Individualizing and Optimizing Asthma Care. CFW 2018 Friday, April 13, 9:45 11:15 am Renaissance Austin Hotel in Austin, Texas

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Individualizing and Optimizing Asthma Care CFW 2018 Friday, April 13, 9:45 11:15 am Renaissance Austin Hotel in Austin, Texas

Speaker Disclosure Dr. Hawkins has disclosed that he has no actual or potential conflict of interest in relation to this topic.

Objectives By completing this educational activity, the participant should be better able to: 1. Discuss the components of pulmonary function tests, indications, and interpretation of spirometry. 2. Accurately diagnose asthma and be able to differentiate the appropriate disease severity classification for each patient. 3. Appreciate the role of various medical therapies in the management of asthma and demonstrate the ability to adjust therapy as indicated to attain the best disease control in the asthma patient. 4. Provide patients practical tools for self management.

Children with Asthma Self limited wheezing illness in early childhood Some persist through adulthood Difficult to diagnose under age 6 Improvement: 12 month exacerbations declined from about 62 percent in 2001 to about 54 percent in 2016. Vital Signs: Asthma in Children United States, 2001 2016 MMWR Weekly / February 9, 2018 / 67(5);149 155

# 1. Pulmonary Function Testing SPIROMETRY Objective Measurement of Lung Function Pulmonary function tests Indications for Spirometry Diagnosis of airflow limitation Severity of Obstruction Response to Therapy Goal is to give enough medications to achieve normal lung function

ARS Question 1 1. I do not have an office Spirometer. 2. I have one but do not feel confident using it. 3. I have one and feel confident but don t have time/workflow. 4. I have one, I feel confident, but don t use it and feel guilty.

Coding and Reimbursement Procedure CPT Code Reimbursement* Single Spirometry 94010 $32.82 Pre post Spirometry 94060 $57.71 Pulmonary stress test simple 94620 $71.77 Medication administration bronchodilator supply separate 94640 $13.34 Demonstration / instruction 94664 $14.79 Smoking Cessation <8x/ yr 99406 $12.98 Equipment Cost Office Spirometer $1,500 2,500

Coding and Reimbursement Tests /week (#) Reimbursement/year* ROI $1,995 in weeks 4 $6,864 15 6 $10, 296 10 8 $13,728 7 10 $17,160 6 15 $25,740 4 20 $34,320 3 25 $42,900 2 *Based upon CPT code 94010 ESTIMATED RETURN ON INVESTMENT

Coding and Reimbursement Diagnosis Code Cough (smokers) J41.0 Simple chronic bronchitis J42 Mucopurulent chronic bronchitis J41.1 Acute bronchitis J20.9 Chronic obstructive pulmonary J44.9 disease Shortness of breath R06.02 Restrictive lung disease (other diseases.) Asthma 518.89 J45

Three Numbers FVC: Forced Vital Capacity FEV1: Amount breathed out in 1 second FEV1/FVC: How much of your lung s air can be exhaled in the first second Measure of caliber or function of airway NOT A COMPARISON TO REFERENCE VALUES More accurate than Peak Flow

Lung Volumes ERV + RV = Functional Residual Capacity Inspiratory Capacity Vital Capacity Tidal Volume Expiratory Reserve Volume Residual Volume

OBSTRUCTION? FEV1/FVC 70 Overestimates COPD diagnosis in elderly Underestimates COPD diagnosis in those under age 45

Severity of Obstruction FEV1 % of predicted Mild >80 Moderate 50 to 79 Severe 30 to 49 Very severe <30 * Severity of Restriction FVC % of predicted Mild >65 to 80 Moderate >50 to 64 Severe <50

FEV1 Thresholds Grade 1: Mild FEV1 > 80% Grade 2: Moderate 50% < FEV1 < 80% Grade 3: Severe 30% < FEV1 < 50% Grade 4: Very Severe FEV1 < 30%

Normal Flow Volume Curve (Expiratory) 12 10 PEFR 8 Flow (L/sec) 6 4 FEV 1 2 0 0 1 2 3 4 5 6 Volume (L)

Normal, Obstructed, & Restrictive Curves 1 2 1 0 8 Normal Obstruction Restriction Flow (L/sec) 6 4 2 0 0 1 2 3 4 5 6 Volume (L)

Maximal Forced Expiratory Maneuver Public Health Image Library, (PHIL), #20950, Veronica Burkel, M.P.H., 2013, http://phil.cdc.gov/phil/details.asp accessed 8/11/16, public domain

Public Health Image Library, (PHIL), # 19298, Daniel A. Singer, MD, MPH, Medical Officer 2014 http://phil.cdc.gov/phil/details.asp accessed 8/11/16, public domain Coaching Blow, Blow, Blow!

