Chronic Obstructive Pulmonary Disease

What will we cover? Diagnosis Management of stable COPD Management of exacerbations of COPD

What’s new? NICE CG 101 June 2010 (partial update to CG 12)

What does the guidance cover? NICE Clinical Guideline 101, June 2010 Diagnosis – Symptoms – Spirometry – Assessment of severity – Referral for specialist advice Management of stable COPD – Smoking cessation – Inhaled therapy – Oral therapy – Oxygen therapy – Pulmonary hypertension and cor pulmonale – Pulmonary rehabilitation – Vaccination and anti-viral therapy – Lung surgery – Multidisciplinary management – Fitness for general surgery Management of exacerbations – Definition of an exacerbation – Assessment and need for hospital treatment – Investigation of an exacerbation – Hospital-at-home and assisted discharge schemes – Pharmacological management – Non-invasive ventilation – Invasive ventilation – Respiratory physiotherapy – Monitoring recovery – Discharge planning

Diagnosis

Working definition of COPD NICE Clinical Guideline 101, June 2010 COPD is characterised by airflow obstruction that is not fully reversible – Airflow obstruction defined as FEV1/FVC ratio <0.7 – If FEV1 is ≥ 80% predicted, diagnosis requires respiratory symptoms eg breathlessness or cough “There is no single diagnostic test for COPD. Making a diagnosis relies on clinical judgement based on a combination of history, physical examination and confirmation of the presence of airflow obstruction using spirometry” – All health professionals involved in the care of people with COPD should have access to spirometry and be competent in the interpretation of results

Diagnosing COPD NICE Clinical Guideline 101, June 2010 Consider a diagnosis of COPD in patients over the age of 35 who have a risk factor (generally smoking) and who present with one or more of the following symptoms: – Exertional breathlessness – Chronic cough – Regular sputum production – Frequent winter ‘bronchitis’ – Wheeze Also ask about: – Weight lossFatigue – Effort intoleranceOccupational hazards – Waking at nightChest pain – Ankle swellingHaemoptysis

Use the MRC dyspnoea scale for grading the degree of a patient’s breathlessness NICE Clinical Guideline 101, June 2010 GradeDegree of breathlessness related to activities 1Not troubled by breathlessness except on strenuous exercise 2Short of breath when hurrying or walking up a slight hill 3Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace 4Stops for breath after walking about 100 metres or after a few minutes on level ground 5Too breathless to leave the house, or breathless when dressing or undressing

Spirometry in COPD NICE Clinical Guideline 101, June 2010 Spirometry should be performed – At the time of diagnosis – To reconsider the diagnosis, if patients show an exceptionally good response to treatment Measure post-bronchodilator spirometry to confirm diagnosis of COPD Consider alternative diagnoses or investigations in: – Older people without typical symptoms of COPD where the FEV1/FVC ratio is < 0.7 – Younger people with symptoms of COPD where the FEV1/FVC ratio is ≥ 0.7 In most patients routine reversibility testing is not necessary as part of the diagnostic process or to plan initial therapy. It may be unhelpful or misleading

Further investigations at diagnosis NICE Clinical Guideline 101, June 2010 At the time of initial diagnostic evaluation in addition to spirometry all patients should have: – A CXR to exclude other pathologies – A FBC to identify anaemia or polycythaemia – A BMI calculated Additional investigations should be performed to aid management in some circumstances: – PEFR (to exclude asthma if doubt remains) – ECG (to assess cardiac status if features of cor pulmonale)

Clinical features differentiating COPD and asthma NICE Clinical Guideline 101, June 2010 FeatureCOPDAsthma Smoker or ex-smokerNearly allPossibly Symptoms under age 35RareOften Chronic productive cough CommonUncommon BreathlessnessPersistent and progressive Variable Night time waking with breathlessness and/or wheeze UncommonCommon Significant diurnal or day-to-day variability of symptoms UncommonCommon

