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COPD Dr D Dimov Definition of COPD Chronic obstructive pulmonary disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually both progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases. Deterioration in Lung Function in Patients with COPD Sutherland E and Cherniack R. N Engl J Med 2004;350:2689-2697 Identify population at risk Identify population at risk Diagnosis Identify population at risk Diagnosis Initial consultation Identify population at risk Diagnosis Initial consultation Clinical review ….. Clinical review Identify population at risk Diagnosis Initial consultation Clinical review ….. Clinical review End of life care Identify population at risk Diagnosis Initial consultation Clinical review ….. Clinical review End of life care Assessment Identify population at risk Diagnosis Initial consultation Clinical review ….. Clinical review End of life care Assessment Education Identify population at risk Diagnosis Initial consultation Clinical review ….. Clinical review End of life care Assessment Education Goals Identify population at risk Diagnosis Initial consultation Clinical review ….. Clinical review End of life care Assessment Education Goals Care plan Identify population at risk Diagnosis Initial consultation Clinical review Assessment Education Smoking Goals Inhalers Care plan Rehabilitation Nebuliser Oxygen ….. Vaccination ….. Clinical review End of life care Identify population at risk Diagnosis Initial consultation Assessment Education Smoking Goals Inhalers Care plan Rehabilitation Clinical review Nebuliser Oxygen ….. Vaccination Assessment Clinical review Goals Care plan End of life care ….. Identify population at risk Diagnosis Initial consultation Assessment Education Smoking Goals Inhalers Care plan Rehabilitation Clinical review Nebuliser Oxygen ….. Exacerbation Vaccination Assessment Clinical review Exacerbation Goals Care plan End of life care ….. Identify population at risk Diagnosis Initial consultation Assessment Education Smoking Goals Inhalers Care plan Rehabilitation Clinical review Nebuliser Self management ….. Home H&H Exacerbation Vaccination Assessment Clinical review Hospital RCU Oxygen Exacerbation Goals Care plan End of life care ….. Diagnose COPD Consider a diagnosis of COPD for people who are: – over 35, and – smokers or ex-smokers, and – have any of these symptoms: - exertional breathlessness - chronic cough - regular sputum production, - frequent winter ‘bronchitis’ - wheeze [2004] Definition of COPD • Airflow obstruction is defined as reduced FEV1/FVC ratio (< 0.7) • It is no longer necessary to have an FEV1 < 80% predicted for definition of airflow obstruction • If FEV1 is ≥ 80% predicted, a diagnosis of COPD should only be made in the presence of respiratory symptoms, for example breathlessness or cough FEV1 = forced expiratory volume in 1 second FVC = forced vital capacity Diagnose COPD – The presence of airflow obstruction should be confirmed by performing post-bronchodilator spirometry [new 2010] – All health professionals involved in the care of people with COPD should have access to spirometry and be competent in the interpretation of the results [2004] • There are multiple interventions with demonstrated or potential high impact on COPD patients. • All high impact interventions are efficient for a selected group of patients with certain severity of disease, impact of disease on patient’s life and phenotype. • Severity of disease, impact of disease on patient’s life and sometimes phenotype change during each individual patient’s lifetime. • How do we make sure that the right interventions are provided for the right patients? • We need to know about: – Severity of disease. – Impact of disease on patient’s life. – Patient’s phenotype. – How the above three change with time? Assess severity of airflow obstruction using reduction in FEV1 NICE