity is monitored by observing whether fetal kick counts decreased over time 22 ADDITIONAL PROVIDER RESOURCES Figure 1: Suggested Items for Medical History Suggested Items for Medical History* A detailed medical history of the new patient who is known or thought to have asthma should address the following items 1. Symptoms · Cough · Wheezing · Shortness of breath · Chest tightness · Sputum production 5. Family history · History of asthma, allergy, sinusitis, rhinitis, eczema, or nasal polyps in close relatives 6. Social history · Daycare, workplace, and school characteristics that may interfere with adherence · Social factors that interfere adherence, such as substance abuse 2. Pattern of symptoms · Social support/social networks · Perennial, seasonal, or both · Level of education completed · Continual, episodic, or both Employment · Onset, duration, frequency (number of days or nights, per week · or month) 7. History of exacerbations · Diurnal variations, especially nocturnal and on awakening in · Usual prodromal signs and symptoms early morning · Rapid onset · Duration 3. Precipitating and/or aggravating factors · Frequency · Viral respiratory infections · Severity (need for urgent care, hospitalization, intensive care unit · Environmental allergens, indoor (e.g., mold, house-dust mite, (ICU) admission) cockroach, animal dander or secretory products) and outdoor · Life-threatening exacerbations in the past year (e.g., pollen) · Usual patterns and management (what works?) · Characteristics of home including age, location, cooling and · · · · · · · · · · · · heating system, wood burning stove, humidifier, carpeting over concrete, presence of molds or mildew, presence of pets with fur 8. Impact of asthma on patient and family Episodes of unscheduled care (emergency department (ED), or hair, characteristics of rooms where patient spends time (e.g., · urgent care, hospitalization) bedroom and living room with attention to bedding, floor · Number of days missed from work/school covering, stuffed furniture) · Limitation of activity, especially sports and strenuous work Smoking (patient and others in home or daycare) · History of nocturnal awakening Exercise · Effect of growth, development, behavior, school or work Occupational chemicals or allergens performance and lifestyle Environmental change (e.g., moving to new home, going on · Impact on family routines, activities, or dynamics vacation, and/or alterations in workplace, work processes or · Economic impact materials used) Irritants (e.g., tobacco smoke, strong odors, air pollutants, occupational chemicals, dusts and particulates, vapors, gases and aerosols) Emotions (e.g., fear, anger, frustration, hard crying or laughing) Stress (e.g., fear, anger, frustration) Drugs (e.g., aspirin and other nonsteroidal anti-inflammatory drugs, beta-blockers, including eye drops, others) Food, food additives, and preservatives (e.g., sulfites) Changes in weather, exposure to cold air Endocrine factors (e.g., menses, pregnancy, thyroid disease) Comorbid conditions (e.g. sinusitis, rhinitis, gastroesphogeal reflux disease (GERD)) 9. Assessment of patient’s and family’s perceptions of disease · Patient’s parent’s and spouse's/ partner’s knowledge of asthma and belief in the chronicity of asthma and in the efficacy of treatment · Patient’s perception and beliefs regarding use and long-term effects of medications · Ability of patient and parents, spouse or partner to cope with disease · Level of family support and patient’s and parent’s, spouse’s or partner’s capacity to recognize severity · Economic resources · Sociocultural beliefs 4. Development of disease and treatment · Age of onset and diagnosis · History of early-life injury to airways (e.g., bronchopulmonary dysplasia, pneumonia, parental smoking) · Progression of disease (better or worse) · Present management and response, including plans for managing exacerbations · Frequency of using short-acting beta2-agonist (SABA) · Need for oral corticosteroids and frequency of use * This list does not represent a standardized assessment or diagnostic instrument. The validity and reliability of this list have not been assessed. 