summarising clinical guidelines for primary care Chronic obstructive pulmonary disease in over 16s: diagnosis and management

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1 summarising clinical guidelines for primary care Chronic obstructive pulmonary disease in over 16s: diagnosis and management National Institute for Health and Care Excellence PREPRINT cpd credits The production and printing of this Guidelines preprint has been funded by GSK UK. See inside front cover for full disclaimer. Prescribing information can be found on the outside back cover. Date of preparation: December 2018

2 When a clinical guideline describes a drug therapy, readers should refer to the full summary of product characteristics to confirm licensed indications and the clinical significance of a product s contraindications, special precautions, drug interactions, adverse reactions, or overdose. While every care has been taken to ensure the accuracy of this Guidelines summary, this does not diminish the requirement to exercise clinical judgement and the publisher cannot accept liability for any errors and omissions. The production and printing of this Guidelines preprint has been funded by GSK UK. While this preprint has been reviewed for factual accuracy, GSK UK has had no editorial input into the content. NICE (2018) Chronic obstructive pulmonary disease in over 16s: diagnosis and management. Available from All rights reserved. Subject to Notice of rights (see NICE guidance is prepared for the National Health Service in England. All guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this publication. There has been no contact between the sponsors and NICE in the development of this Guidelines preprint. The views and opinions in this preprint are not necessarily those of GSK UK, or of Guidelines, its publisher, advisers, or advertisers. MGP Ltd owns copyright of the Guidelines brand, logo, and the design and format of this Guidelines summary preprint. MGP Ltd 2018 Date of preparation: December 2018

3 Chronic obstructive pulmonary disease in over 16s: diagnosis and management National Institute for Health and Care Excellence This Guidelines summary covers the following topics: prognosis further investigations incidental findings on chest X ray or CT scans inhaled therapy oral therapy oxygen therapy education and self-management pulmonary hypertension and cor pulmonale pharmacological management of COPD Recommendations that are new to the 2018 updated guideline are marked with (2018), amended recommendations for the 2018 updated guideline are marked with (amended 2018) Diagnosing COPD The diagnosis of chronic obstructive pulmonary disease (COPD) depends on thinking of it as a cause of breathlessness or cough. The diagnosis is suspected on the basis of symptoms and signs, and is supported by spirometry Symptoms Suspect a diagnosis of COPD in people over 35 who have a risk factor (generally smoking or a history of smoking) and who present with one or more of the following symptoms: exertional breathlessness chronic cough regular sputum production frequent winter bronchitis wheeze When thinking about a diagnosis of COPD, ask the person if they have: weight loss reduced exercise tolerance waking at night with breathlessness ankle swelling fatigue occupational hazards chest pain haemoptysis (coughing up blood) these last two symptoms are uncommon in COPD and raise the possibility of alternative diagnoses One of the primary symptoms of COPD is breathlessness. The Medical Research Council (MRC) dyspnoea scale (see table 1) should be used to grade the breathlessness according to the level of exertion required to elicit it Table 1: MRC dyspnoea scale GRADE 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 Adapted from Fletcher CM, Elmes PC, Fairbairn MB et al. (1959) The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. British Medical Journal 2: Spirometry Perform spirometry: at diagnosis to reconsider the diagnosis, for people who show an exceptionally good response to treatment to monitor disease progression (amended 2018) 3