clinical guideline 12 (2004) ATS/ERS 2004 GOLD 2008 NICE clinical guideline 101 (2010) Postbronchodilator FEV1/FVC FEV1 % predicted Postbronchodilator Postbronchodilator Postbronchodilator < 0.7 80% Mild Stage 1 (mild) Stage 1 (mild)* < 0.7 50–79% Mild Moderate Stage 2 (moderate) Stage 2 (moderate) < 0.7 30–49% Moderate Severe Stage 3 (severe) Stage 3 (severe) < 0.7 < 30% Severe [new 2010] Very severe Stage 4 (very Stage 4 (very severe)** severe)** * Symptoms should be present to diagnose COPD in people with mild airflow obstruction ** Or FEV1 < 50% with respiratory failure Five-year survival according to the staging of disease severity as defined by the ATS guideline evaluated by the percentage of predicted FEV1. Nishimura K et al. Chest 2002;121:1434-1440 ©2002 by American College of Chest Physicians MRC Dyspnoea Scale Grade 1 Not troubled by breathlessness except on strenuous exercise Grade 2 Short of breath when hurrying or walking up a slight hill Grade 3 Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace Grade 4 Stops for breath after walking about 100m or after a few minutes on level ground Grade 5 Too breathless to leave the house, or breathless when dressing or undressing Fletcher CM et al, BMJ 1959; 2:257-299. Five-year survival according to the level of dyspnea as evaluated by the modified 5-point grading system of Fletcher et al.10. Nishimura K et al. Chest 2002;121:1434-1440 ©2002 by American College of Chest Physicians Oxygen desaturation during the 6MWT measured using a < 90% value as a threshold, and Kaplan-Meier survival curves for all-cause mortality for those patients with FEV1 < 50% of predicted and Pao2 ≥ 60 mm Hg with Spo2 values < 90% or > 90%. Casanova C et al. Chest 2008;134:746-752 ©2008 by American College of Chest Physicians Pulmonary rehabilitation and the BODE index in COPD C. G. Cote1 and B. R. Celli2 Eur Respir J 2005; 26:630-636 Kaplan-Meier survival curves for all patients. Patients participating in pulmonary rehabilitation ( ) manifested a survival advantage compared with patients who declined participation in pulmonary rehabilitation (•). p<0.0001 by log rank. Prognostic influence of BMI. Chailleux E et al. Chest 2003;123:1460-1466 ©2003 by American College of Chest Physicians • The term “cachexia” highlights the preferential loss of muscle over fat, with evidence of increased protein degradation. Friedlander a et al, COPD, 2007, 4:355-384 Body composition and mortality in chronic obstructive pulmonary disease1,2 Annemie MWJ Schols, Roelinka Broekhuizen, Clarie A Weling-Scheepers and Emiel F Wouters American Journal of Clinical Nutrition, Vol. 82, No. 1, 53-59, July 2005 Body-composition categories are linked to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) disease severity stage in a category comparison using the chi-square test. No impairment (n = 232; ); muscle atrophy (n = 40; ); semistarvation (n = 23; ); cachexia (n = 117; ). Cachexia was significantly (P = 0.001) more prevalent in GOLD stage IV (n = 207) than in GOLD stage II (n = 71) or III (n = 134). Body composition and mortality in chronic obstructive pulmonary disease1,2 Annemie MWJ Schols, Roelinka Broekhuizen, Clarie A Weling-Scheepers and Emiel F Wouters American Journal of Clinical Nutrition, Vol. 82, No. 1, 53-59, July 2005 Cox regression plot for survival in different body-composition groups adjusted for age, sex, fat mass index, forced expiratory volume in 1 s, inspiratory vital capacity, arterial oxygen tension, and arterial carbon dioxide tension. Patients with low fat-free mass index [category 1 (cachexia; n = 117), solid black line, and category 3 (muscle atrophy; n = 40), dashed gray line] had a significantly greater risk of mortality than did patients with normal fat-free mass index [category 2 (semistarvation; n = 23), solid gray line, and category 4 (no impairment; n = 232), dashed black line]. Outcomes of patients by