New Guidelines for COPD They keep changing. . . are you up to speed? by Scott Cerreta, BS, RRT Director of Education www.copdfoundation.org

Conflict of Interest I have no real or perceived conflict of interest that relates to this presentation. Any use of brand names is not in any way meant to be an endorsement of a specific product, but to merely illustrate a point of emphasis.

Objectives Discuss different definitions of COPD Discuss current literature and research that warrants the need to change COPD Guidelines Describe new features of the GOLD Guidelines Describe how these changes will impact diagnosis and treatment recommendations

1. GOLD Definition COPD, a common preventable and treatable disease, is characterized by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. Exacerbations and comorbidities contribute to the overall severity in individual patients.

ATS / ERS Definition Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease state characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.

NHLBI Definition Chronic Obstructive Pulmonary Disease Serious lung disease that over time makes it hard to breathe Emphysema Chronic Bronchitis Blocked (obstructed) airways make it hard to get air in and out So what is COPD? It stands for Chronic Obstructive Pulmonary Disease. COPD is a serious lung disease that progresses slowly and over time, makes it very difficult to breathe. You may also have heard it called by other names. Emphysema and chronic bronchitis are forms of COPD. COPD is a general term that includes a spectrum of diseases. Very often a doctor may say “you have emphysema” when the person has elements of both emphysema and chronic bronchitis. In fact, it is common for people to have elements of both, which is why we prefer the term COPD. In people who have COPD, the airways, or tubes that carry air from the nose and mouth into the lungs, are partially blocked—either because of thickening and mucus, or because the airways are floppy and collapse, or both.

COPD Foundation Definition Chronic Obstructive Pulmonary Disease Serious lung disease that over time makes it hard to breathe Emphysema Chronic Bronchitis Refractory Asthma and Some forms of bronchiectasis Blocked (obstructed) airways make it hard to get air in and out So what is COPD? It stands for Chronic Obstructive Pulmonary Disease. COPD is a serious lung disease that progresses slowly and over time, makes it very difficult to breathe. You may also have heard it called by other names. Emphysema and chronic bronchitis are forms of COPD. COPD is a general term that includes a spectrum of diseases. Very often a doctor may say “you have emphysema” when the person has elements of both emphysema and chronic bronchitis. In fact, it is common for people to have elements of both, which is why we prefer the term COPD. In people who have COPD, the airways, or tubes that carry air from the nose and mouth into the lungs, are partially blocked—either because of thickening and mucus, or because the airways are floppy and collapse, or both.

COPD: Definitions of 21st Century1 Preventable and treatable Airflow limitation that is not fully reversible Progressive disease Abnormal inflammatory response of the lungs Subsets of patients Chronic bronchitis Emphysema Alpha-1 Deficiency Bronchiectasis COPD O2 Dependency OSA, HTN, Others COPD is a general term used to describe a group of patients that suffer from this largely tobacco-causing illness. Three circles represents a more realistic representation of patients suffering from COPD. Many patients have components of both Chronic bronchitis and emphysema as a result of environmental exposures. Patients with asthma and exposure to ETS are more likely to develop symptoms of COPD. COPD is: Read Slide Asthma Box = FEV1/FVC < 70% or < LLN Spirometry is REQUIRED for diagnosis

2. Literature Review COPD Gene Study – Dr. Crapo Why some smokers get COPD & others don’t Using HRCT and identified a large number of people with emphysema despite normal spirometry Spiromics – Dr. Rennard Identifying subsets of people with COPD collection and analysis of phenotypic, biomarker, genetic, genomic, and clinical data from subjects with COPD

Observations from Experts Not all forms of Emphysema or Chronic Bronchitis are COPD. Not all severities of COPD are the same People with same FEV1 have different health status, dyspnea scores, comorbidities, exacerbation history, etc.