23 Figure 2: Asthma Action Plan 24 Figure 3: Classifying Asthma Severity and Initiating Therapy in Children Classifying Asthma Severity and Initiating Therapy in Children Persistent Components of Severity Intermittent Ages 0-4 Ages 5-11 ≤2 days/week Symptoms Nighttime Awakenings Impairment Mild 0 Short-acting beta2-agonist use for symptom control Interference with normal activity Lung function o FEV1 (predicted) or peak flow (personal best FEV1/FVC) N/A ≤2x/month Ages 5-11 3-4x/month >1x/week but not nightly Throughout the day >1x/week Often 7x/week Daily Several times per day None Minor limitation Some limitation Extremely limited Normal FEV1 between exacerbations >80 % Step 1 (for both age groups) (See “Stepwise Approach for Managing Asthma” for treatment steps) 3-4x/month Ages 5-11 >2 days/week but not daily 0-1/year (see notes) Recommended step for initiation therapy Ages 0-4 ≤2 days/week >80 % N/A N/A >80 % Exacerbations requiring oral systemic corticosteroids (consider severity and interval since last exacerbation) Ages 5-11 Daily >85% Risk Ages 0-4 >2 days/week but not daily 1-2x/month Severe Moderate Ages 0-4 60%-80% 75%-80% N/A <60% <75% ≥2 exacerbations in ≥2x/year (see 6 months requiring notes) oral systemic corticosteroids, or Relative ≥4 wheezing annual risk episodes/1 year may be lasting >1 day AND related to risk factors for FEV1 persistent asthma Step 2 (for both age groups) Step 3 and consider Step 3: medium-dose short ICS option and course of consider short course oral of oral systemic systemic corticosteroids corticoste roids Step 3 and consider Step 3: medium-dose short ICS option OR step 4 course of and consider short oral course of oral systemic systemic corticosteroids corticost eroids In 2-6 weeks, depending on severity, evaluate level of asthma control that is achieved. o Children 0-4 years old: if no clear benefit is observed in 4-6 weeks, stop treatment and consider alternative diagnosis or adjusting therapy. o Children 5-11 years old: adjust therapy accordingly. Key: FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroids; ICU, intensive care unit; N/A, not applicable Notes: -- Level of severity is determined by both impairment and risk. Assess impairment domain by caregiver’s recall of previous 2–4 weeks. Assign severity to the most severe category in which any feature occurs. --Frequency and severity of exacerbations may fluctuate over time for patients in any severity category. At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. In general, more frequent and severe exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity. For treatment purposes, patients with ≥2 exacerbations described above may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma. 25 Figure 4: Assessing Asthma Control and Adjusting Therapy in Children Assessing Asthma Control and Adjusting Therapy in Children Components of Control Well Controlled Ages 0-4 Symptoms ≤2 days/week, but not more than once on each day ≤1x/month Nighttime Awakenings Impairment Short-acting beta2-agonist use for symptom control (not prevention of EIB) Interference with normal activity Lung function o FEV1 (predicted) or peak flow (personal best) o FEV1/FVC N/A N/A o (See “Stepwise Approach for Managing Asthma” for treatment steps) Ages 5-11 Ages 0-4 ≥2 days/week or multiple times on ≤2 days/week >1x/month Ages 5-11 Throughout the day ≥2x/week >1x/week ≥2x/month >2 days/week Several times per day None Some limitation Extremely limited >80 % N/A Requires long-term follow-up 60-80% <60% N/A <75% 75-80% 2-3x/year ≥2x/year >3x/year N/A ≥2x/year N/A Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control, but should be considered in the overall assessment of risk. o o Recommended action for treatment Very Poorly Controlled ≤2 days/week 0-1x/year Reduction in lung growth Treatment-related adverse effects Ages 0-4 >80% Exacerbations requiring oral systemic corticosteroids Risk Ages 5-11 Not Well Controlled Maintain current step Regular follow-up every 1-6 months Consider step down if well controlled for at least 3 months. Step up 1 step Step up at least 1 step o o Consider short course of oral systemic corticosteroids Step up 1-2 steps Before step up: o Review adherence to medication, inhaler technique, and environmental control. o If alternative treatment was used, discontinue it and use preferred treatment for that step. Reevaluate the level of asthma control in 2-6 weeks to achieve control; every 1-6 months to maintain control. Children 0-4 years old: if no clear benefit is observed in 4-6 weeks, consider alternative diagnoses or adjusting therapy. Children 5-11 years old: adjust therapy accordingly For side effects, consider alternative treatment options. Key: EIB, exercise-induced bronchospasm, FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICU, intensive care unit; N/A, not applicable Notes: --The level of control is based on the most severe impairment or risk category. Assess impairment domain by patient’s or caregiver’s recall of previous 2–4 weeks. Symptom assessment for longer periods should reflect a global assessment, such as whether the patient’s asthma is better or worse since the last visit. At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma control. In general, more frequent and intense exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate poorer disease control. 