Using Inhaled Corticosteroids as Needed for Asthma: giving patients relief or leaving them breathless?

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1 Using Inhaled Corticosteroids as Needed for Asthma: giving patients relief or leaving them breathless? Lindsay Thomas, Pharm.D. PGY2 Ambulatory Care Resident Department of Pharmacotherapy and Pharmacy Services, University Health System Pharmacotherapy Division, the University of Texas at Austin College of Pharmacy Pharmacotherapy Education and Research Center, University of Texas San Antonio March 8 th, 2019 Learning Objectives: 1. Describe the disease state, classification, and current guideline recommended management of asthma 2. Discuss adherence and complications associated with asthma 3. Review the current literature regarding using inhaled corticosteroids as needed for management of mild persistent asthma 4. Summarize when using inhaled corticosteroids as needed is appropriate for mild persistent asthma

2 Assessment questions: 1. What is the American guideline recommended 1 st line maintenance treatment for mild persistent asthma? A. Inhaled corticosteroid B. Long-acting beta 2 agonist C. Theophylline D. Leukotriene receptor antagonist 2. What estimated percent of patients with asthma are adherent to their maintenance inhaler regimen? A. 5-10% B % C % D % 3. True or False: Inhaled corticosteroids used as needed demonstrated similar control of symptoms and exacerbations to daily inhaled corticosteroids in the SYGMA trials. A. True B. False ***To Obtain CE credit for attending this program please sign in. Attendees will be ed a link to an electronic CE Evaluation Form. CE credit will be awarded upon completion of the electronic form. If you do not receive an within 72 hours, please contact the CE Administrator at ana.francomartinez@uhs-sa.com*** Faculty (Speaker) Disclosure: Lindsay Thomas has indicated she has no relevant financial relationships relative to the content of her presentation. Thomas 2

3 Background Asthma is a chronic inflammatory disorder of the airways 1-3 Common characteristics: episodic airflow limitation, bronchial hyperresponsiveness, underlying inflammation, and reversible airway obstruction Symptoms: wheezing, breathlessness, cough, chest tightness Epidemiology in the United States 4,5 Prevalence (2016): 26,515,000 Asthma related deaths (2016): 3,518 /year Persons having > 1 asthma attack (2016): 12,426,000/year Asthma related inpatient hospital discharges (2010): 439,435/year Asthma related emergency department visits (2015): 1,700,000/year Asthma related physician visits (2014): 11,000,000/year Pathophysiology 1-3 Airway inflammation is a major factor in determining severity, cell/mediator pattern, and treatment response Recurrent airflow limitation is caused by a variety of changes o Bronchoconstriction: can be induced by allergens, medications (e.g., aspirin, nonsteroidal anti-inflammatory drugs), exercise, cold air, irritants (e.g., chemicals, tobacco smoke) o Airway edema o Airway hyperresponsiveness o Airway remodeling Diagnosis 1-3,6-8 Must determine presence of episodic airflow obstruction and airway hyperresponsiveness symptoms, at least partially reversible airflow obstruction, exclusion of other diagnosis Tools used for diagnosis o Detailed medical history o Physical examination of upper respiratory tract, chest, and skin o Spirometry (Appendix A, Section a) 5 o Patient Assessment Questionnaires (Appendix A, Section b) 6-7 Classification (Appendix B) 1-3 Four classes 1. Intermittent 3. Moderate persistent 2. Mild persistent 4. Severe persistent Considers o Frequency of symptoms o Nighttime awakenings due to asthma symptoms o Use of short-acting beta 2 agonist (SABA) o Interference with normal activity o Lung function o Exacerbation requiring systemic corticosteroids Thomas 3

4 Treatment 1-3 Goals o o Reduce impairment of daily activities Prevent symptoms Maintain normal pulmonary function Maintain normal activity levels Reduce risk of exacerbation Minimize need of emergency department (ED) visits or hospitalizations Prevent progressive loss of lung function Use the stepwise approach to determine medication therapy (Table 1) o Initial step is based on asthma classification (Figure 1, Appendix C) o Use stepwise approach to make medication adjustments Assess asthma control (Appendix D) Initial: every 2-6 weeks until controlled Maintenance: every 1-6 months To step up Address the following considerations: quality of life impairment, risk of exacerbation, adherence, environmental control, comorbid conditions To step down, patient MUST be well-controlled for 3 months Figure 1: Stepwise approach to therapy Source: figure 16. Summary report Guidelines for the diagnosis and management of asthma. NHLBI Thomas 4