Inspiratory Volume Loop Expiratory Flattened Inspiratory Loop Indicating possible Extrathoracic Obstruction

Is FEV 1 / FVC Ratio Low? (<70%) Yes Obstructive Defect Is FVC Low? (<80% pred) Yes Combined Defect of Obstruction and Restriction /or Hyperinflation No Pure Obstruction Reversible Obstruction with ß agonist Reversible Obstruction and improved FVC with ß agonist Adapted with permission from J S Lowry No Further Testing with Full PFT s Yes Yes Suspect Asthma No Suspect COPD

Common Obstructive Disorders Diffuse Airway Disease Asthma COPD Bronchiectasis Cystic Fibrosis Upper Airway Obstruction Foreign Body Neoplasm Tracheal Stenosis Tracheomalacia Vocal Cord Paralysis

Is FEV 1 / FVC Ratio Low? (<70%) Diagnostic Flow Diagram, Restriction No Is FVC Low? (<80% pred) Yes No Restrictive Defect Normal Spirometry Further Testing with Full PFT s and consider referral

Common Restrictive Disorders Parenchymal Interstitial Lung Diseases Fibrosis Granulomatosis (TB) Pneumoconiosis Pneumonitis (lupus) Loss of Functioning Tissue Atelectasis Large Neoplasm Resection Pleural Effusion Fibrosis Chest Wall Kyphoscoliosis Neuromuscular Disease Trauma Extrathoracic Abdominal Distension Obesity

Asthma or COPD? Underlying immune mechanism of chronic inflammation different Age of onset Earlier in life with asthma Usually > age 40 in COPD Symptoms in asthma vary; COPD slowly progressive Smoking associated with COPD Asthma with reversible airflow limitation; irreversible airflow limitation in COPD Allergic Symptoms with Asthma

Case # 1: Rachel 58 yo Woman Previous visits for acute bronchitis treated with antibiotics Half a pack/day for 20 years (10 pk. Yrs.) Grew up in family of smokers Worsening x 3 months Complains of SOB when walking up stairs Wheezing waking her at night and productive cough

Case #1: Rachel Spirometry Results Flow (L/sec) 12 8 4 Age: 58 Height: 160 cm Sex: Female Ethnicity: Caucasian Pre bronchodilator Post bronchodilator 0 0 2 4 Volume (L) 6

Case #1: Rachel Spirometry Results Pre Bronchodilator Post Bronchodilator Predicted Measured % Predicted Measured % Change FVC 4.37 L 4.65 L 106% 4.65 L 0% FEV 1 3.78 L 2.98 L 79% 3.19 L 7% FEV 1/ FVC (%) 86% 64% 69% Office Staff eager to leave at end of day and only waited 5 minutes before tests

Case #1: Rachel Spirometry Results Pre Bronchodilator Post Bronchodilator Predicted Measured % Predicted Measured % Change FVC 4.37 L 4.65 L 106% 4.65 L 0% FEV 1 3.78 L 2.98 L 79% 3.50 L 17.5% FEV 1/ FVC (%) 86% 64% 75% After waiting the full 20 minutes.

ARS Question 2 Case #1: Rachel Diagnosis 1. Mild Intermittent Asthma 2. Reversible Airways Disease 3. Mild Persistent Asthma 4. Mild COPD

Spirometry Technique Forced expiratory maneuver Coach patient to get a maximal effort Six seconds of effort required though most of air pushed out in the first second Pace of expired air is most important variable; therefore it should be released with explosive force 4 MDI of 100 ug Albuterol preferably with a spacer Wait 20 minutes for full effect

CASE #2: Julie History 39 year old woman Smoker ++Extrinsic allergies SOBOE with white sputum x 1 week (Technique?)

CASE #2: JULIE More HISTORY 3 visits to the ER in previous 2 days No previous measure of airflow (i.e. PEFR or Spirometry) Treated with Antibiotics Little improvement Family history is positive for asthma

CASE #2: JULIE SPIROMETRY RESULTS 12 10 8 Pre Post Flow (L/sec) 6 4 2 0 0 1 2 3 4 5 6 Volume (L)

Case #2: Julie Simplified Spirometry Pre Bronchodilator Post Bronchodilator Measured % Measured % % change FVC 1.75 49 2.50 63 43 FEV1 1.10 39 1.50 68 36 FEV1/ FVC 63% 60 0.4 = 400 cc improvement

Definition of Reversibility Pre Bronchodilator Post Bronchodilator FEV 1 / FVC below 70% 12% and at least 200cc Reversibility = Asthma!