26 Figure 5: Stepwise Approach for Managing Asthma Long Term in Children Stepwise Approach for Managing Asthma Long Term in Children, 0-4 Years of Age and 5-11 Years of Age Step up if needed (first check inhaler technique, adherence, environmental control, and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) Step 1 Step 2 Children 0-4 Years of Age SABA PRN Alternative Step 5 Step 6 Low-dose ICS Medium-dose ICS Medium-dose ICS + LABA or Montelukast High-dose ICS + LABA or Montelukast High-dose ICS + LABA or Montelukast + Oral corticosteroids ICS Cromolyn or Montelukast Each step: Patient Education and Environmental Control Quick-Relief Medications o o SABA as needed for symptoms; intensity of treatment depends on severity of symptoms. With viral respiratory symptoms SABA 4-6 hours up to 24 hours (longer with physician consult). Consider short course of oral systemic corticosteroids if exacerbation is severe or patient has history of previous severe exacerbations. Caution: frequent use of SABA may indicate the need to step up treatment. See recommendations on initiating daily long-term control therapy. Intermittent Asthma Children 5-11 Years of Age Step 4 Persistent Asthma: Daily Medication Consult with asthma specialist if step 3 care of higher is required. Consider consultation at step 2. Intermittent Asthma Preferred Step 3 Preferred SABA PRN Persistent Asthma: Daily Medication Consult with asthma specialist if step 3 care of higher is required. Consider consultation at step 2. Low-dose ICS Low-dose ICS + LABA, LTRA, or Theophylline OR Medium-dose ICS Alternative Medium-dose ICS + LABA High-dose ICS + LABA High-dose ICS + LABA + Oral corticosteroids Medium-dose ICS + LTRA or Theophylline High-dose ICS + LTRA or Theophylline High-dose ICS + LTRA or Theophylline + Oral corticosteroids Each Step: Patient Education, Environmental Control and Management of Comorbidities Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have persistent, allergic asthma. o Quick-Relief Medications SABA as needed for symptoms , intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minute intervals as needed. Short course of oral systemic corticosteroids may be needed. Caution: Increasing use of SABA or use >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment. Notes: Children 0-4 Years of Age Notes: Children of 5-11 Years of Age Key: ICS, inhaled corticosteroid; LABA, inhaled long-acting beta2-agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta2-agonist. If an alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. If clear benefit is not observed within 4-6 weeks, and patients/family’s medication technique and adherence are satisfactory, consider adjusting therapy or an alternative diagnosis. Studies on children 0-4 years of age are limited. Step 2 preferred therapy is based on Evidence A. All other recommendations are based on expert opinion and extrapolation from studies in older children. Clinicians who administer immunotherapy should be prepared and equipped to identify and treat anaphylaxis that may occur. If an alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. Theophylline is a less desirable alternative due to the need to monitor serum concentration levels. Steps 1 and 2 medications are based on Evidence A. Step 3 ICS and ICS plus adjunctive therapy are based on Evidence B for efficacy of each treatment and extrapolation from comparator trials in older children and adults—comparator trials are not available for this age group; steps 4-6 are based on expert opinion and extrapolation from studies in other children and adults. Immunotherapy for steps 2-4 is based on Evidence B for house dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than adults. Clinicians who administer immunotherapy should be prepared and equipped to identify and treat anaphylaxis that may occur. 