Professor Dave Singh summarises the 2017 GOLD recommendations for the diagnosis, assessment, and treatment of chronic obstructive pulmonary disease

IMPORTANT INFORMATION

Post-publication amendment: 28 April 2017

This article was originally printed in the February 2017 issue of Guidelines in Practice. The following amendment has been made to this online version:

  • the first bullet in the commissioning messages, which referred to costs and preferences of LABA/ICS and LABA/LAMA medicines, has been removed as it was felt to be misleading.

Notice about off-licence recommendations

It should be noted that recommendations made by the GOLD Committee for use of any medication are based on the best evidence available from the published literature and not on labelling directives from government regulators. Readers are strongly advised to refer to the GOLD report and the individual summaries of product characteristics for further information and recommendations regarding the use of pharmacological therapies.

Some of the medicines discussed in this article currently (April 2017) do not have UK marketing authorisation for the indications mentioned. 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 guidance on Good practice in prescribing and managing medicines and devices for further information.

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Read this article to learn more about:

  • why the refined GOLD ‘ABCD’ assessment tool separates spirometric grades from the ‘ABCD’ groups
  • how ‘ABCD’ groups and their recommended treatments are based exclusively on patient symptoms and history of exacerbations
  • inhaler technique, self-management, pulmonary rehabilitation, and co-morbidities.

Key points

GP commissioning messages

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Chronic obstructive pulmonary disease (COPD) is usually caused by cigarette smoking. The global burden of COPD is estimated at approximately 400 million cases,1,2 with epidemiological studies showing that 11.7% of the world’s adult population have this condition.1 COPD is a leading cause of mortality worldwide, causing approximately 3 million deaths per year.2,3 These estimates for prevalence and mortality are predicted to increase over the next decade, as smoking rates increase in developing countries and the ageing population increases in higher income countries.2

The symptoms experienced by patients with COPD include persistent dyspnoea, cough, sputum production, wheeze, reduced exercise performance, and fatigue. Patients may also experience muscle wasting, and there is a high prevalence of co-morbidities including cardiovascular disease, osteoporosis, anxiety, and depression. An exacerbation is an acute worsening of symptoms, often caused by infection. Exacerbations vary in severity, with some events resulting in hospitalisation or death.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document4 provides recommendations based on clinical evidence for the management of COPD. This document is not a guideline, but serves as a practical guide for healthcare professionals to follow when diagnosing and managing patients. The GOLD management strategy document is updated at 5-year intervals with companion updates in between, to incorporate any new evidence. This article summarises the key points of the GOLD 2017 revision (‘GOLD 2017’, available at www.goldcopd.org), focusing on the diagnosis, assessment, and treatment of COPD.4 Summaries of new recommendations and issues can be found on p.xii and pp.3–4 of the GOLD 2017 report.

Definition and diagnosis

COPD is defined as a disease characterised by persistent respiratory symptoms and airflow limitation that is usually caused by significant exposure to noxious particles or gases.4 The diagnosis of COPD aligns to the definition, and should be considered in individuals with typical symptoms and a history of exposure to risk factors. The presence of airflow obstruction should be confirmed by post-bronchodilator spirometry. A practical guide to making a diagnosis of COPD is shown in Figure 1 (below). The diagnosis of COPD in clinical practice requires all three criteria to be met (symptoms, history of exposure, and spirometry).4

Algorithm illustrating how to make a diagnosis of COPD

Figure 1: How to make a diagnosis of COPD4

Source: Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. GOLD, 2017.

Adapted from Global Initiative for Chronic Obstructive Lung Disease (GOLD). Reproduced with permission

The symptoms of COPD can vary greatly between patients. Dyspnoea is a very common symptom, but the presence and severity of cough and sputum production varies greatly between individuals, and may not be an important feature.

The proper interpretation of spirometry requires good quality measurements. In the author’s clinical experience, a common problem is that the forced vital capacity (FVC) has not been fully completed, resulting in a falsely low FVC and consequently falsely high forced expiratory volume in 1 second (FEV1)/FVC ratio.

The degree of bronchodilator reversibility does not influence the diagnosis of COPD; patients with asthma and patients with COPD can both have bronchodilator reversibility. A source of historic confusion is that COPD has been labelled a ‘poorly reversible condition’; this means that the pathophysiology of COPD cannot be fully reversed, even with optimum treatment. This concept of a ‘poorly reversible condition’ is completely different to the degree of ‘bronchodilator reversibility’.

Assessment

Once the diagnosis has been made, then a clinical assessment should be performed that focuses on the following four features:

  • severity of airflow obstruction
  • burden of symptoms
  • exacerbation history (which predicts future exacerbation risk5)
  • co-morbidities.