Dr. Vesbo, Chair of GOLD states: “Spirometry is essential for the diagnosis of COPD, but it doesn’t fully capture the impact of the disease on individual patients” Example: Some patients with Moderate COPD may have severe breathlessness, while others may have Mild COPD but more prone to acute exacerbations Both groups require more aggressive therapy than past guidelines would recommend

“COPD HETEROGENEITY” Cote & Celli PT # 1 58 y FEV1: 28 % MRC: 2/4 PaO2: 70 mmHg 6MWD: 540 m BMI: 30 PT # 2 62 y FEV1: 33% MRC: 2/4 PaO2: 57 mmHg 6MWD: 400 m BMI: 21 PT # 3 69 y FEV1: 35% MRC: 3/4 PaO2: 66 mmHg 6MWD: 230 m BMI: 34 PT # 4 72 y FEV1: 34% MRC: 4/4 PaO2: 60 mmHg 6MWD: 154 m BMI: 24

GOLD Treatment of COPD FEV1 / FVC < 70% I: Mild II:Moderate FEV1>80% pred II:Moderate FEV1 50-80% pred III: Severe FEV1 30-50% pred IV: Very Severe FEV1 < 30% pred or FEV1 <50% predicted plus respiratory failure Active Reduction of risk factor(s); influenza vaccination Add short-acting bronchodilator when needed Add regular treatment with one or more long-acting bronchodilators: ß2 agonists and anticholinergics Add rehabilitation Add ICS for repeated exacerbations Add LTOT Surgical interventions Recommended Progression of COPD Pharmacotherapy Key Points The chart in this slide summarizes the medications used most often in the treatment of patients with COPD and the stages at which they are most likely to be introduced. As mentioned in the previous slide, therapy should be tailored to match individual patient symptoms. The progression shown here is intended to provide guidance early. Stage I: short-acting inhaled therapy as needed to control dyspnea or coughing spasms is usually sufficient. Stages II-IV: patients whose symptoms are not adequately controlled with as-needed short-acting bronchodilators should receive regular treatment with a long-acting inhaled bronchodilator. Patients with Stages II-IV who are on regular short- or long-acting bronchodilator therapy may also use a short-acting bronchodilator as needed. Some patients may request regular treatment with high-dose nebulized bronchodilators, especially if they have experienced subjective benefit from this treatment during an acute exacerbation. Stages III-IV: regular treatment with inhaled corticosteroids (ICS) is warranted in patients with a postbronchodilator FEV1 <50% predicted and a history of repeated exacerbations (for example, 3 in the last 3 years). This should be added to regular bronchodilator treatment. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease Updated 2003. Available at: www.goldcopd.com/revised.pdf. http://www.goldcopd.org/

3. New Features Added in Dec 2011 GOLD Spirometry Classification Stays NEW is Assessment Model – ABCD mMRC dyspnea scale or COPD Assessment Test (CAT) health status Spirometry classification and Exacerbation History

Assess degree of airflow limitation using spirometry Global Strategy for Diagnosis, Management and Prevention of COPD Assessment of COPD Assess symptoms Assess degree of airflow limitation using spirometry Assess risk of exacerbations Assess comorbidities

(C) (D) (B) (A) Risk Risk Symptoms Global Strategy for Diagnosis, Management and Prevention of COPD Combined Assessment of COPD 4 (C) (D) > 2 3 (Exacerbation history) Risk (GOLD Classification of Airflow Limitation) Risk 2 (A) (B) 1 1 mMRC 0-1 CAT < 10 mMRC > 2 CAT > 10 Symptoms (mMRC or CAT score))

Global Strategy for Diagnosis, Management and Prevention of COPD Assessment of Symptoms COPD Assessment Test (CAT): An 8-item measure of health status impairment in COPD (http://catestonline.org). Breathlessness Measurement using the Modified British Medical Research Council (mMRC) Questionnaire: relates well to other measures of health status and predicts future mortality risk.