Diagnosis still in doubt? NICE Clinical Guideline 101, June 2010 Repeated observations of patients over time should be used to help differentiate COPD and asthma The following findings should be used to help identify asthma: – A large (> 400ml) response to bronchodilators – A large (> 400ml) response to 30mg oral prednisolone daily for 2 weeks – Serial peak flow measurements showing 20% or greater diurnal or day- to-day variability Clinically significant COPD is not present if the FEV1 and FEV1/FVC ratio return to normal with drug therapy

Assessment of severity and prognostic features NICE Clinical Guideline 101, June 2010 Disability in COPD can be poorly reflected in the FEV1 Assess severity by the degree of airflow obstruction and disability, the frequency of exacerbations and the following prognostic factors: – FEV1 – Transfer factor for CO (TLCO) – Breathlessness (MRC scale) – Health status – Exercise capacity (eg 6 minute walk test) – BMI – Partial pressure of oxygen in arterial blood (PaO2) – Cor pulmonale Calculate the BODE index to assess prognosis where its component information is currently available

What is BODE? Celli B, et al. NEJM 2004; 350: ComponentVariable Points on the BODE scale 0123 BMIBMI (kg/m²)>21≤21 Airway Obstruction FEV1 % predicted > ≤35 DyspnoeaMRC scale Exercise capacity Distance (m) walked in 6 min ≥ ≤149

Assessment and classification of airflow obstruction NICE Clinical Guideline 101, June 2010 NICE CG GOLD 2008NICE CG Post- bronchodilator FEV1/FVC FEV1 % predictedPost-bronchodilator < 0.7≥ 80%Stage 1 (mild)Stage 1 (mild)* < %MildStage 2 (moderate) < %ModerateStage 3 (severe) Stage 3 (severe) <0.7< 30%**SevereStage 4 (very severe) Stage 4 (very severe) *Symptoms should be present to diagnose COPD in people with mild airflow obstruction **Or FEV1 <50% with respiratory failure

Follow up of patients in primary care NICE Clinical Guideline 101, June 2010 Mild / moderate / severe (Stages 1 to 3) Very severe (Stage 4) FrequencyAt least annualAt least twice per year Clinical assessmentSmoking status and desire to quit Adequacy of symptom control Presence of complications Effects of drug treatment Inhaler technique Need for referral to specialist and therapy services Need for pulmonary rehabilitation As stages 1 to 3 plus: Presence of cor pulmonale Need for long-term oxygen therapy (LTOT) Nutritional state Presence of depression Need for social services and occupational therapy input Measurements to makeFEV1 and FVC Calculate BMI MRC dyspnoea scale As stages 1 to 3 plus SaO2

Referral for specialist advice NICE Clinical Guideline 101, June 2010 Reasons for referral include: Diagnostic uncertainty Suspected severe COPD Patient requests a second opinion Onset of cor pulmonale Assessment for oxygen therapy Assessment for long-term nebuliser therapy Assessment for oral corticosteroid therapy Bullous lung disease Rapid decline in FEV1 Assessment for pulmonary rehabilitation Assessment for lung volume reduction surgery Assessment for lung transplantation Dysfunctional breathing Onset of symptoms <40 years or a family history of alpha-1 antitrypsin deficiency Uncertain diagnosis Symptoms disproportionate to lung function deficit Frequent infections haemoptysis

Multidisciplinary management NICE Clinical Guideline 101, June 2010 “...breaking down historic demarcation of roles...Competencies are more important than professional boundaries” Guidance on activity of MDT and specifically: – Respiratory nurse specialists – Physiotherapy – Identifying and managing anxiety and depression – Nutritional factors – Palliative care – Assessment for occupational therapy – Social services – Advice on travel – Education – self-management

