chronic obstructive pulmonary disease. what will we cover? diagnosis management of stable copd...
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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 COPDNICE 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 COPDNICE 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 loss Fatigue– Effort intolerance Occupational hazards– Waking at night Chest pain– Ankle swelling Haemoptysis
Use the MRC dyspnoea scale for grading the degree of a patient’s breathlessness
NICE Clinical Guideline 101, June 2010Grade Degree of breathlessness related to activities
1 Not troubled by breathlessness except on strenuous exercise
2 Short of breath when hurrying or walking up a slight hill
3 Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace
4 Stops for breath after walking about 100 metres or after a few minutes on level ground
5 Too breathless to leave the house, or breathless when dressing or undressing
Spirometry in COPDNICE 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 diagnosisNICE 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 asthmaNICE Clinical Guideline 101, June 2010
Feature COPD Asthma
Smoker or ex-smoker Nearly all Possibly
Symptoms under age 35 Rare Often
Chronic productive cough
Common Uncommon
Breathlessness Persistent and progressive
Variable
Night time waking with breathlessness and/or wheeze
Uncommon Common
Significant diurnal or day-to-day variability of symptoms
Uncommon Common
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 featuresNICE 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: 1005-12
Component VariablePoints on the BODE scale
0 1 2 3
BMI BMI (kg/m²) >21 ≤21
Airway Obstruction
FEV1 % predicted
>65 50-64 36-49 ≤35
Dyspnoea MRC scale 1-2 3 4 5
Exercise capacity
Distance (m) walked in 6 min
≥350 250-349 150-249 ≤149
Assessment and classification of airflow obstructionNICE Clinical Guideline 101, June 2010
NICE CG 12 2004
GOLD 2008 NICE CG 101 2010
Post-bronchodilator
FEV1/FVC
FEV1 % predicted Post-bronchodilator
< 0.7 ≥ 80% Stage 1 (mild) Stage 1 (mild)*
<0.7 50-79% Mild Stage 2 (moderate)
Stage 2 (moderate)
<0.7 30-49% Moderate Stage 3 (severe)
Stage 3 (severe)
<0.7 < 30%** Severe Stage 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 careNICE Clinical Guideline 101, June 2010
Mild / moderate / severe(Stages 1 to 3)
Very severe(Stage 4)
Frequency At least annual At least twice per year
Clinical assessment Smoking status and desire to quitAdequacy of symptom controlPresence of complicationsEffects of drug treatmentInhaler techniqueNeed for referral to specialist and therapy servicesNeed for pulmonary rehabilitation
As stages 1 to 3 plus:Presence of cor pulmonaleNeed for long-term oxygen therapy (LTOT)Nutritional statePresence of depressionNeed for social services and occupational therapy input
Measurements to make FEV1 and FVCCalculate BMIMRC dyspnoea scale
As stages 1 to 3 plus SaO2
Referral for specialist adviceNICE 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 managementNICE 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
SummaryDiagnosis
• 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
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– SABA short acting beta2 agonist(s)– LABA long acting beta2 agonist(s)– SAMA short acting muscarinic antagonist(s)– LAMA long acting muscarinic antagonist(s)– ICS Inhaled corticosteroid(s)
Smoking cessationNICE 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 smoked20
Stop smokingNICE Clinical Guideline 101, June 2010
National Knowledge Week for COPD 2008. Available from www.library.nhs.uk
• 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 responseNICE 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 1Breathlessness 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?
Efficacy Safety
No clear evidence for a difference of efficacy
Possible but uncertain CV safety signal with ipratropium
Cost Patient 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 2aMild 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?
Efficacy Safety
No clear evidence of a difference Previous concerns about CV safety of both classes now not thought to be valid
Cost Patient factors
Differences in acquisition costs Different 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 2bSevere to very severe diseaseNICE 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?
Efficacy Safety
Data from INSPIRE. Primary outcome: no significant difference in exacerbations requiring oral corticosteroids or antibiotics or hospitalisationsSecondary 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 alonePossible systemic risks of ICS eg adrenal suppression, BMD, ocular effects etc Give steroid card?Uncertainty regarding worsening of COPD if ICS discontinuedReassurance over tiotropium CV safety
Cost Patient 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 3NICE 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 corticosteroidsNICE 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 theophyllineNICE 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
MucolyticsNICE 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 < 90% for > 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 (FEV1 30-49% predicted)
• Assessment should comprise two arterial blood gas measurements at least 3 weeks apart
• Review annually, including pulse oximetry
Ambulatory and short burst oxygenNICE 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 pulmonaleNICE Clinical Guideline 101, June 2010
• Consider cor pulmonale if patients have:– Peripheral oedema– Raised JVP– Systolic parasternal heave– A loud pulmonary 2nd 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 rehabilitationNICE 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 managementNICE 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 COPDNICE 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 managementNICE 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 exacerbationNICE 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 exacerbationsNICE 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 exacerbationsNICE 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 home Treat in hospitalAble to cope at home Yes No
Breathlessness Mild Severe
General condition Good Poor / deteriorating
Level of activity Good Poor / confined to bed
Cyanosis No Yes
Worsening peripheral oedema No Yes
Level of consciousness Normal Impaired
Already receiving LTOT No Yes
Social circumstances Good Living alone / not coping
Acute confusion No Yes
Rapid rate of onset No Yes
Significant comorbidity No Yes
SaO2 <90% No Yes
Changes on CXR No Yes
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 exacerbationsNICE 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