Tools: COPD Assessment Test (CAT) Measures health status Based on 8 questions Score from 0 to 5 High scores = symptoms May predict exacerbation May reveal improvement after attending Rehab http://www.catestonline.org/english/index.htm

Global Strategy for Diagnosis, Management and Prevention of COPD Modified MRC (mMRC)Questionnaire

Assess symptoms first (C) (D) (A) (B) If mMRC 0-1 or CAT < 10: Global Strategy for Diagnosis, Management and Prevention of COPD Combined Assessment of COPD Assess symptoms first If mMRC 0-1 or CAT < 10: Less Symptoms (A or C) If mMRC > 2 or CAT > 10: More Symptoms (B or D) (C) (D) (A) (B) mMRC 0-1 CAT < 10 mMRC > 2 CAT > 10 Symptoms (mMRC or CAT score))

In patients with FEV1/FVC < 0.70: Global Strategy for Diagnosis, Management and Prevention of COPD Classification of Severity of Airflow Limitation in COPD* In patients with FEV1/FVC < 0.70: GOLD 1: Mild FEV1 > 80% predicted GOLD 2: Moderate 50% < FEV1 < 80% predicted GOLD 3: Severe 30% < FEV1 < 50% predicted GOLD 4: Very Severe FEV1 < 30% predicted *Based on Post-Bronchodilator FEV1

Global Strategy for Diagnosis, Management and Prevention of COPD Assess Risk of Exacerbations To assess risk of exacerbations use history of exacerbations and spirometry: Two or more exacerbations within the last year or an FEV1 < 50 % of predicted value are indicators of high risk.

Tease Out All Exacerbations Must assess all exacerbations – increase in symptoms that requires change in tx Hospitalizations ER / Urgent Care visits PCP / Pulmonologist visit Ask about infection or use of antibiotics, the most common cause of exacerbation

Assess risk of exacerbations next Global Strategy for Diagnosis, Management and Prevention of COPD Combined Assessment of COPD Assess risk of exacerbations next If GOLD 1 or 2 and only 0 or 1 exacerbations per year: Low Risk (A or B) If GOLD 3 or 4 or two or more exacerbations per year: High Risk (C or D) 4 (C) (D) > 2 3 (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Risk 2 1 (A) (B) 1 mMRC 0-1 CAT < 10 mMRC > 2 CAT > 10 Symptoms (mMRC or CAT score))

Use combined assessment Global Strategy for Diagnosis, Management and Prevention of COPD Combined Assessment of COPD Use combined assessment Patient is now in one of four categories: A: Less symptoms, low risk B: More symptoms, low risk C: Less symptoms, high risk D: More symptoms, high risk > 2 1 (C) (D) (A) (B) mMRC 0-1 CAT < 10 4 3 2 mMRC > 2 CAT > 10 (GOLD Classification of Airflow Limitation) Risk (Exacerbation history) Risk Symptoms (mMRC or CAT score))

Spirometric Classification Exacerbations per year Global Strategy for Diagnosis, Management and Prevention of COPD Combined Assessment of COPD When assessing risk, choose the highest risk according to GOLD grade or exacerbation history Patient Characteristic Spirometric Classification Exacerbations per year mMRC CAT A Low Risk Less Symptoms GOLD 1-2 ≤ 1 0-1 < 10 B More Symptoms > 2 ≥ 10 C High Risk GOLD 3-4 D

Maintenance Care vs. Acute Care Typical hospitalization requires aggressive medication management Goal is to return patient to baseline treatment recommendations Maintenance Therapy requires the least amount of medication to control patient symptoms and health status

*ICS+LABA and *PDE4-inh. or Global Strategy for Diagnosis, Management and Prevention of COPD Manage Stable COPD: Pharmacologic Therapy (Medications in each box are mentioned in alphabetical order, and therefore not necessarily in order of preference.) Patient First choice Second choice Alternative Choices A SAMA prn or SABA prn *LAMA LABA SABA and SAMA Theophylline B *LAMA and LABA SABA and/or SAMA C *ICS + LABA *PDE4-inh. D ICS and *LAMA or *ICS + LABA and *LAMA or *ICS+LABA and *PDE4-inh. or *LAMA and LABA or *LAMA and *PDE4-inh. Carbocysteine

Consequences Of COPD Exacerbations Negative impact on quality of life Impact on symptoms and lung function EXACERBATIONS Accelerated lung function decline Increased economic costs Increased Mortality

Scenario 1 Step 1: assess mMRC or CAT. mMRC=1 Left side, less symptoms Step 2: assess spirometry = FEV1 43% assess exacerbation hx = 2 Upper side, high risk Assessment Score = C

Scenario 1 Old GOLD Recommended Tx New GOLD Recommended Tx FEV1 = 43% Severe Stage 3 Recommended Tx LABA or LAMA or LABA + LAMA ICS New GOLD FEV1 = 43%, Group C Less symp, Hi risk Recommended Tx ICS + LABA or LAMA PDE4 inh.