Summary Diagnosis New NICE guidance June 2010 Key priorities in diagnosing COPD: – Consider in people >35 years who have a risk factor (generally smoking) with symptoms – Post-bronchodilator spirometry to confirm diagnosis; reversibility testing usually not necessary New NICE classification of severity of airflow obstruction New recommendations on assessment of severity

Management of stable COPD

Smoking cessation Inhaled therapy Oral therapy Oxygen therapy Pulmonary hypertension and cor pulmonale Pulmonary rehabilitation Vaccination and anti-viral therapy Lung surgery Multidisciplinary management Fitness for general surgery

What’s new? NICE Clinical Guideline 101, June 2010 Previous NICE guidance had separate recommendations on bronchidilators and inhaled corticosteroids for: – Symptom control – Reduction in risk of exacerbations The current guidance combines and revises these recommendation for – SABAshort acting beta2 agonist(s) – LABAlong acting beta2 agonist(s) – SAMA short acting muscarinic antagonist(s) – LAMA long acting muscarinic antagonist(s) – ICSInhaled corticosteroid(s)

Smoking cessation NICE Clinical Guideline 101, June 2010 Document an up to date smoking history, including pack years smoked, for everyone with COPD Encourage all COPD patients still smoking to stop, and offer help to do so, at every opportunity Unless contraindicated, offer NRT, varenicline or bupropion as appropriate, combined with an appropriate support programme Pack years = no cigarettes smoked per day x no years smoked 20

Stop smoking NICE Clinical Guideline 101, June 2010 National Knowledge Week for COPD Available from Approximately 80% of COPD is caused by smoking Getting patients with COPD to stop smoking is one of the single most important interventions Stopping smoking slows the rate of decline in FEV1 with consequent benefits in terms of progression of symptoms and survival Campaigns aimed at smokers need to emphasise link between smoking and COPD

Inhaled therapy – assessing response NICE Clinical Guideline 101, June 2010 The effectiveness of bronchodilator therapy should not be assessed by lung function alone but should include a variety of other measures such as improvement in: – Symptoms – Activities of daily living – Exercise capacity – Rapidity of symptoms relief The choice of drug should take into account: – Person’s symptomatic response and preference – Drug’s potential to reduce exacerbations – Side-effects – Costs

Inhaled therapy – what device? NICE Clinical Guideline 101, June 2010 In most, bronchodilators are best administered using a hand-held inhaler (with spacer is appropriate) Prescribe inhalers only after patients have been trained in their use and demonstrated satisfactory technique – Assess ability regularly and re-teach if necessary Consider patients for nebulisers if they are on maximal inhaler therapy but still have distressing or disabling breathlessness Continue with nebulisers if there is one or more of: – Reduction in symptoms – Increased ability to undertake activities of daily living – Increased exercise capacity – Improvement in lung function

Inhaled therapy – level 1 Breathlessness and exercise limitation NICE Clinical Guideline 101, June 2010 SABA (salbutamol) or SAMA (ipratropium) as required Short-acting bronchodilators, as necessary, should be the empirical treatment for the relief of breathlessness and exercise limitation Should we offer a SABA or SAMA first? Is it worth swapping if the first one doesn’t work?

Should I offer a SABA or a SAMA first? EfficacySafety No clear evidence for a difference of efficacy Possible but uncertain CV safety signal with ipratropium CostPatient factors Differentials depend on dose and device used Particular inhaler devices may be more or less suitable for individuals

Is it worth swapping if the first option chosen doesn’t work? NICE doesn’t address this Seems a reasonable approach Choice for individuals probably depends most on: – Which device they can use – Which drug they tolerate best – How effective it is for their symptoms

Inhaled therapy – level 2a Mild to moderate disease NICE Clinical Guideline 101, June 2010 Offer a LABA (salmeterol) or LAMA (tiotropium) to people who: – Remain breathless or have exacerbations despite SABA or SAMA as required and – Have FEV1 ≥ 50% predicted Use a LAMA in preference to regular 4x daily SAMA if regular therapy with an antimuscarinic is chosen Those started on a LABA can continue with their SABA or SAMA Those started on a LAMA should stop their SAMA (if they were using one) Should we use a LABA or LAMA? Is it worth swapping between LABA and LAMA is the first one tried doesn’t work?