4 Measure post-bronchodilator spirometry to confirm the diagnosis of COPD Think about alternative diagnoses or investigations for older people who have an FEV 1 /FVC ratio below 0.7 but do not have typical symptoms of COPD Think about a diagnosis of COPD in younger people who have symptoms of COPD, even when their FEV 1 /FVC ratio is above 0.7 All healthcare professionals who care for people with COPD should have access to spirometry and be competent in interpreting the results Spirometry can be performed by any healthcare worker who has had appropriate training and has up-to-date skills Spirometry services should be supported by quality-control processes It is recommended that Global Lung Function Initiative GLI 2012 reference values are used, but it is recognised that these values are not applicable for all ethnic groups (amended 2018) Incidental findings on chest X-rays or CT scans (2018) Consider primary care respiratory review and spirometry (see Spirometry, page 3) for people with emphysema or signs of chronic airways disease on a chest X-ray or CT scan If the person is a current smoker, their spirometry results are normal and they have no symptoms or signs of respiratory disease: offer smoking cessation advice and treatment, and referral to specialist stop smoking services (see the NICE guideline on stop smoking interventions and services) warn them that they are at higher risk of lung disease advise them to return if they develop respiratory symptoms be aware that the presence of emphysema on a CT scan is an independent risk factor for lung cancer If the person is not a current smoker, their spirometry is normal and they have no symptoms or signs of respiratory disease: ask them if they have a personal or family history of lung or liver disease and consider alternative diagnoses, such as alpha-1 antitrypsin deficiency reassure them that their emphysema or chronic airways disease is unlikely to get worse advise them to return if they develop respiratory symptoms be aware that the presence of emphysema on a CT scan is an independent risk factor for lung cancer Further investigations In addition to spirometry all patients should have: a chest radiograph to exclude other pathologies a full blood count to identify anaemia or polycythaemia body mass index (BMI) calculated For further information on additional investigations, please refer to our Guidelines summary online at: guidelines.co.uk/nice/ copd Reversibility testing For most people, routine spirometric reversibility testing is not necessary as part of the diagnostic process or to plan initial therapy with bronchodilators or corticosteroids Untreated COPD and asthma are frequently distinguishable on the basis of history (and examination) in people presenting for the first time. Whenever possible, use features from the history and examination (such as those listed in table 2, page 5) to differentiate COPD from asthma. For more information on diagnosing asthma, see the NICE guideline on asthma (amended 2018) 4

5 Table 2: Clinical features differentiating COPD and asthma 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 In addition to the features in table 2, use longitudinal observation of people (with spirometry, peak flow or symptoms) to help differentiate COPD from asthma When diagnostic uncertainty remains, or both COPD and asthma are present, use the following findings to help identify asthma: a large (over 400 ml) response to bronchodilators a large (over 400 ml) response to 30 mg 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 FEV 1 and FEV 1 /FVC ratio return to normal with drug therapy If diagnostic uncertainty remains, think about referral for more detailed investigations, including imaging and measurement of transfer factor for carbon monoxide (TLCO) Reconsider the diagnosis of COPD for people who report a marked improvement in symptoms in response to inhaled therapy Assessing severity and using prognostic factors COPD is heterogeneous, so no single measure can adequately assess disease severity in an individual. Severity assessment is, nevertheless, important because it has implications for therapy and relates to prognosis Do not use a multidimensional index (such as BODE) to assess prognosis in people with stable COPD (2018) From diagnosis onwards, when discussing prognosis and treatment decisions with people with stable COPD, think about the following factors that are individually associated with prognosis: FEV 1 smoking status breathlessness (MRC scale) chronic hypoxia and/or cor pulmonale low BMI severity and frequency of exacerbations hospital admissions symptom burden (for example, COPD Assessment Test [CAT] score) exercise capacity (for example, 6-minute walk test) TLCO whether the person meets the criteria for long-term oxygen therapy and/or home non-invasive ventilation multimorbidity (see the NICE guideline on multimorbidity) frailty (amended 2018) Assessing and classifying the severity of airflow obstruction Assess the severity of airflow obstruction according to the reduction in FEV 1 as shown on table 3, page 6 For people with mild airflow obstruction, only diagnose COPD if they have one or more of the symptoms (described in Symptoms, page 3) 5