ARS Question 3 Case #2: Julie What is her diagnosis? 1. Mild Intermittent Asthma 2. Mild Persistent Asthma 3. Moderate Persistent Asthma 4. Severe Persistent Asthma 5. Mild COPD

Case #2: Julie Explanation Although she is a smoker she changes after bronchodilator by 36% and 400 cc, therefore she has reversible airways disease or ASTHMA She needs Anti inflammatory therapy After bronchodilation she has a persisting obstruction and restriction so we would need to reassess her after three months of asthma therapy. Moderate persistent asthma because FEV is <80% of predicted

Case #2: Julie Explanation (Restriction) Restriction due to Air Trapping Lungs are full and can t take any more Not enough air getting in or out Could be from lungs too full? Air Trapping Could be from lungs not getting full enough? Chest wall, or pleural restriction?

Measurement Thresholds Severity of Obstruction FEV1 % of predicted Mild >80 Moderate 50 to 79 Severe 30 to 49 Very severe <30 * Severity of Restriction FVC % of predicted Mild >65 to 80 Moderate >50 to 64 Severe <50

2. Asthma Diagnosis and Stratification, (Severity) Separate patients with minor illness from major illness Appropriately deploy medications Prevent Ambulatory Sensitive Hospitalizations

Rule of 2s Is the Asthma Persistent? Is there Ongoing Inflammation? Take a quick relief (rescue) inhaler (like albuterol) for problems more than 2 times a week Awaken at night with asthma problems more than 2 times a month Refill a quick relief inhaler more than 2 times a year Persistent Asthma: Therefore need a controller medication

NHLBI Disease Severity Mild Intermittent Asthma (ICD 10 = J45.20) No air flow limitation between episodes of asthma Low risk Low functional limitation Persistent Asthma (ongoing inflammation) Mild Persistent Moderate Persistent Severe Persistent

NHLBI: 2007 https://www.nhlbi.nih.gov/sites/default/files/media/docs/asthgdln_1.pdf table 2.2 accessed March 10, 2018

Limitations to Grading Severity Four grades split at 80%, 50% and 30% of predicted value Measuring Airway function doesn t always predict disease trajectory (prognosis)? Therefore Combine with Dyspnea & Exacerbation Frequency to choose treatment regimen

3. Therapy: NHLBI Stepped Care Mild Persistent Moderate Persistent Severe Persistent

Medication Types ICS Inhaled Corticosteroid SABA Short Acting Beta Agonist LABA Long Acting Beta Agonist SAMA Short Acting Anti muscarinic (Anticholinergic) LAMA Long Acting Anti muscarinic LTRA Leukotriene Receptor Antagonist Monoclonal Antibody Omalizumab

MDI (Metered Dose Inhalers) Small and large particles of medication delivered by a propellant, formerly CFC, then HFA since 2007 Improved delivery with spacer to remove large particles Avoids 20 min of nebulization and especially B agonist side effects: anxiety, tremor Covered by Medicare D (Medicare B covers nebulizers)

Spacer = Nebulizer with Less S/E

Dry Powder Inhalers Smaller Particles More distal delivery in tracheo bronchial tree Less excess medication in GI tract Therefore less side effects However some patients feel they don t get the Kick that they feel from a SABA Need encouragement and coaching Need to know about daily use not prn

Long Acting Beta Agonists (LABA) SERAVENT Diskus, (salmeterol) DPI device (FDA approved for Asthma > 4y and EIB) FORADIL Aerolizer, (formoterol) (FDA approved for Asthma > 5 y as add on to longterm control med) BROVANA, arformoteral neb (not FDA approved for Asthma) PERFORMIST, (salmeterol) Neb (Not FDA approved for Asthma) STRIVERDI Respimat, (olodaterol) DPI device (not FDA approved for Asthma) ARCAPTA Neohaler, (indacaterol) (not FDA approved for Asthma) Fanta C, Drug Therapy: Asthma N Engl J Med 2009;360:1002 14

Inhaled Corticosteroid, ICS FLOVENT MDI or Diskus (44, 110, 220 fluticasone) DPI Device (FDA approved >4 y asthma) QVAR MDI (40 & 80 beclomethasone) HFA MDI (FDA Asthma > 4y asthma) ASMANEX Twisthaler (110 4 12y, 220 >12y) (FDA approved > 4 y, asthma) PULMICORT Tubohaler, (200 budesonide) (DPI Device) (FDA 6 y asthma) PULMICORT Flexhaler, (90 & 180 budesonide) DPI Device FDA > 6) PULMICORT Respules (budesonide) Neb bid (FDA > 6) AEROSPAN Aerosol, (80 & 160 flunisolide) HFA MDI (FDA > 6 y) ALVESCO Aerosol, (80 & 160 ciclesonide) HFA MDI (FDA approved >12 y asthma) ASMANEX HFA MDI, (100 & 200 mometasone) DPI (FDA approved > 12 y Asthma) ARNUITY Ellipta, (100 & 200 fluticasone) DPI device FDA >12

