Classifying Asthma Severity and Initiating Treatment in Children 0 4 Years of Age

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1 Classifying Asthma Severity and Initiating Treatment in Children 0 4 Years of Age Components of Severity Symptoms Intermittent 2 days/week Classification of Asthma Severity (0 4 years of age) Persistent Mild Moderate Severe > 2 days/week but not daily Daily Throughout the day Impairment Risk Nighttime awakenings 0 1 2x/month 3 4x/month >1x/week Short acting beta 2 agonist use for symptom control (not prevention of EIB) Interference with normal activity Exacerbations requiring oral systemic corticosteroids 2 days/week > 2 days/week but not daily Daily Several times per day None Minor limitation Some limitation Extremely limited 0 1/year 2 exacerbations in 6 months requiring oral systemic corticosteroids, or 4 wheezing episodes/1 year lasting > 1 day AND risk factors for persistent asthma Consider severity and interval since last exacerbation Frequency and severity may fluctuate t over time Exacerbations of any severity may occur in patients in any severity category Recommended Step for Initiating Treatment Step 1 Step 2 Step 3 and consider short course of oral systemic corticosteroids In2 6 weeks, dependingon severity, evaluate level of asthma control that is achieved. If no clear benefit is observed in 4 6 weeks, consider adjusting therapy or alternative diagnosis EIB = exercise induced bronchospasm National Asthma Education and Prevention Program. Publication No Available from:

2 Classifying Asthma Severity and Initiating Treatment in Children 5 11 Years of Age Components of Severity Intermittent Classification of Asthma Severity (5 11 years of age) Persistent Mild Moderate Severe Symptoms 2 days/week > 2 days/week kbut not daily dil Dil Daily Throughout h the day Impairment Nighttime awakenings 2x/month 3 4x/month > 1x/week but not nightly Often 7x/week Short acting beta 2 agonist use for symptom control 2 days/week > 2 days/weekbut not daily Daily Several times per day (not prevention of EIB) Interference with normal activity None Minor limitation Some limitation Extremely limited Lung function Normal FEV 1 between exacerbations FEV 1 > 80% predicted FEV 1 /FVC >85% FEV 1 = >80% predicted FEV 1 /FVC >80% FEV 1 = 60 80% predicted FEV 1 /FVC =75 80% FEV 1 < 60% predicted FEV 1 /FVC <75% Risk 0 1/year 2/year Exacerbations requiring oral systemic corticosteroids Consider severity and interval since last exacerbation Frequency and severity may fluctuate over time for patients in any severity category Recommended Step for Initiating Treatment Relative annual risk of exacerbations may be related to FEV 1 Step 3, medium dose ICS option Step 1 Step 2 Step 3, medium dose ICS option, or Step 4 and consider short course of oral systemic corticosteroids In 2 6 weeks, evaluate level of asthma control that is achieved, and adjust therapy accordingly FEV 1 = forced expiratory volume in 1 second; FVC = forced vital capacity; ICS = inhaled corticosteroids National Asthma Education and Prevention Program. Publication No Available from:

3 FDA Approved Agents in Children ICS Age indications Mometasone 110 mcg ages 4 to 11, 220 mcg down to age 12 Budesonide MDI down to age 6, respules down to age 12 months to 8 years Fluticasone MDI and Diskus down to age 4 Beclomethasone Down to age 5 Ciclesonide Down to age 12 ICS + LABA Age Indication Fluticasone/salmeterol MDI down to age 12 years, Diskus down to age 4 years Budesonide/formoterol MDI down to age 12 years Mometasone/formoterol MDI down to age 12 years LABA = long acting beta agonist; MDI = meter dose inhaler National Asthma Education and Prevention Program. Publication No Available from:

4 FDA Approved LTRA Agents in Adults Leukotriene Receptor Antagonists Doses Zafirlukast 10 mg twice daily ages 5 11 Montelukast 4 mg oral granules ages 6 23 months, 4 mg oral granules or oral tablet ages 2 5, 5 mg chewable tablet ages 6 14 LTRA L k t i R t At it LTRA = Leukotriene Receptor Antagonists National Asthma Education and Prevention Program. Publication No Available from:

5 Stepwise Approach for Managing Asthma in Children 0 4 Years of Age Intermittent Asthma Step 1 short acting beta2 agonist (SABA) As needed Step 2 Low dose ICS Cromolyn or Montelukast Persistent Asthma: Daily Medication Consult with asthma specialist if step 3 care or higher is required. Consider consultation at step 2. Step 3 Mediumdose ICS Step 4 Mediumdose ICS + either LABA or Montelukast Step 5 High dose ICS + either LABA or Montelukast Patient Education and Environmental Control at Each Step Step 6 High dose ICS + either LABA or Montelukast Oral systemic Corticosteroids Quick Relief Medication for All Patients SABA as needed for symptoms. Intensity of treatment depends on severity of symptoms. With viral respiratory infection: SABA q 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 text for recommendations on initiating daily long term control therapy. Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. National Asthma Education and Prevention Program. Publication No Available from: Step up if needed (first, check adherence, inhaler technique, and environmental control) Assess control Step down if possible (and asthma is well controlled at least 3 months)

6 Stepwise Approach for Managing Asthma in Children 5 11 Years of Age Intermittent Asthma Step 1 Step2 Low dose ICS SABA Cromolyn, As needed LTRA, Nedocromil, or Theophylline Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Step 3 EITHER: Low dose ICS + either LABA, LTRA, or Theohylline OR medium dose ICS Step 4 Medium dose ICS + LABA Medium dose ICS+ either LTRA or Theophylline Step 5 High dose ICS + LABA High dose ICS + either LTRA or Theophylline Step 6 High dose ICS + LABA + oral systemic corticosteroid High dose ICS + either LTRA or Theophylline + oral systemic corticosteroid Each step: Patient education, environmental control, and management of comorbidities. Steps 2 4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma* 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 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. Step up if needed (first, check adherence, inhaler technique, and environmental control, and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) Alphabetical order is used when more than one treatment option is listed within either preferred or alternative therapy. National Asthma Education and Prevention Program. Publication No Available from:

7 Assessing Asthma Control and Adjusting Therapy in Children 0 4 Years of Age Components of Control Classification of Asthma Control (0 4 years of age) Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week > 2 days/week Throughout the day Nighttime awakenings 1x/month > 1x/month >1x/week Impairment Risk Interference with normal activity Short acting beta 2 agonist use for symptom control (not prevention of EIB) Exacerbations requiring oral systemic corticosteroids Treatment related adverse effects None Some limitation Extremely limited 2 days/week > 2 days/week Several times per day 0 1/year 2 3/year > 3/year Medication side effects can very 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 Maintain current treatment Regular follow up every 1 6 months Consider step down if well controlled for at least 3 months Step up (1 step) and Reevaluate in 2 6 weeks If no clear benefit in 4 6 weeks, consider alternative diagnoses or adjusting therapy For side effects, consider alternative ate at eteat treatment e t options Consider short course of oral systemiccorticosteroids ti t id Step up (1 2 steps), and Reevaluate in 2 weeks If no clear benefit in 4 6 weeks, consider alternative diagnoses or adjusting therapy For sdee side effects, ects,consider alternative treatment options National Asthma Education and Prevention Program. Publication No Available from:

8 Assessing Asthma Control and Adjusting Therapy in Children 5 11 Years of Age Components of Control Classification of Asthma Control (5 11 years of age) Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week but not more than once on each day > 2 days/week or multiple times on 2 days/month Throughout the day Nighttime awakenings 1x/month 2x/month > 2x/week Impairment Interference with normal activity None Some limitation Extremely limited Short acting beta 2 agonist use for symptom control (not 2 days/week 2 days/week Several times per day prevention of EIB) Lung function FEV 1 or peak flow FEV 1 /FVC > 80% predicted/personal best > 80% 60 80% predicted/personal best 75 80% < 60% predicted/personal best < 75% Risk Exacerbations requiring ii oral 0 1/year 2/year systemic corticosteroids Consider severity and interval since last exacerbation Reduction in lung growth Evaluation requires long term follow up Medication side effects can vary in intensity from none to very troublesome and worrisome. The level Treatment related adverse of intensity does not correlate to specific levels of control but should be considered in the overall effects ects assessment of risk ik Recommended Action for Treatment Maintain current step Regular follow up every 1 6 months Consider step down if well controlled for at least 3 months Step up at least 1 step and Reevaluate in 2 6 weeks For side effects, consider alternative treatment options Consider short course of oral systemic corticosteroids Step up 1 2 steps, and Reevaluate in 2 weeks Forside effects, consider alternative treatment options National Asthma Education and Prevention Program. Publication No Available from:

9 Classifying Asthma Severity and Initiating Treatment in Persons 12 Years of Age Impairment Components of Severity Symptoms Intermittent 2 days/week Classification of Asthma Severity ( 12 years of age) Persistent Mild Moderate Severe > 2 days/week but not daily Nighttime awakenings 2x/month 3 4x/month Daily > 1x/week but not nightly Throughout the day Often 7x/week Normal Short acting beta agonist use > 2 days/week 2 g 2 days/week FEV 1 /FVC: for symptom control (not but not daily, and not Daily Several times per day 8 19 yr: 85% prevention of EIB) more than 1x on any day yr: 80% Interference with normal activity None Minor limitation Some limitation Extremely limited yr: 75% Normal FEV 1 between FEV 1 > 60% but yr: 70% exacerbations FEV 1 > 80% predicted < 80% predicted FEV 1 < 60% predicted Lung function FEV 1 > 80% predicted FEV 1 /FVC normal FEV 1 /FVC reduced FEV 1 /FVC reduced > 5% FEV 1 /FVC normal 5% Risk Exacerbations requiring oral systemic corticosteroids 0 1/year 2/year 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 to FEV 1 Recommended Step for Initiating Treatment Step 1 Step 2 Step 3 Step 4 or 5 and consider short course of oral systemic corticosteroids In 2 6 weeks, evaluate level of asthma control that is achieved and adjust therapy accordingly National Asthma Education and Prevention Program. Publication No Available at:

10 Stepwise Approach for Managing Asthma in Youths 12 Years of Age and Adults Intermittent Asthma Step 1 SABA As needed Persistent Asthma: Daily Medication Consult with asthma specialist if step 4 care or higher is required. Consider consultation at step 3. Step2 Low dose ICS Cromolyn, LTRA, Nedocromil, or Theophylline Step 3 Low dose ICS + LABA OR mediumdose ICS low dose ICS + either LTRA, Theophylline, or Zileuton Step 4 Medium dose ICS + LABA Mediumdose ICS+either LTRA, Theophylline, or Zileuton Step 5 High dose ICS + LABA AND Consider Omalizumab for patients who have allergies Step 6 High dose ICS + LABA + oral corticosteroid AND Consider Omalizumab for patients who have allergies Each step: Patient education, environmental control, and management of comorbidities. Steps 2 4: Consider subcutaneous allergen immunotherapy for patients who have allergic asthma 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 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. Step up if needed (first, check adherence, environmental control, and comorbid conditions) Assess control Step down if possible (and asthma is well controlled at least 3 months) National Asthma Education and Prevention Program. Publication No Available from:

11 Assessing Asthma Control and Adjusting Therapy in Youth 12 Years of Age and Adults Components of Control Classification of Asthma Control ( 12 years ofage) Well Controlled Not Well Controlled Very Poorly Controlled Symptoms 2 days/week >2 days/week Throughout the day Nighttime awakenings 2x/month 1 3x/week 4x/week Interference with normal activity it None Some limitation Extremely limited Impairment Short acting beta 2 agonist use for symptom control (not prevention of EIB) FEV 1 or peak flow Validated Questionnaires ATAQ ACQ ACT Exacerbations requiring oral systemic corticosteroids 2 days/week >2 days/week Several times per day > 80% predicted/ personal best * % predicted/ personal best /year 2/year Consider severity and interval since last exacerbation < 60% predicted/ personal best 3 4 N/A 15 Risk Progressive loss of lung function Treatment related adverse effects Recommended Action for Treatment Evaluation requires long term follow up care 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 Maintain current step Regular follow ups every 1 6 months to maintain control Consider step down if well controlled for at least 3 months Step up 1 step and Reevaluate in 2 6 weeks Forside effects, consider alternative treatment options National Asthma Education and Prevention Program. Publication No Available from: Consider short course of oral systemic corticosteroids, Step up 1 2 steps, and Reevaluate in 2 weeks For side effects, consider alternative treatment options

12 FDA Approved ICS and Combination Agents in Adults ICS Mometasone Budesonide Doses Twisthaler 110 mcg or 220 mcg Flexhaler 90 mcg or 180 mcg Respules 0.25 & 0.5 mg or 1mg/2mL Fluticasone Diskus 50 mcg, 100 mcg or 250 mcg MDI 110 mcg or 220 mcg Beclomethasone MDI 40 mcg or 80 mcg Ciclesonide ICS + LABA MDI 80 mcg or 160 mcg Doses Fluticasone/salmeterol MDI 45/21, 115/21, 230/21 Diskus 100/50, 250/50 or 500/50 Budesonide/formoterol MDI 80/4.5 or 160/4.5 Mometasone/formoterol MDI 100/5 or 200/5 National Asthma Education and Prevention Program. Publication No Available from:

13 FDA Approved LTRA Agents in Adults Leukotriene Receptor Antagonists Zafirlukast Montelukast Doses 20 mg tablets 10 mg tablets National Asthma Education and Prevention Program. Publication No Available from:

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