exacerbation status and after 2 years of follow-up. Cote C G et al. Chest 2007;131:696-704 ©2007 by American College of Chest Physicians All-cause 14.5-year survival.P. Anthonisen N R et al. Ann Intern Med 2005;142:233-239 ©2005 by American College of Physicians BODE score 0 1 2 3 FEV1 (%) > 65 50-65 35-50 35 or less Distance walked in 6 min (m) >350 250-349 150-250 150 or less MRC dyspnoea 0-1 2 >21 21 or less scale BMI 3 4 Kaplan-Meier Survival Curves for the Four Quartiles of the Body-Mass Index, Degree of Airflow Obstruction and Dyspnea, and Exercise Capacity Index (Panel A) and the Three Stages of Severity of Chronic Obstructive Pulmonary Disease as Defined by the American Thoracic Society (Panel B) Celli B et al. N Engl J Med 2004;350:1005-1012 Celli B et al. N Engl J Med 2004;350:1005-1012 BOD+activity score 0 1 2 3 FEV1 (%) > 65 50-65 35-50 35 or less Number of hours dedicated to cycling or walking per week >4 2-4 1-2 1 or less MRC dyspnoea scale 0-1 2 3 4 BMI >21 21 or less Benzo R et al, ATS 2009, p.A2911 DOSE Index 0 1 2 3 Dyspnea Scale score (MRC) 0-1 2 3 4 Obstruction FEV1 % predicted >50 30-49 <30 Smoking Status Nonsmoker Smoker Exacerbations per year 0-1 2-3 >3 Jones R, Donaldson G, Chavanes N, et al; AJRCCM Vol 180 2009 The DOSE Index Distribution of DOSE Index scores in the Devon validation cohort, presented for various airflow obstruction grades. Solid = severe disease; gray = moderate disease; dashed = mild disease. Jones R C et al, American Journal of Respiratory and Critical Care Medicine Vol 180. pp. 1189-1195, (2009) DOSE Index Correlations 6MWT r = -0.54 p < 0.01 BMI r = -0.30 p < 0.01 BODE r = 0.78 p < 0.01 Jones R, Donaldson G, Chavanes N, et al; AJRCCM Vol 180 2009 Health Care Consumption DOSE ≤ 4 DOSE > 4 p Value Hospital admissions in 12 months 6% 34% < 0.0001 Out-of-hours visits in 12 months (mean) 0.08 0.58 <0.0001 Emergency Department attendances (mean) 0.1 0.44 0.06 Bed days (mean) 0.30 5.4 <0.0001 Jones R, Donaldson G, Chavanes N, et al; AJRCCM Vol 180 2009 ADO Index Points 0 1 2 FEV1 (% predicted 36-64% <35% Dyspnoea 0-1 (MRC scale) 2 3 4 Age 50-59 60-69 70-79 >65% 40-49 3 4 5 80-89 >90 Puhan M, et al; Lancet 2009;374:704-11 ADO Index – Prediction of 3-year mortality 0 1 2 3 A 7.2 % 9.9 % 13.5 18.1 23.9 39.8 38.7 47.2 55.9 64.2 % % % % % % % % 71.8 % B 3.0 % 4.0 % 5.4 % 41.7 % 7.3 % 4 9.8 % 5 6 7 8 9 12.9 16.9 21.8 27.6 34.3 % % % % % 10 A – Patients with longstanding and severe COPD. B – Patients after first hospital admission due to moderate-tosevere COPD. Puhan M, et al; Lancet 2009;374:704-11 Composite Measures of Severity of COPD BODE BOD+activity DOSE ADO Composite Measures of Severity of COPD BODE Age FEV1% MRC BMI Self reported activity Smoking Exacerbations BOD+activity DOSE ADO Composite Measures of Severity of COPD BODE Age FEV1% MRC BMI Self reported activity Smoking Exacerbations BOD+activity DOSE ADO Composite Measures of Severity of COPD BODE Age FEV1% MRC BMI Self reported activity Smoking Exacerbations BOD+activity DOSE ADO Composite Measures of Severity of COPD BODE Age FEV1% MRC BMI Self reported activity Smoking Exacerbations BOD+activity DOSE ADO Psychological Conditions (anxiety, panic disorder and depression) • During the last month have you often been bothered by feeling down, depressed or helpless? • During the last month have you been bothered by having little interest or pleasure in doing things? • Do you feel upset or frightened by your attacks of breathlessness? GPIAG, 2007 Looking at the Patient with COPD Rennard S. N Engl J Med 2004;350:965-966 The classic Venn diagram used to describe the overlapping disease entities included in the definition of COPD and the potential clinical subcategories (American Thoracic Society 1995 Consensus Statement on COPD). Mapel D W Chest 2004;126:150S-158S ©2004 by American College of Chest Physicians Phenotype Observable structural and functional characteristics