6 Table 3: Gradation of severity of airflow obstruction Postbronchodilator FEV 1 /FVC FEV 1 % predicted NICE GUIDELINE CG12 (2004) ATS/ERS Severity of airflow obstruction GOLD NICE GUIDELINE CG101 (2010) Postbronchodilator Postbronchodilator Postbronchodilator <0.7 80% Mild Stage 1 Mild Stage 1 Mild < % Mild Moderate Stage 2 Moderate Stage 2 Moderate < % Moderate Severe Stage 3 Severe Stage 3 Severe <0.7 <30% Severe Very severe Stage 4 Very severe* Stage 4 Very severe* * Or FEV 1 below 50% with respiratory failure. 1 Celli BR, MacNee W, Agusti A et al. (2004) Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. European Respiratory Journal 23 (6): Global Initiative for Chronic Obstructive Lung Disease (GOLD; 2008) Global strategy for the diagnosis, management and prevention of COPD. Table 4: Reasons for referral include REASON There is diagnostic uncertainty Suspected severe COPD The person with COPD 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 A rapid decline in FEV 1 Assessment for pulmonary rehabilitation Assessment for a lung volume reduction procedure Assessment for lung transplantation Dysfunctional breathing Onset of symptoms under 40 years or a family history of alpha-1 antitrypsin deficiency Symptoms disproportionate to lung function deficit Frequent infections Haemoptysis PURPOSE Confirm diagnosis and optimise therapy Confirm diagnosis and optimise therapy Confirm diagnosis and optimise therapy Confirm diagnosis and optimise therapy Optimise therapy and measure blood gases Optimise therapy and exclude inappropriate prescriptions Justify need for continued treatment or supervise withdrawal Identify candidates for lung volume reduction procedures Encourage early intervention Identify candidates for pulmonary rehabilitation Identify candidates for surgical or bronchoscopic lung volume reduction Identify candidates for surgery Confirm diagnosis, optimise pharmacotherapy and access other therapists Identify alpha-1 antitrypsin deficiency, consider therapy and screen family Look for other explanations including cardiac impairment, pulmonary hypertension, depression and hyperventilation Exclude bronchiectasis Exclude carcinoma of the bronchus 6

7 Figure 1: Non-pharmacological management and use of inhaled therapies This is a summary of the recommendations on non-pharmacological management of chronic obstructive pulmonary disease and use of inhaled therapies in people over 16. The guideline also covers diagnosis and other areas of management (see Confirmed diagnosis of COPD Fundamentals of COPD care Offer treatment and support to stop smoking Offer pneumococcal and infl uenza vaccinations Offer pulmonary rehabilitation if indicated Co-develop a personalised self-management plan Optimise treatment for comorbidities These treatments and plans should be revisited at every review Start inhaled therapies only if: all the above interventions have been offered (if appropriate), and inhaled therapies are needed to relieve breathlessness or exercise limitation Inhaled therapies Offer SABA or SAMA to use if needed Person still breathless or has exacerbations despite treatment? No asthmatic features/features suggesting steroid responsiveness* Asthmatic features/features suggesting steroid responsiveness* Offer LABA + LAMA Consider LABA + ICS For ALL inhaled therapies: Train people in correct inhaler technique, and review medication and assess inhaler technique and adherence regularly Person still breathless or has exacerbations despite further treatment? Offer LAMA + LABA + ICS Explore further treatment options if needed (see full guideline at: COPD=chronic obstructive pulmonary disease; SABA=short-acting beta 2 agonists; SAMA=short-acting muscarinic antagonists, LABA=long-acting beta 2 agonists, LAMA=long-acting muscarinic antagonists, ICS=inhaled corticosteroids; FEV 1 =forced expiratory volume in the fi rst second. *Asthmatic features/features suggesting steroid responsiveness in this context include any previous secure diagnosis of asthma or atopy, a higher blood eosinophil count, substantial variation in FEV 1 over time (at least 400 ml) or substantial diurnal variation in peak expiratory fl ow (at least 20%). 7