Should we offer a LABA or LAMA first? EfficacySafety No clear evidence of a differencePrevious concerns about CV safety of both classes now not thought to be valid CostPatient factors Differences in acquisition costsDifferent inhaler devices may be more or less suitable for individuals

Is it worth swapping if the first option chosen doesn’t work? NICE does not address this Seems a reasonable approach

Inhaled therapy – level 2b Severe to very severe disease NICE Clinical Guideline 101, June 2010 Offer a LABA + ICS combination inhaler (symbicort), or LAMA to people with stable COPD who: – Remain breathless or have exacerbations despite SABA or SAMA as required and – Have FEV1 <50% predicted Use a LAMA in preference to regular 4x daily SAMA if regular therapy with an antimuscarinic is chosen Those started on a LABA + ICS can continue with their SABA or SAMA Those started on a LAMA should stop their SAMA (if they were using one) Should we offer a LABA + ICS or a LAMA? Is it worth swapping if the first option chosen does not work? What are the risks of ICS? What about LABA + LAMA

Inhaled corticosteroids – what does NICE say? NICE Clinical Guideline 101, June 2010 Oral corticosteroid reversibility tests do not predict response to ICS – Do not use them to identify which patients should be prescribed ICS Be aware of the potential risk of developing side effects (including non- fatal pneumonia) in people with COPD treated with ICS and be prepared to discuss with patients

Should we offer a LABA + ICS or a LAMA first? EfficacySafety Data from INSPIRE. Primary outcome: no significant difference in exacerbations requiring oral corticosteroids or antibiotics or hospitalisations Secondary outcomes include reduction in all-cause mortality and 2 point benefit in SGRQ from LABA + ICS vs LAMA ICS increase risk of pneumonia compared with LABA alone Possible systemic risks of ICS eg adrenal suppression, BMD, ocular effects etc Give steroid card? Uncertainty regarding worsening of COPD if ICS discontinued Reassurance over tiotropium CV safety CostPatient factors Comparative cost-effectiveness uncertain. LABA + ICS has higher acquisition costs Different inhaler devices may be more or less suitable for individuals

Inhaled therapy – level 3 NICE Clinical Guideline 101, June 2010 For people with stable COPD and FEV1 ≥ 50% predicted who are using a LABA and who remain breathless or have exacerbations – Consider a LABA + ICS combination inhaler (less strong evidence) – Consider LAMA + LABA if ICS declined or not tolerated (less strong evidence) Irrespective of FEV1 if person is breathless or has exacerbations – Offer LAMA + LABA + ICS for those on LABA + ICS (strong evidence) – Consider LAMA + LABA + ICS for those on LAMA (less strong evidence

Other therapies and interventions

Oral corticosteroids NICE Clinical Guideline 101, June 2010 Maintenance use of oral corticosteroid therapy in COPD is not normally recommended If oral steroids cannot be withdrawn following an exacerbation in patients with advanced COPD, keep the maintenance dose as low as possible Monitor patients with long-term oral corticosteroid therapy for the development of osteoporosis and give appropriate prophylaxis Start patients over the age of 65 on prophylactic treatment without monitoring

Oral theophylline NICE Clinical Guideline 101, June 2010 Use theophylline only after a trial of short-acting and long acting bronchodilators, or in patients who are unable to use inhaled therapy – Use a slow-release formulation Use with caution in the elderly Assess effectiveness of the treatment by improvements in: – Symptoms – Activities of daily living – Exercise capacity – Lung function Reduce the dose if interacting drugs are prescribed – Examples antibiotics used to treat exacerbations