5 1-3, 9-45 Table 1: Medication classes Beta 2 Agonists Medications SABAs: albuterol, levalbuterol, terbutaline LABAs: formoterol (similar time of onset as short-acting), salmeterol, vilanterol MOA agonize beta 2 receptors which increases camp leading to relaxation of airway smooth muscle AE tachycardia, QTc prolongation, hypokalemia, tremor, hyperglycemia Place in therapy SABAs: rescue therapy LABAs: used in combination with ICS for long-term control of asthma CANNOT be used as monotherapy in asthma Inhaled Corticosteroids Medications budesonide, fluticasone, beclomethasone, mometasone, ciclesonide MOA block late-phase reaction to allergen, reduce airway hyperresponsiveness, inhibit inflammatory cell migration and activation AE oral candidiasis, dysphonia, reflex cough, bronchospasm, and reduction in growth rate (children and adolescents) Place in therapy long-term control of asthma for mild, moderate, or severe persistent asthma (monotherapy or in combination) Anticholinergics Medications short-acting: ipratropium long-acting: tiotropium MOA inhibit muscarinic cholinergic receptors leading to bronchodilation AE dry mouth, increase wheezing, blurred vision, decreased respiratory secretions Place in therapy short-acting: moderate or severe asthma exacerbations in ED with SABA long-acting: tiotropium is FDA approved and currently recommended by GINA Leukotrienes Receptor Antagonists Medications montelukast, zafirlukast MOA block the effects of leukotrienes leading to reduce inflammation AE headache, dizziness, fatigue, skin rash, cough Place in therapy alternative (NOT preferred) for long-term control of mild persistent asthma; use as adjunctive therapy with ICS 5-Lipoxygenase Inhibitor Medications zileuton, zileuton CR MOA inhibits production of leukotriene leading to reduce inflammation AE elevated liver enzymes, hepatitis, hyperbilirubinemia Place in therapy alternative for adults (less preferred than LTRAs) Mast Cell Stabilizer Medications cromolyn MOA stabilize mast cells and eosinophil recruitment, interfere with chloride channel function AE chest pain, edema, headache, irritability, skin rash, photosensitivity, diarrhea, nausea, abdominal pain, constipation, neutropenia Place in therapy alternative (NOT preferred) for long-term control of mild persistent asthma Methylxanthines Medications theophylline MOA non-selectively inhibits phosphodiesterase leading to bronchodilation AE headache, nausea/vomiting, tachycardia, insomnia, hyperglycemia, hypokalemia, gastric upset, seizures Place in therapy alternative (NOT preferred) for long-term control of mild persistent asthma; use as adjunctive therapy with ICS (NOT preferred) Thomas 5