27 Figure 6: Classification of Asthma Severity ≥12 years Classification of Asthma Severity ≥12 years Components of Severity Persistent Intermittent Symptoms Nighttime Awakenings Mild Moderate Severe ≤2 days/week >2 days/week but not daily Daily Throughout the day ≤2x/month 3-4x/month >1x/week but not nightly Often 7x/week ≤2 days/week >2 days/week but not daily, and not more than 1x on any day Daily Several times per day None Minor limitation Some limitation Extremely limited Impairment Short-acting beta2-agonist use for Normal FEV1/FVC symptom control (not prevention of 8-19 yr 85% EIB) 20-39 yr 80% 40-59 yr 75% 60-80 yr 70% Interference with normal activity o Lung function o o Normal FEV1 between exacerbations FEV1 >80% predicted FEV1 /FVC normal o FEV1 >80% predicted o FEV1 /FVC normal 0-1/year (see notes) Risk Exacerbations requiring oral systemic corticosteroids o FEV1 >60% but <80% predicted o FEV1 /FVC reduced 5% o FEV1 <60% predicted o FEV1 /FVC reduced >5% ≥2 year (see note) Consider severity and interval since last exacerbation. Frequency and severity may fluctuate over time for patients in any severity category. Relative annual risk of exacerbations may be related for FEV1. Step 3 Recommended step for initiation therapy Step 1 Step 4 Step 2 (See “Stepwise Approach for Managing Asthma” for treatment steps) And consider short course of oral systemic corticosteroids In 2-6 weeks, evaluate level of asthma control that is achieved and adjust therapy accordingly. Key: EIB, exercise-induced bronchospasm, FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICU, intensive care unit Notes: • Level of severity is determined by assessment of both impairment and risk. • Assess impairment domain by patient’s/caregiver’s recall of previous 2–4 weeks and spirometry. Assign severity to the most severe category in which any feature occurs. • At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma severity. In general, more frequent and intense exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate greater underlying disease severity. For treatment purposes, patients who had ≥2 exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have persistent asthma, even in the absence of impairment levels consistent with persistent asthma. 28 Figure 7: Assessing Asthma Control and Adjusting Therapy in Youths ≥12 Years of Age and Adults Assessing Asthma Control and Adjusting Therapy in Youths ≥12 Years of Age and Adults Components of Control Symptoms Nighttime Awakenings Interference with normal activity Impairment Short-acting beta2-agonist use for symptom control (not prevention of EIB) FEV1 or peak flow Validated questionnaires ATAQ ACQ ACT Not Well Controlled Very Poorly Controlled ≤2 days/week >2 days/week Throughout the day ≤2x/month 1-3x/week ≥4x/week None Some limitation Extremely limited ≤2 days/week >2 days/week Several times per day >80 % predicted/personal best 60-80% predicted/personal best <60% predicted/personal best 0 ≤0.75* ≥20 1-2 ≥1.5 16-19 3-4 N/A ≤15 0-1/year Exacerbations requiring oral systemic corticosteroids Risk Well Controlled ≥2/year (see note) Consider severity and interval since last exacerbation. Progressive loss of lung function Evaluation requires long-term follow-up care. Treatment-related adverse effects Medication side effects can vary in intensity from none to very troublesome and worrisome. The level of intensity does not correlate to specific levels of control, but should be considered in the overall assessment of risk. Recommended action for treatment (See “Stepwise Approach for Managing Asthma” for treatment steps) o o o Maintain current step o Regular follow-up every 1-6 o months to maintain control o Consider step down if well controlled for at least 3 months. o Step up 1 step Reevaluate in 2-6 weeks o For side effects, consider o alternative treatment options o Consider short course of oral systemic corticosteroids Step up 1-2 steps Reevaluate in 2 weeks For side effects, consider alternative treatment options *ACQ values of 0.76–1.4 are indeterminate regarding well-controlled asthma. Key: EIB, exercise-induced bronchospasm; ICU, intensive care unit Notes: • The level of control is based on the most severe impairment or risk category. Assess impairment domain by patient’s recall of previous 2–4 weeks and by spirometry/or peak flow measures. Symptom assessment for longer periods should reflect a global assessment, such as inquiring whether the patient’s asthma is better or worse since the last visit. • At present, there are inadequate data to correspond frequencies of exacerbations with different levels of asthma control. In general, more frequent and intense exacerbations (e.g., requiring urgent, unscheduled care, hospitalization, or ICU admission) indicate poorer disease control. For treatment purposes, patients who had ≥2 exacerbations requiring oral systemic corticosteroids in the past year may be considered the same as patients who have not-well-controlled asthma, even in the absence of impairment levels consistent with not-well-controlled asthma. ATAQ = Asthma Therapy Assessment Questionnaire© ACQ = Asthma Control Questionnaire© ACT = Asthma Control Test™ Minimal Important Difference: 1.0 for the ATAQ; 0.5 for the ACQ; not determined for the ACT. Before step up in therapy: — Review adherence to medication, inhaler technique, environmental control, and