of an organism determined by its genotype and modulated by its environment: the interactions between ‘‘nature’’ and ‘‘nurture’’ MeiLan K. Han et al, Am J Respir Crit Care Med Vol 182. pp 598–604, 2010 COPD phenotype - clinical and patient-centered perspective Able to classify patients into distinct subgroups that provide prognostic information and allow us to better determine appropriate therapy that alters clinically meaningful outcomes. MeiLan K. Han et al, Am J Respir Crit Care Med Vol 182. pp 598–604, 2010 COPD phenotype - research standpoint Allow the selection of a uniform group of patients and assess the most important outcome measures in that group for therapeutic clinical trials. MeiLan K. Han et al, Am J Respir Crit Care Med Vol 182. pp 598–604, 2010 COPD Phenotype ‘‘a single or combination of disease attributes that describe differences between individuals with COPD as they relate to clinically meaningful outcomes (symptoms, exacerbations, response to therapy, rate of disease progression, or death).’’ MeiLan K. Han et al, Am J Respir Crit Care Med Vol 182. pp 598–604, 2010 Phenotypes of COPD Clinical Physiologic Dyspnoea Frequent exacerbator Low BMI Pulmonary cachexia ICS-responsive Depression & anxiety Non-smokers Airflow limitation BD responsiveness Rapid decliner Airway hyperresponsiveness Hypercapnic Impaired exercise tolerance Hyperinflation COPD Radiologic Emphysema Airways disease Low DLco Pulmonary hypertension The Chronic Care Model of Wagner • Promotion of self management. • Comprehensive system to support clinical management. • Evidence based support for decision making. • Use of clinical guidelines. Wagner EH; Effective Clinical Practice, 1998, 1:2-4. Chronic Disease Management • • • • • • • • Smoking cessation Vaccinations Pharmacological management Exercise and pulmonary rehabilitation Home oxygen therapy Lung volume reduction Treatment of the systemic effects of COPD Palliative and end of life care. Govern Balear Smoking cessation sustained quitters intermittent quitters continuous smokers Anthonisen N, et al. AJRCCM 2002. Smoking Cessation • One year sustained and validated abstinence: – Alone - 3% – Doctor’s advice - 5-7% – Pharmacotherapy and counsellor – 20% Campbell Thorax 2001 All-cause 14.5-year survival.P. Anthonisen N R et al. Ann Intern Med 2005;142:233-239 ©2005 by American College of Physicians UPLIFT Trial Tashkin D et al. N Engl J Med 2008;359:1543-1554 TORCH Trial Calverley et al. NEJM 2007 Breezhaler – single dose dry powder inhaler Onbrez will be delivered in a new, proprietary dry-powder device known as the Breezhaler®. This inhaler has been designed to be robust, compact and straightforward to use by patients. The Breezhaler is a single-dose dry powder inhaler: one capsule must be inserted per inhalation. Onbrez Breezhaler: patient feedback Hear Feel See The Onbrez Breezhaler is designed to help patients know they have taken their medication correctly: Hear: During inhalation, the rotation of the capsule in the Breezhaler causes a whirring sound. Feel: The lactose powder results in a sweet taste in the patient’s mouth during inhalation See: The transparent capsule allows patients to see if any medication remains following inhalation Onbrez Breezhaler – flow rate The low resistance Breezhaler device allows for high airflow rates: the figure below shows that it takes less inspiratory effort for the patient to generate a substantial airflow rate with the Breezhaler than with other widely used Dry Powder Inhalers such as the HandiHaler®, Turbohaler® and Accuhaler® Inspiratory Effort (kPa) Singh et al ATS 2010 Use of inhaled therapies Breathlessness and exercise limitation SABA or SAMA as required* FEV1 ≥ 50% Exacerbations or persistent breathlessness LABA FEV1 < 50% LAMA Discontinue SAMA ________ Offer LAMA in preference to regular SAMA four times a day Persistent exacerbations or breathlessness