6 Immunomodulators Medications benralizumab, mepolizumab, omalizumab, reslizumab AE pain and bruising at injection site, anaphylaxis, malignant neoplasms Place in therapy long-term control of moderate or severe persistent allergic asthma inadequately controlled with ICS SABA: short-acting beta 2 agonist; LABA: long-acting beta 2 agonist; MOA: mechanism of action; AE: adverse effects; camp: cyclic adenosine monophosphate; ICS: inhaled corticosteroids; FDA: Food and Drug Administration; GINA: Global Initiative for Asthma; ED: emergency department; LTRA: leukotriene receptor antagonist; CR: controlled release Adherence 1-3,46 Estimated adherence to inhale corticosteroids (ICS) maintenance therapy in asthma: 22-63% o Risk factors for nonadherence: children and adolescents, African Americans, mild asthma, low education level, and poor communication with healthcare providers Implications: higher percentage of eosinophils in sputum, increased use of oral corticosteroids increased hospitalization, higher mortality rate Complications 1-3 Exacerbations (see Appendix F for risk factors) Pneumonia Respiratory failure Death Literature Evaluating ICS as Needed in Asthma A 2013 Cochrane meta-analyses included 6 trials (n=1211) that evaluated ICS + SABA as needed (PRN) vs ICS maintenance therapy 47 Rates of exacerbation: ICS + SABA PRN had similar to ICS maintenance therapy Lung function, airway inflammation, asthma control, and reliever use: ICS maintenance therapy was superior to ICS + SABA PRN Table 2. O Byrne PM, et al. Inhaled combined budesonide-formoterol as needed in mild asthma (SYGMA 1). N Engl J Med. 2018;378: Objective To assess the long-term efficacy and safety of budesonide-formoterol PRN in mild persistent asthma Methods Design 52-week double-blind, randomized, parallel group, phase 3 trial involving patient > 12 years old with mild persistent asthma Population Inclusion criteria Exclusion criteria > 12 years old Worsening asthma within 30 days that Received asthma diagnosis > 6 required medication changes months before enrollment Use of systemic steroids within 30 days Needed GINA step 2 therapy > 30 Use of any ß-blocking agents days before visit 2 Smoker with > 10 pack-year History of life-threatening asthma Intervention 3 groups 1. Terbutaline PRN: placebo BID + terbutaline (0.5 mg) PRN 2. Budesonide-formoterol PRN: placebo BID + budesonide-formoterol (200 mcg/6mcg) PRN 3. Budesonide maintenance: budesonide (200 mcg) BID + terbutaline (0.5 mg) PRN Thomas 6

7 Primary outcomes Secondary outcomes Results Baseline characteristics Determine superiority of budesonide-formoterol used as needed over terbutaline used as needed in terms of asthma symptom scores, nighttime awakenings, morning peak expiratory flow, additional use of inhaled or systemic glucocorticoids Determine noninferiority of budesonide-formoterol used as needed to budesonide maintenance therapy in terms of weeks of well-controlled asthma, comparing rates and time to the 1 st severe exacerbation, rates and time to 1 st moderate-to-severe exacerbation, AQLQ, and ACQ-5 Safety (type, incidence, and severity of adverse events and by monitoring of vital signs) n=3836 Characteristic Terbutaline PRN (n=1277) Budesonideformoterol PRN (n=1277) Budesonide maintenance (n=1282) Age years +STD Female sex n(%) 771 (60.4) 777 (60.8) 797 (62.2) Time since asthma 6.3 ( ) 6.5 ( ) 6.3 ( ) diagnosis years (range) ACQ-5 mean score +STD At trial entry At baseline ACQ-5 score > 1.5 n/total n(%) At trial entry At baseline 549/1160 (47.3) 602/1256 (47.9) 601/1174 (51.2) 649/1257 (51.6) AQLQ score +STD FEV 1 % of predicted value +STD Before bronchodilator use After bronchodilator use PEF > 80% predicted value in AM n/total n(%) Bronchodilator reversibility % +STD 568/1177 (48.3) 596/1257 (47.4) /1276 (28.4) 340/1277 (26.6) 376/1282 (29.3) Thomas 7

8 Primary outcome Asthma control according to pretrial treatment Uncontrolled with SABA alone n(%) Controlled with ICS or LTRA n(%) 565 (44.2) 712 (55.8) 565 (44.2) 712 (55.8) 576 (44.9) 706 (55.1) Severe exacerbation in previous 12 months n(%) 256 (20.0) 257 (20.1) 241 (18.8) Mean percentage of electronically recorded weeks with well-controlled asthma per patient in budesonide-formoterol group vs. terbutaline group: 34.4% vs 31.1% of weeks; OR: 1.14; 95% CI: ; p=0.046 Secondary outcome Mean percentage of electronically recorded weeks with well-controlled asthma per patient in budesonide-formoterol PRN group vs. budesonide maintenance group: 34.4% vs 44.4% of weeks; OR: 0.64; 95% CI: Rate of severe exacerbation budesonide-formoterol PRN group vs. terbutaline PRN group: 0.07 vs 0.20; RR: 0.36; 95% CI: Rate of severe exacerbation budesonide-formoterol PRN group vs. budesonide maintenance group: 0.07 vs 0.09; RR: 0.83; 95% CI: Time to 1 st exacerbation budesonide-formoterol PRN group vs. terbutaline PRN group: HR: 0.44, 95% CI: Time to 1 st exacerbation budesonide-formoterol PRN group vs. budesonide maintenance group: HR: 0.9; 95% CI: Adverse events increased in terbutaline PRN group o Terbutaline PRN group 545 (42.7%) o Budesonide-formoterol PRN group 485 (38.0%) o Budesonide maintenance group 512 (39.9%) Author s Conclusion Budesonide-formoterol PRN was superior to terbutaline PRN both for asthma symptom control and for reducing the risk of asthma exacerbations among patients with mild persistent asthma. Budesonide-formoterol PRN was inferior to budesonide maintenance therapy with asthma symptom control. However, budesonide-formoterol had similar reduction of exacerbation risk to budesonide maintenance therapy, at a substantially lower total glucocorticoid load and without the need to adhere to a BID maintenance therapy schedule. Thomas 8