comorbid conditions. — If an alternative treatment option was used in a step, discontinue and use the preferred treatment for that step. 29 Figure 8: Stepwise Approach for Managing Asthma in Youths ≥12 Years of Age and Adults Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Intermittent Asthma Step 6 High-dose ICS + LABA + oral corticosteroid (First, check adherence, environmental control, and comorbid conditions) AND Assess Control Consider Omalizumab for patients who have allergies Step down if possible Preferred: Step 5 Step 3 Step 2 Preferred: Low-dose ICS Step 1 Preferred: SABA PRN Alternative: Cromolyn, LTRA, Nedocromil, or Theophylline Preferred: Low-dose ICS + LABA OR Medium-dose ICS Alternative: Low-dose ICS + either LTRA, Theophylline, or Zileuton Step 4 Preferred: Medium-dose ICS + LABA Alternative: Medium-dose ICS+ either LTRA, Theophylline, or Zileuton Preferred: High-dose ICS + LABA AND Consider Omalizumab for patients who have allergies Step up if needed (And asthma is well controlled at least 3 months) Each step: Patient education, environmental control, and management of comorbidities. Steps 2-4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma (see notes). o o Quick -relief medication for all patients: SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms: up to 3 treatments at 20-minutes intervals as needed. Short course of oral systemic corticosteroids may be needed. Use of SABA >2 days a week for symptom relief (not prevention of EIB) generally indicates inadequate control and the need to step up treatment. Note: Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. Key: ICS, inhaled corticosteroid; LABA, long acting inhaled beta2-agonist; LTRA, leukotriene receptor antagonist; SABA, inhaled short-acting beta2-agonist Notes: • If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up. • Zileuton is a less desirable alternative due to limited studies as adjunctive therapy and the need to monitor liver function. Theophylline requires monitoring of serum concentration levels. • In step 6, before oral corticosteroids are introduced, a trial of high-dose ICS + LABA + either LTRA, theophylline, or zileuton may be considered, although this approach has not been studied in clinical trials. • Step 1, 2, and 3 preferred therapies are based on Evidence A; step 3 alternative therapy is based on Evidence A for LTRA, Evidence B for theophylline, and Evidence D for zileuton. Step 4 preferred therapy is based on Evidence B, Disclaimer: areondesigned assistandclinicians byand providing framework and alternative Guidelines therapy is based Evidence B to for LTRA theophylline Evidence Da zileuton. Step 5for the evaluation and preferred therapy is based This on Evidence B. Step 6 preferred is based on (EPR—2for 1997) andpatients. Evidence B It foris not intended to treatment of patients. guideline outlines thetherapy preferred approach most omalizumab. replace a clinician’s judgment or to establish a protocol for all patients. It is understood that some patients will • Immunotherapy for steps 2–4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is notweak fit the clinical condition contemplated byisastrongest guideline and that a guideline will rarely the only or lacking for molds and cockroaches. Evidence for immunotherapy with single allergens. Theestablish role of allergy in asthma is greater children than in adults. appropriate approach to ain problem. • Clinicians who administer immunotherapy or omalizumab should be prepared and equipped to identify and treat anaphylaxis that may occur. 30 EVIDENCE/REFERENCES 1. 2. 3. Guidelines for the Diagnosis and Management of Asthma (Summary Report). http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf. Updated 2007. Accessed September 23, 2011. Guidelines for the Diagnosis and Management of Asthma. http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf. Updated 2007. Accessed September 23, 2011. Managing Asthma During Pregnancy: Recommendations for Pharmacologic Treatment (Quick Reference). http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg/astpreg_qr.pdf. Updated 2004. Accessed September 23, 2011. PREPARATION OF EVIDENCE TABLES Evidence tables were prepared for selected topics. It was not feasible to generate evidence tables for every topic in the guidelines. Furthermore, many topics did not have a sufficient body of evidence or a sufficient number of high-quality studies to warrant the preparation of a table. The Panel decided to prepare evidence tables on those topics for which an evidence table would be particularly useful to assess the weight of the evidence—e.g., topics with numerous articles, conflicting evidence, or which