Combo LABA & ICS ADVAIR Diskus, salmeterol & fluticasone, 250/50, (125/50, 500/ 50) (45/21 115/21 230/21 bid MDI) FDA approved 2000 Asthma >12y) SYMBICORT, formoterol & budesonide) (80/45, 160/45 (FDA approved for Asthma >12) BREO Ellipta, daily (vilanterol & fluticasone) (FDA approved in Asthma > 18y) DULERA Aerosol, (100/5 and 200/5 ii bid (formoterol & mometasone) (FDA >12 y 2010)

Anticholinergic LAMA SPIRIVA Handihaler or Respimat, tiotropium DPI (FDA approved Respimat 1.25 mcg for uncontrolled asthma in patients aged 6 years on ICS or ICS + LABA) not 2.5 Respimat INCRUSE Ellipta, (umeclidinium) DPI (Not FDA approved for Asthma) SEEBRI Neohaler, (glycopyrrolate) DPI (Not FDA approved for Asthma)

LAMA & LABA NOT approved for Asthma by FDA ANORO Ellipta (umeclidinium & vilanterol) (not FDA approved for Asthma) STIOLTO Respimat (tiotropium & olodaterol) (Not FDA approved for Asthma) UTIBRON Neohaler (glycopyrrolate & indacaterol) (Not FDA approved for Asthma) BEVESPI Aerosphere (formoterol & glycopyrrolate) Not FDI approved for asthma)

ICS, LAMA, LABA? Trelegy: Fluticasone, Umeclidinium, vilanterol Not FDA approved for Asthma

4. Self Management Tools Peak Flow Meters Good to dx or refute asthma with exercise Good to diagnose occupational Asthma Good to monitor response Asthma Action Plan

Exercise Induced Bronchospasm (EIB) This is not asthma ICS don t help Must be differentiated from Exercise worsening moderate persistent asthma SABA or LAMA Salmeterol or Formoterol no more than twice daily

Occupational Asthma High Molecular Weight Sensitization (>10kD) Protein or glycopeptide, usually with rhinosinusitis symptoms Animals, cereals & grains, fungi, plant products (latex) Low Molecular Weight Sensitization Diisocyanetes (polyurethane foams etc.) Wood dusts, platinum salts, phenol formaldehyde, antibiotic inhalation (pharmacists) Irritant Exposure (i.e. 9/11 World Trade Center) alkaline dust New onset after high level exposure (16% of those exposed, and after 9 y only 40% of those recovered) Tarlo & Lemiere Occupational Asthma NEJM 370(7) Feb 13, 2014

Peak Flow Meter Encourages self awareness Concept of Personal Best Also helpful to diagnose E.I.B and Occupational Asthma

NHLBI Asthma Action Plan

Zones Green Zone (more than L/min [80 percent of your personal best number]) good control. Yellow Zone (between L/min and L/min [50 to less than 80 percent of your personal best number]) caution take an inhaled SABA. Increase daily medicines. Red Zone (below L/min [less than 50 percent of your personal best number]) signals a medical alert. Inhaled SABA (quick relief medicine) right away. Urgent medical attention, for treatment of exacerbation or step up care

Environment: Dust Mites Encase your mattress & Pillow in a special dust mite proof cover. Or wash the pillow each week in hot water. Water must be hotter than 130 F to kill the mites. (Cooler water used with detergent and bleach can also be effective.) Wash the sheets and blankets on your bed each week in hot water.

Other Strategies Which Mite Help Reduce indoor humidity to or below 60 percent; ideally 30 50 percent. Dehumidifiers or central air conditioners can do this. Try not to sleep or lie on cloth covered cushions or furniture. Remove carpets from your bedroom and those laid on concrete Keep stuffed toys out of the bed, or wash the toys weekly in hot water or in cooler water with detergent and bleach. Placing toys weekly in a dryer or freezer may help. Prolonged exposure to dry heat or freezing can kill mites but does not remove allergen.

Other Self care Particle Awareness in Atmosphere Ozone Index Influenza vaccination Pneumococcal vaccination Smoking Cessation

Readiness to Quit Caring Messages at every visit Evidence shows FPs are effective It takes 6 attempts for many people, don t give up

Smoking Cessation Ask, Advise, Assess, Assist, Arrange Only intervention to affect natural history Pharmacological Nicotine Replacement E cigarettes?, not likely an effective substitute Bupropion Varenicline

Summary Diagnose Wheezing illness by symptoms < 6 y Diagnose using Spirometry and goal is to achieve normal lung function (evaluate q 3 m) Intervene with Environmental Factors Vaccinate with Influenza & PCV 23 >19y Smoking Cessation and avoid ETS