9 Reviewer s Critique Strengths: Groups were similar 52-week duration Used electronic monitoring that required real-time recording Kept tract of ICS exposure Adherence ~80% Limitations: Terbutaline PRN is not the guideline recommended treatment for mild persistent asthma ICS PRN group included a fast-acting LABA Adherence ~80% Conclusion: Budesonide-formoterol PRN superior to terbutaline PRN in controlling mild persistent asthma Budesonide-formoterol PRN inferior to budesonide BID in controlling symptoms even though time to 1 st exacerbation was similar Budesonide-formoterol PRN had less ICS and systemic steroid GINA: Global Initiative for Asthma; BID: twice daily; PRN: as needed; AQLQ: Asthma Quality of Life Questionnaire; ACQ: Asthma Control Questionnaire; STD: standard deviation; FEV 1: forced expiratory volume in 1 second; PEF: peak expiratory flow; CI: confidence interval; OR: odds ratio; RR: rate ratio; HR: hazard ratio; ICS: inhaled corticosteroid; SABA: short-acting beta 2 agonist; LTRA: leukotriene receptor antagonist Table 3. Bateman ED, et al. As-needed budesonide-formoterol versus maintenance budesonide in mild asthma (SYGMA 2). N Engl J Med. 2018;378: Objective To determine if budesonide formoterol PRN is non-inferior to regular budesonide maintenance treatment in preventing severe exacerbations in patients with mild asthma Methods Design 52-week double-blind, randomized, parallel group, phase 3 trial involving patient > 12 years old with mild persistent asthma Population Inclusion criteria Exclusion criteria Intervention Primary outcomes Secondary outcomes Results Baseline characteristics > 12 years old Received asthma diagnosis > 6 months before enrollment Needed GINA step 2 therapy > 30 days before visit Asthma worsening that involved a change in treatment or use of glucocorticoids in previous 30 days History of > 10 pack-years History of life-threatening asthma 2 groups 1. Budesonide-formoterol PRN: placebo BID + budesonide-formoterol (200 mcg/6mcg) PRN 2. Budesonide maintenance: budesonide (200 mcg) BID + terbutaline (0.5 mg) PRN Annualized rate of severe exacerbation in both groups Time to severe exacerbation Use of inhaled and systemic glucocorticoids FEV 1 before bronchodilator use Trial specific asthma-related discontinuation Use of maintenance therapy and as-needed reliever therapy The percentage of reliever-free days ACQ-5 score, AQLQ score N=4176 Characteristic Age years Mean +STD Range Budesonideformoterol PRN (n=2089) Budesonide maintenance (n=2087) Thomas 9

10 Primary outcome Female sex n(%) 1208 (62.6) 1289 (61.8) Current smoking n(%) 53 (2.5) 54 (2.6) Time since asthma diagnosis years 7.9 ( ) 7.3 ( ) Median (range) ACQ-5 mean score +STD ACQ-5 score > 1.5 n/total n(%) 943/2043 (46.2) 1000/2037 (49.1) FEV 1 % of predicted value + STD Before bronchodilator use After bronchodilator use Bronchodilator reversibility % +STD Asthma control according to pretrial treatment Uncontrolled with SABA alone n(%) Controlled with ICS or LTRA n(%) Severe exacerbation in previous 12 months n(%) 0 1 > (45.9) 1130 (54.1) 1630 (78.0) 365 (17.5) 94 (4.5) 975 (46.7) 1112 (53.3) 1627 (78.0) 362 (17.3) 98 (4.7) Secondary outcome Use of inhaled and systemic glucocorticoids o Median daily dose in budesonide-formoterol group was 66 mcg and in budesonide maintenance group was 267 mcg (75% increase) Thomas 10