Mucolytics NICE Clinical Guideline 101, June 2010 Consider in patients with a chronic cough productive of sputum Continue if there is symptomatic improvement (eg reduction in cough frequency and sputum production) Do not routinely use to prevent exacerbations in people with stable COPD

What about beta-blockers? BNF 60 Sept 2010 – “When there is no suitable alternative, it may be necessary for a patient with well controlled asthma, or COPD (without significant reversible airways obstruction) to receive treatment with a beta- blocker for a co-existing condition (eg heart failure, post-MI)”...a cardioselective beta-blocker should be initiated at a low dose by a specialist, and the patient monitored for adverse effects DTB 2011, 49(1): 2-5 – “Observational studies indicate that cardioselective beta-blockers can be used in patients with COPD with mild to moderate airflow obstruction without impairing lung function or response to beta- agonists, and such use may reduce hospitalisation and mortality”

Long term oxygen therapy (LTOT) NICE Clinical Guideline 101, June 2010 Inappropriate O2 therapy in people with COPD may cause respiratory depression Pulse oximetry should be available in all healthcare settings Indicated if PaO2 < 7.3kPa when stable or < 8kPa when stable and one of: – Secondary polycythaemia – Nocturnal hypoxaemia (SaO2 30% of the time) – Peripheral oedema – Pulmonary hypertension Patients should breaths supplemental O2 at least 15 hours per day, preferably 20 hours per day

Assess need for O2 therapy in people with: – Very severe COPD (FEV1 < 30% predicted) – Cyanosis – Polycythaemia – Peripheral oedema – Raised JVP – O2 saturations ≤ 92% when breathing air Consider assessment in those with severe COPD (FEV % predicted) Assessment should comprise two arterial blood gas measurements at least 3 weeks apart Review annually, including pulse oximetry

Ambulatory and short burst oxygen NICE Clinical Guideline 101, June 2010 Ambulatory oxygen therapy: – People on LTOT who wish to continue O2 away from home – People with exercise desaturation whose exercise capacity and/or dyspnoea improve with O2 – Only after specialist assessment Short-burst oxygen therapy: – Only for severe breathlessness not relieved by other treatments – Only if improvement documented

Pulmonary hypertension and cor pulmonale NICE Clinical Guideline 101, June 2010 Consider cor pulmonale if patients have: – Peripheral oedema – Raised JVP – Systolic parasternal heave – A loud pulmonary 2 nd heart sound Assess patients with cor pulmonale for LTOT Oedema associated with cor pulmonale can usually be controlled symptomatically with diuretic therapy The following are not recommended for the treatment of cor pulmonale: – ACE inhibitors – Calcium channel blockers – Alpha-blockers – Digoxin (unless there is AF)

Pulmonary rehabilitation NICE Clinical Guideline 101, June 2010 Includes multicomponent, multidisciplinary interventions, which are tailored to the individual patient’s needs including: – Physical training – Disease education – Nutritional, psychological and behavioural intervention Should be made available to all appropriate people with COPD including those who have had a recent hospitalisation for an acute exacerbation Should be offered to all patients who consider themselves functionally disabled by COPD (usually MRC grade ≥ 3) Is not suitable who: – Are unable to walk – Have unstable angina – Have had a recent MI

Other issues in management NICE Clinical Guideline 101, June 2010 Offer pneumococcal and annual influenza immunisation Consider bullectomy, lung volume reduction surgery or lung transplantation in selected patients Do not use alpha-1 antitrypsin replacement therapy in patients with deficiency Review patients with COPD at least annually and twice yearly in those with very severe COPD

Palliative care in end-stage COPD NICE Clinical Guideline 101, June 2010 Use opiates appropriately for the palliation of breathlessness in end-stage COPD Use benzodiazepines, tricyclics, major tranquillisers and O2 where appropriate Involve multidisciplinary palliative care teams