Spirometry is required in order to understand the severity of airflow obstruction, which is graded as shown in Table 1 (below). The severity of airflow obstruction is a prognostic measurement, as it is an important determinant of mortality.4

Table 1: Assessment of severity of airflow obstruction4

ClassificationFEV1 (% predicted)
GOLD 1 ≥80
GOLD 2 50–79
GOLD 3 30–49
GOLD 4 <30
FEV1 =forced expiratory volume in 1 second; GOLD=Global Initiative for Chronic Obstructive Lung Disease

Symptoms should be assessed using either the modified Medical Research Council (mMRC) questionnaire6 or the COPD Assessment Test (CAT).7 The mMRC questionnaire measures dyspnoea using a simple grading scale from 0–4. However, the complexity of COPD symptoms means that important symptoms beyond dyspnoea are not captured by the mMRC grade. The CAT contains eight questions regarding health status that provide a wider assessment of symptoms.

GOLD 2017 uses symptoms and exacerbations to categorise patients into four groups (A,B,C,D), with each group having different pharmacological treatment recommendations (see Figure 2, below). ‘Frequent exacerbators’ are patients with two exacerbations requiring oral corticosteroids and/or antibiotics, or one hospitalisation, in the past year; these patients are classified as group C or D and they have a higher risk of future exacerbations.5 Patients with more symptoms (mMRC ≥2 or CAT ≥10) are classified as group B or D.

Figure showing how ABCD assessment is used to determine pharmacological treatment in COPD

Figure 2: GOLD ABCD assessment

Reprinted with permission of the American Thoracic Society. Copyright © 2017 American Thoracic Society. Singh D, Roche N, Halpin D. Current controversies in the pharmacological treatment of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2016; 194 (5): 541–549.

The American Journal of Respiratory and Critical Care Medicine is an official journal of the American Thoracic Society.

GOLD 2011 used FEV1 in addition to symptoms and exacerbations to classify patients into groups A–D. In clinical practice, pharmacological treatment should be targeted towards the relief of symptoms and prevention of exacerbations. The FEV1 measurement is only weakly related to the burden of symptoms on an individual basis, so treatments for symptomatic relief should be guided by the level of symptoms, not FEV1. Additionally, pharmacological treatments for the prevention of future exacerbations should use the past exacerbation history as a predictor of future events. GOLD 2017 therefore states that the severity of FEV1 abnormality should not influence the majority of pharmacological treatment decisions. FEV1 measurements are helpful for monitoring disease worsening during long-term follow up.

Pharmacological management of COPD

General principles

An individualised approach is needed for the pharmacological management of patients with COPD, focusing on the relief of symptoms and the prevention of future exacerbations. Each GOLD group (A–D) has a recommended initial treatment, with suggested algorithms for follow-up treatment, which involve both escalation and de-escalation of treatment. De-escalation is proposed in situations where it is felt that a treatment was ineffective, or when patients are over-treated. The majority of COPD treatments are inhaled therapies, as these increase delivery to the lungs and minimise systemic exposure that may cause side-effects.

The GOLD recommendations are partially based on clinical evidence from randomised controlled trials, but also incorporate expert opinion where clinical evidence is not conclusive or where there is little clinical evidence. The lack of conclusive evidence for (many) GOLD recommendations means that the emergence of new clinical evidence may change the GOLD management strategy.

Group A and B

Patients in group A and B should be treated with bronchodilators. These patients are at low risk of exacerbations, so inhaled corticosteroids (ICS) are not needed; ICS should only be used in patients with a history of frequent exacerbations (GOLD groups C and D; see Figure 2, above).

Beta-agonists and muscarinic antagonists are bronchodilator classes that can be prescribed as short-acting drugs ‘as required’ or long-acting drugs on a regular basis. In general, the use of short-acting bronchodilators only (without long-acting bronchodilators) is reserved for patients in group A with few symptoms. However, many patients in group A and all in group B require regular treatment with long-acting bronchodilators, which improve lung function, symptoms, and exercise performance, in addition to reducing exacerbation rates.8,9 Long-acting beta agonists (LABAs) or long-acting muscarinic antagonists (LAMAs) may be used.

Combination inhalers containing both a LABA and LAMA can be used as a step-up treatment for patients in GOLD group B who have significant dyspnoea despite long acting bronchodilator monotherapy. Clinical trials have shown that LABA/LAMA combination inhalers have a greater effect on lung function and symptoms compared with long-acting bronchodilator monotherapies.10 The LABA/LAMA combination inhalers may also be considered for initial treatment in patients with more severe symptoms.4

When a second long-acting bronchodilator treatment has been added, it is important to assess the clinical response. If there has been no improvement in symptoms, then de-escalation to monotherapy should be considered. The choice of inhaler device should also be re-evaluated (see under heading ‘Inhaler devices’, overleaf).