11 Author s Conclusion In patients with mild asthma, budesonide formoterol used as needed was noninferior to twice-daily budesonide with respect to the rate of severe asthma exacerbations during 52 weeks of treatment but was inferior in controlling symptoms. Patients in the budesonide formoterol group had approximately one quarter of the inhaled glucocorticoid exposure of those in the budesonide maintenance group. Reviewer s Critique Strengths: Compared to guideline recommended therapy Similar baseline characteristics Looked at steroid exposure (ICS and systemic steroids) Limitations: Adherence ~64% in maintenance group Did not assess markers of inflammation Conclusion: ICS maintenance therapy is better than ICS PRN ICS PRN has lower corticosteroid exposure GINA: Global Initiative for Asthma; BID: twice daily; PRN: as needed; AQLQ: Asthma Quality of Life Questionnaire; ACQ: Asthma Control Questionnaire; STD: standard deviation; FEV 1: forced expiratory volume in 1 second; PEF: peak expiratory flow; CI: confidence interval; OR: odds ratio; RR: rate ratio; HR: hazard ratio; ICS: inhaled corticosteroid; SABA: short-acting beta 2 agonist; LTRA: leukotriene receptor antagonist Thomas 11

12 Table 4. Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomized, double-blind, placebo-controlled trial. Lancet. 2011;377: Objective To establish whether discontinuation of daily inhaled corticosteroids in children with well controlled, mild persistent asthma is associated with an increased risk of exacerbations, and whether or not the use of beclomethasone plus albuterol for relief, with or without concomitant use of daily beclomethasone, provides better protection against exacerbations than does a rescue strategy that uses albuterol alone. Methods Design A 44-week randomized, double-blind, four-treatment trial with a 2x2 factorial design Population Inclusion criteria Exclusion criteria Between 6 and 18 years old Pre-bronchodilator FEV 1 <60% of predicted Naive to controller treatment and at 1 st visit had a history of 1-2 exacerbations in previous year Hospitalization due to asthma in previous year Treated for the previous 8 weeks with a monotherapy other than ICS Any asthma exacerbation in previous 3 months or > 2 in the previous year Their illness was controlled for previous 8 weeks on low-dose corticosteroids as monotherapy (< 160 mcg daily with beclomethasone equivalent) History of life-threatening asthma exacerbations that required intubation or mechanical ventilation or resulted in a hypoxic seizure Intervention 4 groups 1. Combined: beclomethasone BID + beclomethasone/albuterol PRN 2. Daily: beclomethasone BID + placebo/albuterol PRN 3. Rescue: placebo BID + beclomethasone/albuterol PRN 4. Placebo: placebo BID + placebo/albuterol PRN Primary Time to first exacerbation that required treatment with prednisone outcome Secondary FEV 1, FENO, symptom diaries and control and quality of life questionnaires, linear growth outcomes Results Baseline characteristics N=288 Characteristic Combined Daily (n=72) Rescue Placebo (n=74) (n=71) (n=71) Age years +STD Sex (male) n(%) 39 (55) 42 (58) 37 (52) 41 (55) White n(%) 50 (70) 51 (71) 57 (80) 59 (78) Height cm +STD Weight kg +STD Age at asthma diagnosis years +STD Age at onset of asthma symptoms years +STD ICS use in previous 54 (76) 59 (82) 51 (72) 57 (77) year n(%) LTRA use in previous 11 (16) 7 (10) 14 (20) 13 (18) n(%) > 1 steroid course in last year n(%) 19 (27) 19 (26) 24 (34) 21 (28) Thomas 12

