Faculty Presenters. Leonard M. Fromer, MD Executive Medical Director Group Practice Forum Los Angeles, California

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2 Faculty Presenters Leonard M. Fromer, MD Executive Medical Director Group Practice Forum Los Angeles, California Frank C. Sciurba, MD Associate Professor of Medicine Medical Director, Pulmonary Physiology Laboratory, Division of Pulmonary, Allergy and Critical Care Medicine University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania

3 Disclosures Leonard M. Fromer, MD Consultant Mylan Speakers Bureau Boehringer Ingelheim Frank C. Sciurba, MD Research Support AstraZeneca, Boehringer Ingelheim, Commonwealth of Pennsylvania, COPD Foundation, GlaxoSmithKline, National Institutes of Health (NIH), PneumRx, Pulmonx, Respironics Scientific Advisory Board GlaxoSmithKline, Boehringer Ingelheim

4 Learning Objectives Recognize risk factors and early symptoms of COPD Summarize the current clinical guidelines for the optimal management of COPD Devise a treatment plan for COPD patients that includes the appropriate use of bronchodilators Evaluate inhaler use among COPD patients

5 Definition and Early Symptoms of COPD Common, preventable, treatable disease characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities caused by significant exposure to noxious particles or gases 1 Umbrella term for progressive lung diseases, including 2 Emphysema Chronic bronchitis Refractory (nonreversible) asthma/asthma COPD overlap syndrome Some forms of bronchiectasis Most common early symptoms 3 Dyspnea on exertion Chronic cough Abnormal sputum production 1 Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/ 2 COPD Foundation. is COPD/Understanding COPD/What is COPD.aspx 3 Fromer L. Intern J Gen Med. 2011;4:

6 Epidemiology of COPD United States 1,2 Third leading cause of death Number affected: 13.7 million Age adjusted prevalence among individuals 25 y: 6.5% Now affects more women than men Incidence is increasing among younger individuals (ages 45 64) Worldwide 3,4 Fourth leading cause of death Number affected: 384 million Prevalence among individuals 30 y: 11.4% Prevalence is expected to increase with increasing prevalence of smoking in developing countries and increasing age of populations in high income countries 1 Ford ES et al. CHEST. 2013:144: Kochanek D, et al. Natl Vital Stat Rep. 2016;65 (4). 3 Adeloye D, et al. J Global Health : World Health Organization.

7 COPD Deaths by Gender, CDC. NVSR, Modified from the American Lung Association Disparities in Lung Health. Taking Her Breath Away initiatives/research/lung health disparities/the rise of copd in women.html?referrer=

8 Etiology and Pathophysiology of COPD ETIOLOGY/RISK FACTORS Environmental factors Smoking Pollutants/particle exposure Host factors Genetics Age Gender Lung growth and development Socioeconomic status Asthma/airway hyperreactivity Chronic bronchitis Infections PATHOGENESIS Oxidative stress Protease/antiprotea se imbalance Amplified inflammation Inflammatory mediators Inflammatory cells Fibrosis Peribronchiolar Interstitial PATHOPHYSIOLOGY Airflow limitation Gas trapping Gas exchange abnormalities Mucus hypersecretion Exacerbations Deconditioning Pulmonary hypertension (late stage) Comorbidities

9 The Inactivity Dyspnea Spiral Respiratory impairment Further abstention Dyspnea during mild exertion Further deconditioning Homebound, depression, O 2 therapy, etc Dyspnea during ADL Dyspnea during moderate exertion Abstinence from exercise ADL, activities of daily living. Physical deconditioning Adapted from Denis O Donnell, MD.