addressed questions raised frequently by clinicians. Summary findings on topics without evidence tables, however, also are included in the updated guidelines text. Evidence tables were prepared with the assistance of a methodologist who served as a consultant to the Expert Panel. Within their respective committees, Expert Panel members selected the topics and articles for evidence tables. The evidence tables included all articles that received a “yes” vote from both the primary and secondary reviewer during the systematic literature review process. The methodologist abstracted the articles to the tables, using a template developed by the Expert Panel. The Expert Panel subsequently reviewed and approved the final evidence tables. A total of 20 tables, comprising 316 articles are included in the current update (see figure 1–1). Evidence tables are posted on the NHLBI Web site: http://www.nhlbi.nih.gov/guidelines/asthma/evid_tbls.htm RANKING THE EVIDENCE The Expert Panel agreed to specify the level of evidence used to justify the recommendations being made. Panel members only included ranking of evidence for recommendations they made based on the scientific literature in the current evidence review. They did not assign evidence rankings to recommendations pulled through from the EPR—2 1997 on topics that are still important to the diagnosis and management of asthma but for which there was little new published literature. These “pull through” recommendations are designated by EPR—2 1997 in parentheses following the first mention of the recommendation. For recommendations that have been either revised or further substantiated on the basis of the evidence review conducted for the EPR—3: Full Report 2007, the level of evidence is indicated in the text in parentheses following first mention of the recommendation. The system used to describe the level of evidence is as follows (Jadad et al. 2000): Evidence Category A: Randomized controlled trials (RCTs), rich body of data. Evidence is from end points of well-designed RCTs that provide a consistent pattern of findings in the population for which the recommendation is made. Category A requires substantial numbers of studies involving substantial numbers of participants. Evidence Category B: RCTs, limited body of data. Evidence is from end points of intervention studies that include only a limited number of patients, post hoc or subgroup analysis of RCTs, or metaanalysis of RCTs. In general, category B pertains when few randomized trials exist; they are small in size, they were undertaken in a population that differs from the target population of the recommendation, or the results are somewhat inconsistent. Evidence Category C: Nonrandomized trials and observational studies. Evidence is from outcomes of uncontrolled or nonrandomized trials or from observational studies. 31 Evidence Category D: Panel consensus judgment. This category is used only in cases where the provision of some guidance was deemed valuable, but the clinical literature addressing the subject was insufficient to justify placement in one of the other categories. The Panel consensus is based on clinical experience or knowledge that does not meet the criteria for categories A through C. In addition to specifying the level of evidence supporting a recommendation, the Expert Panel agreed to indicate the strength of the recommendation. When a certain clinical practice “is recommended,” this indicates a strong recommendation by the panel. When a certain clinical practice “should, or may, be considered,” this indicates that the recommendation is less strong. This distinction is an effort to address nuances of using evidence ranking systems. For example, a recommendation for which clinical RCT data are not available (e.g., conducting a medical history for symptoms suggestive of asthma) may still be strongly supported by the Panel. Furthermore, the range of evidence that qualifies a definition of “B” or “C” is wide, and the Expert Panel considered this range and the potential implications of a recommendation as they decided how strongly the recommendation should be presented. ACKNOWLEDGEMENTS Disclaimer: Guidelines are designed to assist clinicians by providing a framework for the evaluation and treatment of patients. This guideline outlines the preferred approach for most patients. It is not intended to replace a clinician’s judgment or to establish a protocol for all patients. It is understood that some patients will not fit the clinical condition contemplated by a guideline and that a guideline will rarely establish the only appropriate approach to a problem. 32
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