8 Referral for specialist advice When clinically indicated, refer people for specialist advice. Referral may be appropriate at all stages of the disease and not solely in the most severely disabled people (see table 4, page 6) Managing stable COPD See Figure 1, page 7 for a visual summary covering non-pharmacological management and use of inhaled therapies (2018) For guidance on the management of multimorbidity, see the NICE guideline on multimorbidity (2018) Inhaled therapy Short-acting beta 2 agonists (SABA) and short-acting muscarinic antagonists (SAMA) Use short-acting bronchodilators, as necessary, as the initial empirical treatment to relieve breathlessness and exercise limitation Inhaled corticosteroids (ICS) Do not use oral corticosteroid reversibility tests to identify which people should be prescribed inhaled corticosteroids, because they do not predict response to inhaled corticosteroid therapy Be aware of, and be prepared to discuss with the person, the risk of side-effects (including pneumonia) in people who take inhaled corticosteroids for COPD* (amended 2018) Inhaled combination therapy Inhaled combination therapy refers to combinations of long-acting muscarinic antagonists (LAMA), long-acting beta 2 agonists (LABA) and inhaled corticosteroids (ICS) Do not assess the effectiveness of bronchodilator therapy using lung function alone. Include a variety of other measures such as improvement in symptoms, activities of daily living, exercise capacity, and rapidity of symptom relief Offer LAMA+LABA to people who: have spirometrically confirmed COPD and do not have asthmatic features/features suggesting steroid responsiveness and remain breathless or have exacerbations despite: having used or been offered treatment for tobacco dependence if they smoke and optimised non-pharmacological management and relevant vaccinations and using a short-acting bronchodilator (2018) Consider LABA+ICS for people who: have spirometrically confirmed COPD and have asthmatic features/features suggesting steroid responsiveness and remain breathless or have exacerbations despite: having used or been offered treatment for tobacco dependence if they smoke and optimised non-pharmacological management and relevant vaccinations and using a short-acting bronchodilator (2018) For people using long-acting bronchodilators outside of the recommendations above, and before this guideline was published (December 2018), explain to them that they can continue with their current treatment until both they and their NHS healthcare professional agree it is appropriate to change (2018) Offer LAMA+LABA+ICS to people with COPD with asthmatic features/features suggesting steroid responsiveness who remain breathless or have exacerbations despite taking LABA+ICS (amended 2018) 8

9 Base the choice of drugs and inhalers on: how much they improve symptoms the person s preferences and ability to use the inhalers the drugs potential to reduce exacerbations their side-effects their cost Minimise the number of inhalers and the number of different types of inhaler used by each person as far as possible (2018) When prescribing long-acting drugs, ensure people receive inhalers they have been trained to use (for example, by specifying the brand and inhaler in prescriptions) (2018) Spacers and nebulisers For further information, please refer to our Guidelines summary online at: guidelines. co.uk/nice/copd Oral therapy Please refer to our Guidelines summary online at: guidelines.co.uk/nice/copd for recommendations on oral: corticosteroids theophylline mucolytic therapy anti-oxidant therapy anti-tussive therapy Oral prophylactic antibiotic therapy (2018) Before starting prophylactic antibiotic therapy in a person with COPD, think about whether respiratory specialist input is needed Consider azithromycin (usually 250 mg three times a week) for people with COPD if they: do not smoke and have optimised non-pharmacological management and inhaled therapies, relevant vaccinations and (if appropriate) have been referred for pulmonary rehabilitation and continue to have one or more of the following, particularly if they have significant daily sputum production: frequent (typically four or more per year) exacerbations with sputum production prolonged exacerbations with sputum production exacerbations resulting in hospitalisation Before offering prophylactic antibiotics, ensure that the person has had: sputum culture and sensitivity (including tuberculosis culture), to identify other possible causes of persistent or recurrent infection that may need specific treatment (for example, antibiotic-resistant organisms, atypical mycobacteria or Pseudomonas aeruginosa) training in airway clearance techniques to optimise sputum clearance) a CT scan of the thorax to rule out bronchiectasis and other lung pathologies Before starting azithromycin, ensure the person has had: an electrocardiogram (ECG) to rule out prolonged QT interval and baseline liver function tests When prescribing azithromycin, advise people about the small risk of hearing loss and tinnitus, and tell them to contact a healthcare professional if this occurs Review prophylactic azithromycin after the first 3 months, and then at least every 6 months Only continue treatment if the continued benefits outweigh the risks. Be aware that there are no long-term studies on the use of prophylactic antibiotics in people with COPD For people who are taking prophylactic azithromycin and are still at risk of exacerbations, provide a non-macrolide antibiotic to keep at home as part of their exacerbation action plan 9