10 Comorbidities are Common in COPD Sleep Apnea Lung Cancer Emphysema Anxiety, Depression Pulmonary Hypertension Anemia Cardiovascular Disease Peripheral Muscle Wasting & Dysfunction Osteoporosis Diabetes Metabolic Syndrome Peptic Ulcers GI complications Cachexia Adapted from Kao C et al. Atlas of COPD Barnes PJ et al. Eur Respir J. 2009;33: Fishman A et al. N Engl J Med. 2003;348:

11 COPD and Cardiac Disease: A Common Combination PHC4 provided hospital discharges between Oct. 1, 2007 and Sept. 30, 2008 (n=408,924) 1 COPD: N=57,289 CHF: N=61,475 COPD only N=28,916 COPD + CHF N=8,868 COPD, CHF, CAD N=7,749 CHF only N=23,621 CAD: N=94,699 COPD + CAD N=11,756 CHF, congestive heart failure; CAD, coronary artery disease. CAD only N=53,957 CHF + CAD N=21, % of COPD discharges have comorbid CHF and/or CAD 1 COPD is an independent risk factor for cardiovascular disease mortality 2 1 Pittsburgh Regional Health Initiative Courtesy of Brian W. Carlin, MD. 2 Finkelstein J, et al. J COPD. 2009;4:

12 Case 1: Burt J. Burt is a 42 y o IT specialist who recently quit smoking (2 pk/d habit from age y). He is in the office for a routine checkup. All vitals are normal except for slightly elevated blood pressure. He is 6 tall and weighs 205 lbs. He reports ongoing fatigue that he attributes to recovering from a chest cold. Recent medical history is significant for 2 episodes of acute bronchitis, 1 and 2 years previous.

13 Case 1: Question Should Burt be screened for COPD? 1. Only if he reports dyspnea 2. No, because there is no evidence of cough 3. Yes, because he is a former smoker 4. No, because he is too young to have COPD

14 The Argument for Selective Screening: The COPD Population Screener 1. During the past 4 weeks, how much of the time did you feel short of breath? None of the time A little of the time Some of the time Most of the time Do you ever cough up any stuff, such as mucus or phlegm? No, never Only with Yes, a few days a Yes, most days of occasional colds or month the week chest infections Please select the answer that best describes you in the past 12 months. I do less than I used to because of my breathing problems. Strongly disagree Disagree Unsure Agree Have you smoked at least 100 cigarettes in your ENTIRE LIFE? No Yes How old are you? Age years 0 Age years 1 Age years 2 All of the time 2 Yes, every day 2 Strongly Agree Don t know 0 2 Age 70+ years 2 COPD Foundation. Martinez FJ, et al. COPD. 2008;5:85 95.

15 Indicators for Pursuing a Diagnosis of COPD Dyspnea that is persistent, progressive over time, worse with exercise Patients may avoid exertion, so ask how are you doing? AND what are you doing? Chronic cough Intermittent Recurrent wheezing/chest tightness Productive or unproductive Chronic sputum production Recurrent lower respiratory tract infections History of risk factors such as smoking, indoor air pollution, occupational particle exposure Family history of COPD and/or childhood factors, eg, low birth weight, childhood respiratory infections Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

16 High Index of Suspicion for COPD Screening and Diagnosis Consider COPD in patients with any symptoms and history of exposure to risk factors SYMPTOMS Shortness of breath Chronic cough Sputum RISK FACTORS Host factors Tobacco smoke Occupation Indoor/outdoor air pollution Spirometry is required to make diagnosis Post bronchodilator FEV 1 /FVC <0.70 confirms presence of persistent airflow limitation * *Post bronchodilator FEV 1 /FVC measured min after 2 4 puffs of a short acting bronchodilator. FEV 1, forced expired volume in 1 second; FVC, forced vital capacity. Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

17 Diagnosis: Medical History Smoking Past medical history, e.g., asthma, allergy, respiratory infections in childhood, chronic respiratory/nonrespiratory illnesses Family history of COPD or other chronic respiratory illnesses Patterns of symptom development History of exacerbations or hospitalizations for respiratory illnesses Presence of comorbidities, eg, heart disease, osteoporosis, other conditions that may restrict activity Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