13 Primary outcome Pre-bronchodilator FEV 1 % predicted +STD FEV 1 /FVC % +STD Hospital visit in previous year Mean +STD Secondary outcome Probability of 1 st exacerbation by the end of the trial: Combined: 31% Daily: 28% Rescue: 35% Placebo: 49% Frequency of exacerbation Placebo vs Daily: 49% vs. 28%, p=0.03 Placebo vs Combined: 49% vs. 31%, p=0.07 Placebo vs Rescue: 49% vs. 35%, p=0.07 Linear growth Placebo and rescue: 1.1 cm more of growth than combined and daily (p<0.0001) FEV 1 : no difference among groups in decline of FEV 1 FENO: increase in the rescue and placebo groups vs daily and combined groups (p<0.0001) Thomas 13

14 Author s Conclusion Children with mild persistent asthma should not be treated with rescue albuterol alone and the most effective treatment to prevent exacerbations is daily inhaled corticosteroids. Inhaled corticosteroids as rescue medication with albuterol might be an effective step-down strategy for children with well controlled, mild asthma because it is more effective at reducing exacerbations than is use of rescue albuterol alone. Use of daily inhaled corticosteroid treatment and related side-effects such as growth impairment can therefore be avoided. Reviewer s Critique Strengths: 4 different treatment arms Evaluated linear growth Children and adolescents only Limitations: Smaller study Children and adolescents only Deviated from original analysis plan due to subadditive interactions Conclusion: ICS daily should be our first choice to reduce exacerbations in mild persistent asthma ICS daily with PRN ICS + SABA demonstrated best control of asthma If growth impairment or ICS exposure is a concern, ICS PRN could be considered BID: twice daily; PRN: as needed; AQLQ: Asthma Quality of Life Questionnaire; ACQ: Asthma Control Questionnaire; STD: standard deviation; FEV 1: forced expiratory volume in 1 second; FENO: fractional exhaled nitric oxide; FVC: forced vital capacity; CI: confidence interval; OR: odds ratio; RR: rate ratio; HR: hazard ratio; ICS: inhaled corticosteroid; SABA: short-acting beta 2 agonist When is using ICS PRN as monotherapy appropriate? In mild persistent asthma, ICS maintenance therapy + SABA or ICS/SABA PRN should be 1 st line BUT, if the patient meets the following criteria, ICS PRN could be used o Asthma has been well-controlled for more than 3 months o Patient is non-adherent to ICS o Growth impairment is a concern Take home points 1. Over 26 million Americans have asthma 2. The recommended treatment for mild persistent asthma is ICS maintenance therapy + SABA PRN 3. All 3 trials demonstrated ICS maintenance therapy provided better control of symptoms than ICS PRN Summary BUT, all 3 found similar rates of exacerbation between ICS maintenance therapy and ICS PRN 4. ICS PRN could be used in well-controlled mild persistent asthma in adolescents to limit ICS exposure and growth impairment References 1. National Asthma Education and Prevention Program. Expert Panel Report 3. Guidelines for the diagnosis and management of asthma. NHLBI National Asthma Education and Prevention Program. Expert Panel Report 3. Summary report: guidelines for the diagnosis and management of asthma. NHLBI Global Initiative for Asthma (GINA). GINA report, global strategy for asthma management and prevention Asthma: most recent asthma data. CDC Accessed January 4, 2019 Thomas 14