10 Be aware that it is not necessary to stop prophylactic azithromycin during an acute exacerbation of COPD Oral phosphodiesterase-4 inhibitors (2018) For guidance on treating severe COPD with roflumilast, see NICE s technology appraisal guidance on roflumilast for treating chronic obstructive pulmonary disease Oxygen Please refer to our Guidelines summary online at: guidelines.co.uk/nice/copd for recommendations on: long-term oxygen therapy ambulatory oxygen therapy short-burst oxygen therapy Long-term oxygen therapy Consider long-term oxygen therapy for people with COPD who do not smoke and who: have a partial pressure of oxygen in arterial blood (PaO 2 ) below 7.3 kpa when stable or have a PaO 2 above 7.3 and below 8 kpa when stable, if they also have one or more of the following: secondary polycythaemia peripheral oedema pulmonary hypertension (2018) Conduct and document a structured risk assessment for people being assessed for long-term oxygen therapy who meet the criteria above. As part of the risk assessment, cover the risks for both the person with COPD and the people who live with them, including: the risks of falls from tripping over the equipment the risks of burns and fires, and the increased risk of these for people who live in homes where someone smokes (including e cigarettes) Base the decision on whether long-term oxygen therapy is suitable on the results of the structured risk assessment (2018) Do not offer long-term oxygen therapy to people who continue to smoke despite being offered smoking cessation advice and treatment, and referral to specialist stop smoking services (2018) Advise people who are having long-term oxygen therapy that they should breathe supplemental oxygen for a minimum of 15 hours per day (2018) Do not offer long-term oxygen therapy to treat isolated nocturnal hypoxaemia caused by COPD (2018) Short-burst oxygen therapy Do not offer short-burst oxygen therapy to manage breathlessness in people with COPD who have mild or no hypoxaemia at rest (2018) Managing pulmonary hypertension and cor pulmonale Treating pulmonary hypertension (2018) Do not offer the following treatments solely to manage pulmonary hypertension caused by COPD, except as part of a randomised controlled trial: bosentan losartan nifedipine nitric oxide pentoxifylline phosphodiesterase-5 inhibitors statins Treating cor pulmonale (2018) Ensure that people with cor pulmonale caused by COPD are offered optimal COPD treatment, including advice and interventions to help them stop smoking. For people who 11

11 need treatment for hypoxia, see the section on long-term oxygen therapy, page 8 Oedema associated with cor pulmonale can usually be controlled symptomatically with diuretic therapy Do not use the following to treat cor pulmonale caused by COPD: alpha-blockers angiotensin-converting enzyme inhibitors calcium channel blockers digoxin (unless there is atrial fibrillation) Lung surgery and lung volume reduction procedures For further information, please refer to our Guidelines summary online at: guidelines. co.uk/nice/copd Multidisciplinary management COPD care should be delivered by a multidisciplinary team Education There are significant differences in the response of people with COPD and asthma to education programmes. Programmes designed for asthma should not be used in COPD At diagnosis and at each review appointment, offer people with COPD and their family members or carers (as appropriate): written information about their condition opportunities for discussion with a healthcare professional who has experience in caring for people with COPD (2018) Ensure the information provided is: available on an ongoing basis relevant to the stage of the person s condition tailored to the person s needs (2018) At minimum, the information should cover: an explanation of COPD and its symptoms advice on quitting smoking (if relevant) and how this will help with the person s COPD advice on avoiding passive smoke exposure managing breathlessness physical activity and pulmonary rehabilitation medicines, including inhaler technique and the importance of adherence vaccinations identifying and managing exacerbations details of local and national organisations and online resources that can provide more information and support how COPD will affect other long-term conditions that are common in people with COPD (for example, hypertension, heart disease, anxiety, depression and musculoskeletal problems) (2018) Advise people with COPD that the following factors increase their risk of exacerbations: continued smoking or relapse for ex smokers exposure to passive smoke viral or bacterial infection indoor and outdoor air pollution lack of physical activity seasonal variation (winter and spring) (2018) Self-management (2018) Develop an individualised self-management plan in collaboration with each person with COPD and their family members or carers (as appropriate), and: include education on all relevant points from Education, see page 11 review the plan at future appointments Develop an individualised exacerbation action plan in collaboration with each person with COPD who is at risk of exacerbations Offer people a short course of oral corticosteroids and a short course of oral antibiotics to keep at home as part of their exacerbation action plan if: they have had an exacerbation within the last year, and remain at risk of exacerbations they understand and are confident about when and how to take these medicines, and the associated benefits and harms 11