18 Misdiagnoses and Missed Diagnoses 50% of patients with COPD may be misdiagnosed or undiagnosed 1 Contributing factors 2 Lack of awareness of early symptoms Acceptance of symptoms as a consequence of smoking or aging among the general population Symptomatic similarities to asthma Failure of health care providers to use spirometry for diagnosis Potential impact 2 No treatment, inadequate treatment, or inappropriate treatment Unchecked disease progression and rate of decline, with increased frequency/severity of exacerbations and increased hospitalizations Loss of lung function Reduced quality of life Younger age at death 1 Wise RA, et al. Am J Med. 2007;120(8 Suppl 1):S14 S22. 2 Fromer L. Int J Gen Med. 2011;4:

19 Gender Bias: COPD is Less Likely to be Diagnosed in Women Hypothetical Male Patient With COPD Symptoms: Diagnosed as COPD by 65% of physicians Hypothetical Female Patient With Identical COPD Symptoms: Diagnosed as COPD by 49% of physicians COPD symptoms in women are most commonly misdiagnosed as asthma Chapman KR, et al. Chest. 2001;119:

20 Spirometry Incorporate procedure into clinic workflow for appropriate patients Most reproducible/objective measurement of airflow limitation Critical for Confirming diagnosis Assessing prognosis Monitoring response to treatment and treatment adjustments Identifying rapid decline Accuracy depends on appropriate preparation, bronchodilation, technician coaching/patient effort Consider other diagnoses when symptoms are disproportionate to degree of airflow obstruction Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

21 Spirometry: Range of Severity Volume (L) FEV 1 FVC Normal Mild Obstructive Disease Severe Obstructive Disease Time (Seconds)

22 GOLD Refined Combined COPD Assessment Diagnosis Confirmed by Spirometry Postbronchodilator FEV 1 /FVC < 0.7 Assessment of Airflow Limitation GOLD Level FEV 1 (% Predicted) 1 Mild 80 2 Moderate Severe Very Severe < 30 Exacerbation History 2 or 1 leading to hospitalization 0 or 1 not leading to hospitalization Assessment of Symptoms and Risk of Exacerbations C A mmrc 0 1 CAT < 10 D B mmrc 2 CAT 2 Symptoms FEV 1, Forced expiratory volume in 1 second; FVC, forced vital capacity; mmrc, Modified British Research Council Questionnaire; CAT, COPD Assessment Test. Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

23 Asthma COPD Overlap Syndrome Proposed Diagnostic Criteria Major Criteria Marked reversibility with bronchodilators (>15% and >400 ml in FEV 1 ) History of asthma (<40 years of age) Sputum/blood eosinophilia Minor Criteria Reversibility on 2 separate occasions (>12% and >200 ml in FEV 1 ) History of atopy Increased total serum IgE FEV 1, Forced expiratory volume in 1 second. Overlap syndrome: 2 major criteria OR 1 major + 2 minor criteria Soler Cataluña JJ et al. Arch Bronconeumol. 2012;48: Miravitlles M, et al. Arch Bronconeumol. 2014;50:1 16.

24 Does Early Diagnosis Improve Outcomes? FEV 1 (L) Smoking Cessation Slows Lung Function Decline in Mild COPD: Lung Health Study at 11 Years Sustained Quitters Intermittent Quitters Continuous Smokers Year Smoking cessation even at early stages of disease slows the decline of lung function. Does early detection of COPD with spirometry increase likelihood of smoking cessation? Figure adapted from Anthonisen NR, et al. Am J Respir Crit Care Med. 2002;166: Calverley et al. Lancet. 2003;362: BMJ Publishing Group.