15 5. Asthma facts and figures. AAFA Accessed January 4, Lung procedures and tests: spirometry. American Lung Association Accessed January 10, Asthma control questionnaire (ACQ). American Thoracic Society Accessed January 10, Asthma quality of life questionnaire (AQLQ). American Thoracic Society Accessed January 10, ProAir HFA (albuterol) [prescribing information]. Horsham, PA: Teva Specialty Pharmaceuticals LLC; Jul ProAir RespiClick (albuterol) [prescribing information]. Horsham, PA: Teva Specialty Pharmaceuticals LLC; Aug Proventil HFA (albuterol [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp.; Dec Ventolin (albuterol) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; May Xopenex HFA (levalbuterol) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc; Feb Atrovent HFA (ipratropium) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals Inc; Aug Combivent Respimat (ipratropium bromide and albuterol) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; Jun Alvesco (ciclesonide) [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals; Mar Arnuity Ellipta (fluticasone furoate inhalation powder) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Jan Asmanex HFA (mometasone furoate) [prescribing information]. Whitehouse Station, NJ: Merck & Co; Mar Asmanex Twisthaler (mometasone furoate) [prescribing information]. Whitehouse Station, NJ: Merck & Co; Mar Flovent Diskus (fluticasone propionate inhalation powder) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Jan Flovent HFA (fluticasone propionate inhalation aerosol) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Jan Pulmicort Flexhaler (budesonide aerosol, powder) [prescribing information] Södertälje, Sweden: AstraZeneca; Oct Qvar RediHaler (beclomethasone) [prescribing information]. Frazer, PA: Teva Respiratory; Mar Serevent Diskus (salmeterol) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Dec Spiriva HandiHaler (tiotropium bromide) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; Feb Spiriva Respimat (tiotropium bromide) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; May Advair Diskus (fluticasone/salmeterol) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Jan Advair HFA (fluticasone/salmeterol) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Dec AirDuo RespiClick (fluticasone/salmeterol) [prescribing information]. Frazer, PA: Teva Respiratory, LLC; Mar Breo Ellipta (fluticasone/vilanterol) [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; Dec Dulera (mometasone/formoterol) [prescribing information]. Whitehouse Station, NJ: Merck and Co Inc; Jul Symbicort (budesonide/formoterol) [prescribing information]. Wilmington, DE: AstraZeneca LP; Dec Symbicort Turbuhaler (budesonide/formoterol) [product monograph]. Mississauga, Ontario, Canada: AstraZeneca Canada Inc; Oct Nelson HS, et al; SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006;129(1): Peters SP, et al. Serious asthma events with budesonide plus formoterol vs. budesonide alone. N Engl J Med. 2016;375(9): Singulair (montelukast) [prescribing information]. Whitehouse Station, NJ: Merck and Co; December Accolate [package insert]. Wilmington, DE: AstraZeneca; Nov Zyflo (zileuton) [prescribing information]. Cary, NC: Chiesi USA, Inc; May Zyflo CR (zileuton) [prescribing information]. Cary, NC: Chiesi USA, Inc; Dec Cromolyn Sodium (oral solution) [prescribing information]. Mason, OH: Prasco Laboratories; Dec Theophylline in 5% dextrose [package insert]. Bethlehem, PA: B. Braun Medial Inc; Jan Fasenra (benralizumab) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; Nov Nucala (mepolizumab) [product monograph]. Mississauga, Ontario, Canada: GlaxoSmithKline Inc; Jul Xolair (omalizumab) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; Sep Cinqair (reslizumab) [prescribing information]. Frazer, PA: Teva Respiratory; Jan Barnes CB, et al. Asthma and adherence to inhaled corticosteroids: current status and future perspectives. Respiratory Care. 2015;60(3): Chauhan BF, et al. Intermittent versus daily inhaled corticosteroids for persistent asthma in children and adults. Cochrane Database Syst Rev. 2013;(2):CD O Byrne PM, et al. Inhaled combined budesonide-formoterol as needed in mild asthma(sygma 1). N Engl J Med. 2018;378: Thomas 15

16 49. Bateman ED, et al. As-needed budesonide-formoterol versus maintenance budesonide in mild asthma (SYGMA 2). N Engl J Med. 2018;378: Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomized, double-blind, placebo-controlled trial. Lancet. 2011;377: Appendix A. Diagnosis tools a. Spirometry: assesses severity of obstruction and reversibility of obstruction 5 i. May be used in children > 5 years old ii. The following are recommended before and after taking SABA for diagnosis: 1. Forced expiratory volume in 1 second (FEV 1 ): volume of air a patient can exhale forcefully in one second a. Reduced value: significant obstruction b. Can help determine reversibility i. Increase of FEV 1 by > 12% from baseline ii. Increase of predicted FEV 1 by > 10% after inhalation of SABA 2. Forced expiratory volume in 6 seconds (FEV 6 ) [only used in adults] a. Reduced value: restricted breathing 3. Forced vital capacity (FVC): largest volume of air a patient can exhale forcefully a. Reduced value: restricted breathing 4. FEV 1 /FVC a. Increased value: restricted breathing b. Reduced value: obstructed breathing b. Patient Assessment Questionnaires 6-7 i. Asthma Control Questionnaire (ACQ) items: symptoms, rescue inhaler use, and FEV 1 % 2. 1-week recall 3. 7-point scale a. 0: no impairment b. 6: maximum impairment for symptoms and rescue use ii. Asthma Quality of Life Questionnaire (AQLQ) domains: symptoms, activity limitation, emotional function, and environmental exposure week recall 3. 7-point scale a. 1: severely impaired b. 7: no impairment Thomas 16