Multidisciplinary management NICE Clinical Guideline 101, June 2010 “...breaking down historic demarcation of roles...competencies are more important than professional boundaries” Guidance on activity of multidisciplinary team and specifically: – Respiratory nurse specialists – Physiotherapy – Identifying and managing anxiety and depression – Nutritional factors – Palliative care – Assessment for occupational therapy – Social services – Advice on travel – Education – Self-management

Managing exacerbations of COPD

Management of exacerbations Definition of an exacerbation Assessment and need for hospital treatment Investigation of an exacerbation Hospital-at-home and assisted discharge schemes Pharmacological management Non-invasive ventilation Invasive ventilation Respiratory physiotherapy Monitoring recovery Discharge planning

Definition of an exacerbation NICE Clinical Guideline 101, June 2010 A sustained worsening of the patient’s symptoms from his or her usual stable state that is beyond normal day-to-day variations, and is acute in onset Commonly reported symptoms are: – Worsening breathlessness – Cough – Increased sputum production – Change in sputum colour

Self-management of exacerbations NICE Clinical Guideline 101, June 2010 Give self-management advice to respond promptly to the symptoms of an exacerbation by: – Start oral corticosteroids if increased breathlessness interferes with activities of daily living – Start antibiotics if sputum is purulent – Adjust bronchodilator therapy to control symptoms – Contact a healthcare professional if they do not improve Give patients a course of antibiotics and corticosteroids to keep at home for use as part of a self-management plan – Monitor appropriate use

Investigation and management of exacerbations NICE Clinical Guideline 101, June 2010 Diagnosis is made clinically and does not depend on the results of invesigations In primary care – Routine sputum culture is not recommended – Pulse oximetry valuable if clinical features of severe exacerbation More extensive investigations in patients managed in hospital Use hospital-at-home and assisted-discharge schemes as an alternative for patients who would otherwise need to be admitted or stay in hospital

Treat in hospital or at home? NICE Clinical Guideline 101, June 2010 Treat at homeTreat in hospital Able to cope at homeYesNo BreathlessnessMildSevere General conditionGoodPoor / deteriorating Level of activityGoodPoor / confined to bed CyanosisNoYes Worsening peripheral oedemaNoYes Level of consciousnessNormalImpaired Already receiving LTOTNoYes Social circumstancesGoodLiving alone / not coping Acute confusionNoYes Rapid rate of onsetNoYes Significant comorbidityNoYes SaO2 <90%NoYes Changes on CXRNoYes Arterial pH≥ 7.35< 7.35 Arterial PaO2≥ 7kPa< 7kPa

Drug management of exacerbations NICE Clinical Guideline 101, June 2010 Use nebuliser or hand-held inhalers for inhaled therapy – Change to hand-held inhalers as soon as condition stablises – Always state driving gas for nebulised therapy Oral corticosteroids – Use in all admitted to hospital – Consider in community if significant increase in breathlessness – Prednisolone 30mg daily for 7-14 days

Drug management of exacerbations NICE Clinical Guideline 101, June 2010 Antibiotics – More purulent sputum – Consolidation on CXR – Clinical signs or pneumonia IV theophylline only if inadequate response to nebulised bronchodilators Doxapram only if non-invasive ventilation (NIV) unavailable or inappropriate

Other aspects of management of exacerbations NICE Clinical Guideline 101, June 2010 Oxygen therapy – Monitor saturation if can’t do blood gases – Give oxygen if necessary – All healthcare professionals involved in care should have access to pulse oximeters Non-invasive ventilation (NIV) Invasive ventilation and intensive care – Treatment of choice for persistent hypercapnic ventilatory failure during exacerbations Respiratory physiotherapy Monitoring recovery Discharge planning

Summary - managing exacerbations Frequency of exacerbations should be reduced by: – Effective inhaled therapy – Vaccinations Impact of exacerbations should be minimised by: – Giving self-management advice on responding promptly to the symptoms of an 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