25 Guidelines for Intervention and Treatment Multiple guidelines available worldwide Global Strategy for Diagnosis, Management, and Prevention of COPD (GOLD Report 2017) 1 ACP/CHEST/ATS/ERS Clinical Practice Guideline: Diagnosis and Management of Stable COPD, Therapeutic recommendations vary; insufficient guidance on use of newer combination therapies 3 ACP, American College of Physicians; CHEST, American College of Chest Physicians; ATS, American Thoracic Society; ERS, European Respiratory Society. 1 Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/ 2 Qaseem A, et al. Ann Intern Med. 2011;155: Han MK, et al. Lancet Respir Med. 2016; 4:

26 Management of COPD: Focus on Prevention and Maintenance Nonpharmacologic interventions Smoking cessation Vaccination (flu and pneumococcal vaccines) Avoidance of indoor/outdoor air pollution Reduce occupational exposure to irritants Physical activity/exercise training Pulmonary rehabilitation Pharmacologic therapy Bronchodilators Antimuscarinic agents Methylxanthines* Corticosteroids Phosphodiesterase 4 inhibitors *Use in COPD is controversial. Goals of therapy Reduce/relieve symptoms Reduce impairment Reduce risk of exacerbations Reduce frequency/severity of exacerbations Decrease long term lung function decline Increase exercise tolerance Reduce hospitalizations and mortality Improve health status and health related quality of life Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/. Qaseem A, et al. Ann Int Med. 2011;155:

27 Nonpharmacologic Interventions GOLD Patient Group A B, C, D Essential Smoking cessation Smoking cessation Pulmonary rehabilitation Recommended Physical activity Physical activity Depends on local guidelines Influenza vaccine Influenza vaccine Pneumococcal vaccine Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

28 Pulmonary Rehabilitation Efficacious, cost effective intervention for improving functional performance, quality of life and decreasing health care utilization in patients with COPD Components Exercise/physical activity training Education/psychosocial support Programs are underused < 2% of patients with COPD have participated in pulmonary rehabilitation Many factors contribute to underuse, eg, health system, physician, and patientrelated factors Coultas D, et al. Clin Pulm Med. 2009;16(4):

29 Pharmacologic Interventions: GOLD Grades A and B Group A Continue, stop, or try alternate class of bronchodilator Group B LAMA + LABA Evaluate Effect Persistent Symptoms * Bronchodilator *Preferred treatment. LAMA, long acting antimuscarinic agent; LABA, long acting 2 adrenergic agent. Long Acting Bronchodilator Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

30 Pharmacologic Interventions: GOLD Grades C and D LAMA + LABA Group C LABA + ICS Consider roflumilast if FEV 1 <50% predicted + chronic bronchitis Group D Consider macrolide in former smokers Further exacerbation(s) * LAMA Further exacerbation(s) LAMA Further exacerbation(s) LAMA +LABA +ICS * LAMA + LABA *Preferred treatment. LAMA, long acting antimuscarinic agent; LABA, long acting 2 adrenergic agent; ICS, inhaled corticosteroid. Persistent symptoms or further exacerbation(s) LABA + ICS Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

31 Pharmacologic Options in COPD Bronchodilators Anti Inflammatory Short Acting Anticholinergic (SAMA): Ipratropium agonists (SABA): Albuterol Levalbuterol Metaproterenol SAMA + SABA: Ipratropium + albuterol Long Acting Anticholinergic (LAMA): Tiotropium Aclidinium (BID) Umeclidinium agonists (LABA) Salmeterol (BID) Formoterol (BID, nebulized) Arformoterol (BID, nebulized) Indacaterol (QD) Olodaterol (QD) LAMA + LABA Umeclidinium + vilanterol Tiotropium + olodaterol Indacaterol + glycopyrrolate (BID) Theophylline (pill) ICS + LABA Fluticasone + salmeterol (bid) Budesonide + formoterol (bid) Fluticasone + vilanterol (qd) PDE 4 inhibitors Roflumilast (pill) Oral steroids Prednisone* Methylprednisolone* *Not FDA approved for use in COPD specifically. SAMA, short acting antimuscarinic agent; SABA, short acting 2 adrenergic agent; LAMA, long acting antimuscarinic agent; LABA, long acting 2 adrenergic agent; ICS, inhaled corticosteroid; PDE 4, phosphodiesterase 4.