17 B. Classifications 1,2 Source: figure 14. Summary report Guidelines for the diagnosis and management of asthma. NHLBI C. GINA Stepwise management for patients > 12 years old 3 Thomas 17

18 D. Determining asthma control 1,2 Source: figure 15. Summary report Guidelines for the diagnosis and management of asthma. NHLBI E. Medications Table E-1: Asthma Inhalers Available in United States 9-35 Name Components Dosing Type of Inhaler Short-Acting Beta 2 Agonist (SABA) ProAir Albuterol sulfate 2 puffs every 4-6 MDI ProAir RespiClick hours PRN wheezing DPI Proventil or SOB MDI Ventolin MDI Xopenex Levalbuterol 2 puffs every 4 to 6 MDI hours PRN Short-Acting Anti-Muscarinic Agents (SAMA) Atrovent Ipratropium bromide 8 puffs every 20 MDI minutes PRN Combivent Respimat Ipratropium bromide + 8 puffs every 20 SMI albuterol sulfate minutes PRN Maintenance or Rescue Rescue Rescue Rescue* Rescue* Inhaled Corticosteroids (ICS) Alvesco Ciclesonide BID MDI Maintenance Arnuity Ellipta Fluticasone furoate QD DPI Maintenance Asmanex Mometasone furoate BID MDI Maintenance Asmanex Twisthaler QD or BID DPI Flovent Fluticasone propionate BID MDI Maintenance Flovent Diskus BID DPI Pulmicort Flexhaler Budesonide BID DPI Maintenance QVAR RediHaler Beclomethasone dipropionate BID MDI Maintenance Thomas 18

19 Long-Acting Beta 2 Agonist (LABA) Serevent Diskus Salmeterol xinafoate BID MDI Maintenance** Long-Acting Anti-Muscarinic Agent (LAMA) Spiriva Respimat Tiotropium bromide QD SMI Maintenance Spiriva HandiHaler QD MDI Combination: ICS + LABA Advair Fluticasone propionate + BID MDI Maintenance Advair Diskus salmeterol BID DPI Airduo RespiClick Fluticasone propionate + BID DPI Maintenance salmeterol Breo Ellipta Fluticasone furoate + QD DPI Maintenance vilanterol Dulera Mometasone furoate + BID MDI Maintenance formoterol fumarate Symbicort Turbuhaler Budesonide + formoterol fumarate QD or BID DPI Maintenance *Not recommended for rescue therapy outside the emergency room or urgent care settings; **Must be used with an ICS PRN: as needed; SOB: shortness of breath; MDI: metered-dose inhalers; DPI: dry powder inhaler; SMI: soft mist inhaler; QD: once daily; BID: twice daily Table E-2: Low, Medium, and High doses of ICS inhalers for patients > 12 years old 3,16-23 ICS Low Medium High Beclomethasone dipropionate (HFA) >400 Budesonide (DPI) >800 Ciclesonide (MDI) >320 Fluticasone furoate (DPI) 100 n/a 200 Fluticasone propionate (MDI, DPI) >500 Mometasone furoate (MDI, DPI) >440 MDI: metered-dose inhalers; DPI: dry powder inhaler F. Exacerbation risk factors 1-3 Severe airflow obstruction Persistent airflow obstruction > 2 ED visits or hospitalizations for asthma in last year History of intubation or intensive care units admissions in last 5 years Feeling in danger or frightened by asthma Female Nonwhite Current tobacco smoker Not using ICS Depression Increased stress Socio economic factors Attitudes and beliefs about medications Thomas 19

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