12 Table 5: Summary of follow up of people with COPD in primary care 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 motivation to quit Adequacy of symptom control: breathlessness exercise tolerance estimated exacerbation frequency Need for pulmonary rehabilitation Presence of complications Effects of each drug treatment Inhaler technique Need for referral to specialist and therapy services Smoking status and motivation to quit Adequacy of symptom control: breathlessness exercise tolerance estimated exacerbation frequency Presence of cor pulmonale Need for long-term oxygen therapy Person with COPD s nutritional state Presence of depression Effects of each drug treatment Inhaler technique Need for social services and occupational therapy input Need for referral to specialist and therapy services Need for pulmonary rehabilitation Measurements to make FEV 1 and FVC Calculate BMI MRC dyspnoea score FEV 1 and FVC Calculate BMI MRC dyspnoea score SaO 2 Table 6: Factors to consider when deciding where to treat the person with COPD FACTOR TREAT AT HOME TREAT IN HOSPITAL Able 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 long-term oxygen therapy No Social circumstances Good Living alone/not coping Acute confusion No Yes Rapid rate of onset No Yes Significant comorbidity (particularly cardiac disease and insulin-dependent diabetes) No SaO 2 <90% No Yes Changes on chest radiograph No Present Arterial ph level 7.35 <7.35 Arterial PaO 2 7 kpa <7 kpa Yes Yes 11

13 they know to tell their healthcare professional when they have used the medicines, and to ask for replacements For guidance on the choice of antibiotics, see the NICE guideline on antimicrobial prescribing for acute exacerbations of COPD At all review appointments, discuss corticosteroid and antibiotic use with people who keep these medicines at home, to check that they still understand how to use them. For people who have used three or more courses of oral corticosteroids and/or oral antibiotics in the last year, investigate the possible reasons for this See full guideline for more guidance on oral corticosteroids Encourage people with COPD to respond promptly to exacerbation symptoms by following their action plan, which may include: adjusting their short-acting bronchodilator therapy to treat their symptoms taking a short course of oral corticosteroids if their increased breathlessness interferes with activities of daily living adding oral antibiotics if their sputum changes colour and increases in volume or thickness beyond their normal day-to-day variation telling their healthcare professional Ask people with COPD if they experience breathlessness they find frightening. If they do, consider including a cognitive behavioural component in their self management plan to help them manage anxiety and cope with breathlessness For people at risk of hospitalisation, explain to them and their family members or carers (as appropriate) what to expect if this happens (including non-invasive ventilation and discussions on future treatment preferences, ceilings of care and resuscitation) Telehealth monitoring (2018) Do not offer routine telehealth monitoring of physiological status as part of management for stable COPD Follow-up of people with COPD See table 5, page 12, and guidelines. co.uk/nice/copd for further information Managing exacerbations of COPD Definition of an exacerbation A sustained acute-onset worsening of the person s symptoms from their usual stable state, which goes beyond their normal day-to-day variations. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication Assessing the need for hospital treatment Use the factors in table 6 (see page 12) to assess whether people with COPD need hospital treatment Investigating an exacerbation The diagnosis of an exacerbation is made clinically and does not depend on the results of investigations. However, investigations may sometimes be useful in ensuring appropriate treatment is given. Different investigation strategies are needed for people in hospital (who will tend to have more severe exacerbations) and people in the community 11