Scenario 2 Step 1: assess mMRC or CAT. CAT=12 Right side, more symptoms Step 2: assess spirometry = FEV1 81% assess exacerbation hx = 0 Lower side, Low risk Assessment Score = B

Scenario 2 Old GOLD Recommended Tx New GOLD Recommended Tx FEV1 = 81% Mild Stage 1 Recommended Tx SABA prn New GOLD FEV1 = 81%, Group B More symp, Low risk Recommended Tx LAMA or LABA

Scenario 3 Step 1: assess mMRC or CAT. mMRC=4 Right side, more symptoms Step 2: assess spirometry = FEV1 56% assess exacerbation hx = 5 Upper side, High risk Assessment Score = D

Scenario 3 Old GOLD Recommended Tx New GOLD Recommended Tx FEV1 = 56% Moderate Stage 2 Recommended Tx SABA prn LABA or LAMA or LABA + LAMA New GOLD FEV1 = 56%, Group D More symp, Hi risk Recommended Tx ICS + LABA or LAMA PDE4 inh. Add everything else

Global Strategy for Diagnosis, Management and Prevention of COPD, 2011: Summary Prevention of COPD is to a large extent possible and should have high priority Spirometry is required to make the diagnosis of COPD; the presence of a post-bronchodilator FEV1/FVC < 0.70 confirms the presence of persistent airflow limitation and thus of COPD The beneficial effects of pulmonary rehabilitation and physical activity cannot be overstated

“COPD HETEROGENEITY” Cote & Celli PT # 1 58 y FEV1: 28 % MRC: 2/4 PaO2: 70 mmHg 6MWD: 540 m BMI: 30 PT # 2 62 y FEV1: 33% MRC: 2/4 PaO2: 57 mmHg 6MWD: 400 m BMI: 21 PT # 3 69 y FEV1: 35% MRC: 3/4 PaO2: 66 mmHg 6MWD: 230 m BMI: 34 PT # 4 72 y FEV1: 34% MRC: 4/4 PaO2: 60 mmHg 6MWD: 154 m BMI: 24

Global Strategy for Diagnosis, Management and Prevention of COPD Therapeutic Options: Rehabilitation All COPD patients benefit from exercise training programs with improvements in exercise tolerance and symptoms of dyspnea and fatigue. Although an effective pulmonary rehabilitation program is 6 weeks, the longer the program continues, the more effective the results. If exercise training is maintained at home the patient's health status remains above pre- rehabilitation levels.

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Summary Dx of COPD requires Spirometry but definitions vary and change with new evidence Tx of COPD requires new assessment Spirometry, dyspnea score, exacerbation hx and consider comorbidities New ABCD assessment model is more accurate and will improve pt outcomes Learn how you can implement this model into your system to decrease hospitalization rates As you can see, the key to self-managing COPD is more than just taking medicine. It involves a good COPD Action Plan to Optimize Care. Those with Optimal Care will be rewarded with the best quality of Life. In order to know what is recommended for Optimal Care, it starts with learning your FEV1 value and the Stage of COPD that you have. We recommend that patients ask for an annual spirometry test on a good day. And, know your FEV1 ! You will be glad you did. Next slide . . . is Thank You

COPD is: Almost Always Preventable. Almost Always Treatable COPD is: Almost Always Preventable. Almost Always Treatable. Someday Curable. Thank You ! Any Questions?

References

References GOLD Guidelines http://www.goldcopd.org/guidelines-pocket-guide-to-copd-diagnosis.html COPD Gene Study http://www.copdgene.org/ Spiromics http://www.cscc.unc.edu/spir/ COPD Foundation http://www.copdfoundation.org