Offer LABA + ICS in a combination inhaler ________ Consider LABA + LAMA if ICS declined or not tolerated Consider LABA + ICS in a combination inhaler ________ Consider LABA + LAMA if ICS declined or not tolerated LAMA Discontinue SAMA ________ Offer LAMA in preference to regular SAMA four times a day LAMA + LABA + ICS in a combination inhaler * SABAs (as required) may continue at all stages PDE4 Inhibitors - Roflumilast • Patients: – Smoking history of at least 20 pack years. – Age older than 40 years. – Confirmed diagnosis of COPD. – Chronic cough and sputum production. – At least one recorded exacerbation requiring steroids or hospital admission in the previous year. Calverley PMA et al: Lancet 2009;374:685-94 Fabbri LM et al: Lancet 2009;374:695-703 PDE4 Inhibitors - Roflumilast • Outcomes: – Improved lung function and reduced exacerbation rate: • Compared to placebo. • When added to Salmeterol. • When added to Tiotropium Calverley PMA et al: Lancet 2009;374:685-94 Fabbri LM et al: Lancet 2009;374:695-703 PDE4 Inhibitors - Roflumilast • Adverse effects: – Diarrhoea. – Nausea. – Headache. – Weight loss. Calverley PMA et al: Lancet 2009;374:685-94 Fabbri LM et al: Lancet 2009;374:695-703 PDE4 Inhibitors - Roflumilast • Problems: – High level of discontinuation in the first 12 weeks. – Selection of a particular clinical phenotype of COPD patients. – No clear comparison with treatment with inhaled corticosteroids. Calverley PMA et al: Lancet 2009;374:685-94 Fabbri LM et al: Lancet 2009;374:695-703 Other Pharmacological Interventions • • • • • Mucolytics Long term antibiotics Theophylline PDE4 inhibitors – Roflumilast New generation once-daily LABA Indacaterol • Anti TNF antibodies Home Oxygen Therapy • • • • • LTOT. Ambulatory oxygen therapy. Short burst oxygen therapy. Palliative oxygen therapy. Nocturnal oxygen therapy for ChainStokes respiration with central sleep apnoea. • Air travel Govern Balear LTOT MRC. Lancet 1981. NOTT. Ann Intern Med 1980. Over an 18 day period Over a 13 day period Effects of breathing room air and 60% oxygen O’Donnell DE, et al; AJRCCM, 2001 Mar;163(4):892-8. 4 hours plus <90 mins/ day 90min 4hour Borg score for breathlessness before and after exercise in (A) patients breathing oxygen (open symbols) or air (solid symbols) Stevenson, N J, Calverley PMA Thorax 2004;59:668-672 With nose clip With face mask Copyright ©2004 BMJ Publishing Group Ltd. O’Donnell ED et al, Am. J. Respir. Crit. Care Med., Volume 164, Number 5, September 2001, 770-777 NETT trial – high risk subgroup • Patients who should not have LVRS: FEV1<20% and either homogenous emphysema on CT-thorax or carbon monoxide diffuse capacity (uncorrected)<20% – 140 such patients enroled – 70 for LVRS and 70 for medical treatment. – 30 day mortality: medical teratment - 0% LVRS -16% LVRS (all risk factors) - 25% NETT trial – non high risk patients Predominantly upper lobe emphysema Predominantly non-upper lobe emphysema Low exercise capacity RR 0.47 p=0.005 RR 0.81 p=0.49 High exercise capacity RR 0.98 p=0.70 RR 2.06 p=0.02 A, Endobronchial valve (Emphasys, Redwood City, Calif) Yim A. P. C. et al.; J Thorac Cardiovasc Surg 2004;127:1564-1573 Copyright ©2004 The American Association for Thoracic Surgery IBV Catheter Deployment Regular physical activity reduces hospital admission and mortality in Chronic Obstructive Pulmonary Disease: a population based cohort study Garcia-Aymerich J, et al. Thorax 2006 Provide pulmonary rehabilitation Make available to all appropriate people, including those recently hospitalised for an acute exacerbation Tailor multi-component, multidisciplinary interventions to individual patient’s needs [new 2010] Pulmonary rehabilitation An individually tailored multidisciplinary programme of care to optimise patients’ physical and social performance and autonomy Hold at times that suit patients, and in buildings with good access Offer to all patients