New Guidelines for COPD They keep changing are

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 1. Discuss different definitions of COPD 2. Discuss current literature and research that warrants the need to change COPD Guidelines 3. Describe new features of the GOLD Guidelines 4. 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

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

COPD: Definitions of 21 st Century 1 Chronic bronchitis Br on • Preventable and treatable • Airflow limitation that is not fully reversible • Progressive disease • Abnormal inflammatory response of the lungs • Subsets of patients ch O 2 Emphysema cy n ie fic ie ct as is COPD -1 A a lph De O cy n de SA , H TN , n pe De O Asthma Box = FEV 1/FVC < 70% or < LLN Spirometry is REQUIRED for diagnosis th er s

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 FEV 1 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 FEV 1: 28 % MRC: 2/4 Pa. O 2: 70 mm. Hg 6 MWD: 540 m BMI: 30 PT # 2 62 y FEV 1: 33% MRC: 2/4 Pa. O 2: 57 mm. Hg 6 MWD: 400 m BMI: 21 PT # 3 69 y FEV 1: 35% MRC: 3/4 Pa. O 2: 66 mm. Hg 6 MWD: 230 m BMI: 34 PT # 4 72 y FEV 1: 34% MRC: 4/4 Pa. O 2: 60 mm. Hg 6 MWD: 154 m BMI: 24

GOLD Treatment of COPD FEV 1 / FVC < 70% I: Mild II: Moderate III: Severe FEV 1>80% pred FEV 1 50 -80% pred FEV 1 30 -50% pred IV: Very Severe FEV 1 < 30% pred or FEV 1 <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: ß 2 agonists and anticholinergics Add rehabilitation Add ICS for repeated exacerbations Add LTOT Surgical interventions http: //www. goldcopd. org/

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

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

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

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 (m. MRC) 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 (m. MRC)Questionnaire

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

Global Strategy for Diagnosis, Management and Prevention of COPD Classification of Severity of Airflow Limitation in COPD* In patients with FEV 1/FVC < 0. 70: GOLD 1: Mild FEV 1 > 80% predicted GOLD 2: Moderate 50% < FEV 1 < 80% predicted GOLD 3: Severe 30% < FEV 1 < 50% predicted GOLD 4: Very Severe FEV 1 < 30% predicted *Based on Post-Bronchodilator FEV 1

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 FEV 1 < 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

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

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

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 m. MRC per year CAT A Low Risk Less Symptoms GOLD 1 -2 ≤ 1 0 -1 < 10 B Low Risk More Symptoms GOLD 1 -2 ≤ 1 >2 ≥ 10 C High Risk Less Symptoms GOLD 3 -4 >2 0 -1 < 10 D High Risk More Symptoms GOLD 3 -4 >2 >2 ≥ 10

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

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 or LABA or SABA and SAMA Theophylline B *LAMA or LABA *LAMA and LABA SABA and/or SAMA Theophylline *LAMA and LABA *PDE 4 -inh. SABA and/or SAMA Theophylline ICS and *LAMA or *ICS + LABA and *LAMA or *ICS+LABA and *PDE 4 -inh. or *LAMA and LABA or *LAMA and *PDE 4 -inh. Carbocysteine SABA and/or SAMA Theophylline C D *ICS + LABA or *LAMA

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 m. MRC or CAT. m. MRC=1 – Left side, less symptoms Step 2: assess spirometry = FEV 1 43% assess exacerbation hx = 2 – Upper side, high risk • Assessment Score = C

Scenario 1 • Old GOLD – FEV 1 = 43% – Severe Stage 3 • Recommended Tx – LABA or LAMA or LABA + LAMA – ICS • New GOLD – FEV 1 = 43%, Group C Less symp, Hi risk • Recommended Tx – ICS + LABA or LAMA – PDE 4 inh.

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

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

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

Scenario 3 • Old GOLD – FEV 1 = 56% – Moderate Stage 2 • Recommended Tx • New GOLD – FEV 1 = 56%, Group D More symp, Hi risk • Recommended Tx – SABA prn – ICS + LABA or LAMA – LABA or LAMA or LABA + LAMA – PDE 4 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 FEV 1/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 FEV 1: 28 % MRC: 2/4 Pa. O 2: 70 mm. Hg 6 MWD: 540 m BMI: 30 PT # 2 62 y FEV 1: 33% MRC: 2/4 Pa. O 2: 57 mm. Hg 6 MWD: 400 m BMI: 21 PT # 3 69 y FEV 1: 35% MRC: 3/4 Pa. O 2: 66 mm. Hg 6 MWD: 230 m BMI: 34 PT # 4 72 y FEV 1: 34% MRC: 4/4 Pa. O 2: 60 mm. Hg 6 MWD: 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 prerehabilitation 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

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

References

References 1. GOLD Guidelines http: //www. goldcopd. org/guidelines-pocket-guide-to-copd-diagnosis. html 2. COPD Gene Study http: //www. copdgene. org/ 3. Spiromics http: //www. cscc. unc. edu/spir/ 4. COPD Foundation http: //www. copdfoundation. org