14 Primary care For people who have their exacerbation managed in primary care: sending sputum samples for culture is not recommended in routine practice pulse oximetry is of value if there are clinical features of a severe exacerbation Terms used in this guideline Asthmatic features/features suggesting steroid responsiveness This includes any previous, secure diagnosis of asthma or of atopy, a higher blood eosinophil count, substantial variation in FEV 1 over time (at least 400 ml) or substantial diurnal variation in peak expiratory flow (at least 20%) Mild or no hypoxaemia People who are not taking long-term oxygen therapy and who have a mean PaO 2 greater than 7.3 kpa * The Medicines and Healthcare products Regulatory Agency (MHRA) has published advice on the risk of psychological and behavioural side-effects associated with inhaled corticosteroids (2010). The MHRA has published advice on the risk for people with certain cardiac conditions when taking tiotropium delivered via Respimat or HandiHaler (2015). At the time of publication (December 2018), azithromycin did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council s Prescribing guidance: prescribing unlicensed medicines for further information. The MHRA has published an alert on the risk of death and severe harm from failure to obtain and continue flow from oxygen cylinders (2018). Notes NICE Chronic obstructive pulmonary disease in over 16s: diagnosis and management. Available from: NG115. All rights reserved. Subject to Notice of rights (see NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication 11

15 NOTES PREPRINT 11

16 START WITH ANORO (umeclidinium/vilanterol) A once daily LAMA/LABA for symptomatic patients with COPD1 Anoro Ellipta (umeclidinium bromide/vilanterol [as trifenatate]) Prescribing information (Please consult the full Summary of Product Characteristics (SmPC) before prescribing) Anoro Ellipta 55/22mcg (umeclidinium bromide /vilanterol [as trifenatate]) inhalation powder. Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). Indications: Anoro is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Dosage and administration: Inhalation only. One inhalation once daily of Anoro. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate and magnesium stearate). Precautions: Anoro should not be used in patients with asthma. Treatment with Anoro should be discontinued in the event of paradoxical bronchospasm and alternative therapy initiated if necessary. Cardiovascular effects may be seen after the administration of muscarinic receptor antagonists and sympathomimetics therefore Anoro should be used with caution in patients with severe cardiovascular disease. Anoro should be used with caution in patients with urinary retention, narrow angle glaucoma, convulsive disorders, thyrotoxicosis, hypokalaemia, hyperglycaemia and severe hepatic impairment. No dosage adjustment is required in renal or mild to moderate hepatic impairment. Acute symptoms: Anoro is not indicated for acute episodes of bronchospasm. Warn patients to seek medical advice if shortacting inhaled bronchodilator use increases, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken. Interactions with other medicinal products: Avoid β-blockers. Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin). Anoro should not be used in conjunction with other long-acting β2-adrenergic agonists or medicinal products containing long-acting muscarinic antagonists. Caution is advised with concomitant use with methylxanthine derivatives, steroids or non-potassium-sparing diuretics as it may potentiate possible hypokalaemic effect of β2-adrenergic agonists. Fertility, pregnancy, and breastfeeding: No available data. Balance risks against benefits. Side effects: Common ( 1/100 to <1/10): urinary tract infection, sinusitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache, cough, oropharyngeal pain, constipation and dry mouth. Other important side effects include: Uncommon ( 1/1,000 to <1/100) atrial fibrillation, supraventricular tachycardia, rhythm idioventricular, tachycardia, supraventricular extrasystoles, palpitations, and hypersensitivity reactions including rash. Rare ( 1/10,000 to <1/1,000) anaphylaxis, angioedema, and urticaria. Glaucoma, vision blurred, intraocular pressure increased and paradoxical bronchospasm. See SmPC for other adverse reactions. Legal category: POM. Presentation and Basic NHS cost: Anoro Ellipta. 1 inhaler x 30 doses. Anoro Ellipta 55/22mcg Marketing authorisation (MA) no. 55/22mcg 1x30 doses [EU/1/14/898/002]; MA holder: Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK. Last date of revision: July UK/UCV/0095/15(2)b. Anoro and Ellipta are registered trademarks of the GlaxoSmithKline group of companies. All rights reserved. Anoro was developed in collaboration with Innoviva Inc. Adverse events should be reported. Reporting forms and information can be found at or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on Reference: 1. Anoro SmPC Read the clinical data at GlaxoSmithKline Group of Companies. Zinc code: UK/UCV/0029/18 I Date of preparation: December 2018