who consider themselves functionally disabled by COPD Multidisciplinary working – COPD care should be delivered by a multidisciplinary team that includes respiratory nurse specialists – Consider referral to specialist departments (not just respiratory physicians) Specialist department Who might benefit? Physiotherapy People with excessive sputum Dietetic advice People with BMI that is high, low or changing over time Occupational therapy People needing help with daily living activities Social services People disabled by COPD Multidisciplinary palliative care teams People with end-stage COPD (and their families and carers) [2004] Self-management Plan • The main aim of self-management is to prevent exacerbations by life style adaption and to allow patients to acquire the skills to treat their exacerbation at an early stage . Monninkof EM, The Cochrane Library, 2003. Personalised Care Planning • It is widely recognised that personalised care planning underpins excellent management of LTCs. • SHAs have also been asked to ensure that the care plan commitment is included in organisations’ plans for 2010/11 and is cited in the Planning Checklist. DH, LONG TERM CONDITIONS CARE PLANNING COMMITMENT, 04/03/2010 Systemic effects of COPD • Cardiovascular disease • Cachexia • Osteoporosis Managing exacerbations – Minimise impact of exacerbations by: • giving self-management advice on responding promptly to symptoms of exacerbation • starting appropriate treatment with oral steroids and/or antibiotics • use of non-invasive ventilation when indicated • use of hospital-at-home or assisted-discharge schemes – The frequency of exacerbations should be reduced by appropriate use of inhaled corticosteroids and bronchodilators, and vaccinations [2004] Breathlessness “a subjective experience of breathing discomfort” “derives from interactions among multiple physiological, psychological, social, and environmental factors” ATS. Am J Respir Crit Care Med, 1999, 159:321-40. Breathlessness “Patients whose dyspnoea can not be alleviated through further treatment of their COPD have intractable dyspnoea or refractory dyspnoea.” Abernethy AP et al. BMJ, 2003, 327:523-8. Breathlessness – Oxygen Therapy • Palliative oxygen is prescribed when primary goal is relief of breathlessness. • Inconclusive evidence. • Prescribing on case by case basis. • Clear goals of therapy in terms of relief of dyspnoea, improvement in function and improvement in quality of life. • Evaluation of benefit before continuing therapy. Uronis HE et al. International Journal of COPD, 2006:1(3) 289-304 Breathlessness – Pharmacological interventions Opioids • Sustained release morphine preparation – 20 mg od. • Long acting morphine product – 15 mg od increased to 15 mg bd after 5-7 days if the treatment is well tolerated and there is residual breathlessness. • Oxycodone 10 mg od increased to 10 mg bd after 5-7 days in patients not able to take morphine. • Fentanyl transdermal patch is not recommended. • Paients already on morphine – sequential increase of the opioid by 20% of the total daily dose every 3-5 days. Uronis HE et al. International Journal of COPD, 2006:1(3) 289-304 Breathlessness – Pharmacological interventions • Psychotropic drugs. – Benzodiazepines – Diazepam – Anxiolytics – Buspirone – Phenothiazines – Promethazine – SSRIs - Sertraline • Emerging data. – Nebulised furosemide. – Heliox28 Breathlessness – Non-pharmacological interventions • Pulmonary rehabilitation. • Breathing techniques. • “Breathlessness clinics”. – – – – Counseling. Breathing re-training. Relaxation. Coping-adaptation strategies. • Nutrition. • Psychosocial support. Key Priorities of the NICE Clinical Guideline on COPD • • • • Diagnose COPD Stop smoking Promote effective inhaled therapy Provide pulmonary rehabilitation for all who need it • Use non-invasive ventilation • Manage exacerbations • Ensure multidisciplinary working