32 LABA/ICS vs. LAMA/LABA: FLAME Trial SGRQ C, St. George's Respiratory Questionnaire. Trough FEV 1 and SGRQ C symptom scale were significantly greater in the LABA/LAMA vs the LABA/ICS group From N Engl J Med., Wedzicha, Banerji, Chapman, et al, Indacaterol Glycopyrronium versus Salmeterol Fluticasone for COPD, 374: Copyright 2016 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

33 Wisdom Trial: Withdrawal of ICS in Patients * on LAMA/LABA Long acting Bronchodilators *Pa ents with severe COPD; Tiotropium + salmeterol. From N Engl J Med., Magnussen, Disse, Rodriguez Roisin, et al, Withdrawal of Inhaled Glucocorticoids and Exacerbations of COPD, 371: Copyright 2014 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

34 Types of Inhalers Used in COPD Inhaler Type Metered dose Inhalers Pressurized (pmdis) Breath actuated (BA MDIs) Dry Powder Inhalers (DPIs) Soft Mist Inhalers (SMIs) Nebulizers Key Characteristics Short and long acting bronchodilators and combinations Require use of breath actuation technique Can be used with a spacer or holding chamber Suitable for most COPD patients capable of needed breathing control May not be suitable for elderly, confused, or those with hand conditions (e.g., arthritis) Long acting bronchodilators and combinations Breath actuated delivery Require adequate peak respiratory flow Tiotropium; ipratropium albuterol combination Useful for patients with low dexterity Generate a soft, slower moving aerosol plume Require use of breath actuation technique (less so than MDI) Short and long acting bronchodilators Optimal for patients with cognitive or physical barriers to inhaler use May be appropriate for treatment of exacerbations Garvey C, et al. Advance Healthcare Network for NPs and PAs. Posted at practitioners and physicianassistants.advanceweb.com/archives/article Archives/Toward Better COPD Management.aspx on August 8, 2011.

35 Monitoring Treatment Lung function assessments FEV 1 assessed by spirometry Functional capacity assessed by timed walking test Oxygenation at rest using an arterial blood gas sample Symptoms Cough Sputum production/color Dyspnea Change in lung function Fatigue Activity limitation Sleep disturbance Weight loss Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

36 Monitoring Treatment (Cont.) Inquire about Exacerbations: frequency, severity, likely causes Urgent care visits and hospitalizations (including duration of stay and need for mechanical ventilation Smoking status/exposure to smoking Pharmacotherapy Doses of current medications Adherence to treatment regimen Effectiveness of treatment regimen Inhaler technique: CHECK and REVIEW AT EVERY FOLLOW UP APPOINTMENT Side effects of treatment Request imaging Worsening symptoms Exacerbations with purulent sputum Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

37 Case 2: Sandy L. Sandy is a 58 y o former smoker with moderate COPD. She was doing well until recently on combination LAMA + LABA treatment, but she now reports that her symptoms have been increasing, and last month she experienced an exacerbation that sent her to the ED. She was not hospitalized, but she worries that she will be.

38 Case 2: Question Which of the following would be the next step in bringing Sandy s COPD back under control? 1. Revisit her inhaler technique 2. Restage her COPD 3. Switch to a different LABA + LAMA combination 4. Switch to triple therapy with LABA + LAMA + ICS

39 Adherence to Inhaler Therapy in COPD Nonadherence to COPD medications is high 49% do not use inhaled medications as prescribed 31% use ineffective inhaler dosing techniques 50% overuse medications during periods of respiratory distress Factors predicting nonadherence Intentional nonadherence: deliberate discontinuation during periods of symptom remission Unintentional nonadherence: nonadherence to treatment advice due to factors beyond their control Cognitive impairment Physical disability Vision impairment Complex regimens/confusion about regimens Poor understanding of COPD Bryant J, et al. Resp Res. 2013;14:109.

40 Identify and Address Poor Adherence Barriers to Adherence Inadequate education about COPD and therapy 1 Perceived burden of medication regimen 1,2 Device is difficult to use 3 Depressed mood 3 Medication related cost 3 Adverse effects 3 Red Flags for Nonadherence Failure to refill prescriptions Excessive use of rescue medication Frequent exacerbations Rapid decline in FEV 1 1 LaForest L et al. Prim Care Resp J. 2010;19: George J et al. Chest. 2005;128: Restrepo RD et al. Int J COPD. 2008;3:

41 Common Errors in Inhaler Technique, by Inhaler Type Error DPI pmdi BA pmdi pmdi + Spacer Soft Mist Inhaler Failure to remove the mouthpiece cap or device cover X X X X X Incorrect preparation/priming or loading of dose X X X Failure to pierce capsule X Inhaler upside down X X X Breathing out into the device X Firing the device at/after end of inhalation X X Weak or very slow inhalation X X X Open mouth inhalation technique X X Inhaling through the nose X X X X X Stopping inhalation as device is fired X X X X DPI, dry powder inhaler; pmdi, pressurized metered dose inhaler; BA, breath actuated. Newman SP. Eur Respir Rev. 2005;14:

42 Strategies for Improving Adherence to Inhaler Use Delegate education to appropriate staff (eg, PA, NP, or local pharmacist) Match the right device to the patient s unique needs Provide hands on verbal instructions and supplement with written instructions Make sure patient can demonstrate proper technique for each device prescribed before leaving the appointment RE ASSESS THE PATIENT S ABILITY TO USE INHALER(S) AT EVERY FOLLOW UP APPOINTMENT Cate VS. Advance Healthcare Network for NPs and PAs practitioners and physicianassistants.advanceweb.com/features/articles/managing COPD with Inhaler Devices.aspx

43 Exacerbations Acute events characterized by worsening respiratory symptoms that results in a change in therapy 1 Classification 1 Mild: treated with SABDs Moderate: treated with SABDs + antibiotics and/or oral corticosteroids Severe: requires treatment in the emergency room or hospitalization; may be associated with acute respiratory failure Common precipitants 1,2 Respiratory tract infections (viral or bacterial) Pollution Seasonal temperature variations (very cold or very hot, humid temperatures) Risk factors for exacerbations 3 History of prior exacerbations History of wheezing or asthma SABD, short acting bronchodilator. 1 Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/. 2 Hansel NN, et al. COPD. 2016; 13: Hurst JR, et al. N Engl J Med. 2010; 363:

44 Impact of Exacerbations in COPD Patients with Frequent Exacerbations Faster Decline in Lung Function Greater Airway Inflammation Poorer Quality of Life Higher Mortality Adapted from Wedzicha JA, Seemungal TA. Lancet. 2007;370:

45 When Do Exacerbations Require Hospitalization? Severe symptoms, such as sudden worsening of resting dyspnea, high respiratory rate, decreased Sp0 2, change in mental status Acute respiratory failure Onset of new physical findings (e.g., cyanosis, peripheral edema) Failure of response to initial medical management Presence of serious comorbidities (e.g., newly occurring arrhythmia, heart failure) Insufficient support at home Global Initiative for Chronic Obstructive Lung Disease Report. Available at global strategy diagnosis management prevention copd/.

46 Readmission Reduction: Addressing TRANSITIONS OF CARE

47 Conclusions Early, accurate diagnosis of COPD is essential to effective intervention Guidelines are available to inform diagnosis, treatment selection, and monitoring. Bronchodilators, administered using inhalers, are the cornerstone of COPD management Patients require frequent follow up to assess worsening symptoms or decline, adjust treatment as needed, review inhaler practices, and reinforce adherence.

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