Group C and D

Patients in groups C and D are at high risk of exacerbations; in clinical practice, most patients with a high symptom burden will be classified as group D as well.11

For group C patients, initial therapy should be a LAMA, as these drugs address symptoms and exacerbations.8 LAMA treatment also has a greater effect on exacerbations compared with LABA treatment.12 If exacerbations persist at follow up, then a second long-acting bronchodilator can be added (LABA/LAMA), or the patient can be switched to a LABA/ICS combination.

For patients in group D, GOLD recommends that LABA/LAMA should be the initial treatment. For some patients, LAMA monotherapy may be a sufficient initial treatment. LABA/ICS combinations may be considered as initial therapy for patients in group D with features of asthma. LABA/ICS combinations reduce exacerbations, and improve lung function and quality of life.9,13

The position of LABA/LAMA treatment for patients in group D is more prominent compared with the previous GOLD version, and it is the preferred option over LABA/ICS treatment. This positioning is based on evidence that LABA/LAMA treatments reduce exacerbations and improve symptoms to a greater extent than long-acting bronchodilator monotherapy,14 and a single study showing a greater effect of LABA/ LAMA compared with LABA/ICS in patients with a history of exacerbations in the previous year.15 Furthermore, there are concerns about the potential for ICS to cause side-effects, including pneumonia, osteoporosis, and cataracts.4,13,16,17

For patients who still experience exacerbations while on either LABA/LAMA or LABA/ICS, then a step up to triple therapy (LABA/LAMA/ICS) can be considered.4,18 Alternatively, switching from one dual combination to another can be tried (i.e. LABA/LAMA to LABA/ICS or vice-versa).4

For patients established on triple therapy and still experiencing exacerbations, the two main options outlined by GOLD are to add roflumilast (a phosphodiesterase-4 inhibitor) or to use a macrolide antibiotic.4 Roflumilast is not currently available in the UK,19 while practitioners should be cautious about the long-term use of macrolides due to the potential for antibiotic resistance.

Inhaler devices

Many different types of inhaler devices are available to patients and it is important to consider ease of use when deciding which drug to prescribe. Many patients make errors when using inhalers, so education and training in inhaler device technique is essential. For each individual, it is important to find an inhaler device that can be used properly.

Non-pharmacological management

Education and self-management

Education can change a patient’s knowledge base, but may not change behaviour. Healthcare providers should go further than simply giving advice, by motivating and coaching patients to change their behaviour and develop skills that allow self-management. The important components that can be addressed by self-management are listed in Box 1 (below), and include smoking cessation.

Box 1: Key components of self-management4

Key components of patient self-management in COPD are:

  • modifying behavioural risk factors (e.g. smoking, diet, exercise)
  • monitoring and managing the signs and symptoms
  • maintaining adherence to treatment
  • maintaining contact with healthcare providers
  • managing psychosocial issues.

COPD=chronic obstructive pulmonary disease

Physical activity

Physical activity levels are lower in patients with COPD, and this decrease is associated with increased hospitalisation and mortality rates.20

Individual approaches to encourage physical activity should form part of a self-management plan. Pulmonary rehabilitation should also be considered for patients in groups B, C, and D. Patients in group A may have only mild symptoms, and should be encouraged to exercise as much as possible. It is important that pulmonary rehabilitation programmes are structured but also personalised to account for each individual’s disease characteristics, including the degree of dyspnoea and the presence of co-morbidities. The benefits of pulmonary rehabilitation often decrease over time. Maintenance programmes and encouragement to maintain daily activity levels are important to combat this.

Other aspects of non-pharmacological management

All patients with COPD should receive influenza vaccination. Pneumococcal vaccination should be given to all patients aged 65 years and over with COPD, and to younger patients with significant comorbid conditions such as cardiac disease. Oxygen saturation measurements should be performed with a view to identifying patients for long-term oxygen therapy (SaO2 at or below 88%). Nutritional supplementation may be required for malnourished patients.

Palliative care should be discussed when appropriate, in order to help patients and their families during end of life care. Palliative care can help address difficult issues with symptom control, as well as psychological and social issues.

Co-morbidities

Patients with COPD frequently present with concomitant chronic illnesses. Ageing, smoking, and inactivity contribute to the development of these co-morbidities, while COPD itself can also increase the risk of developing some co-morbidities. Common co-morbidities are cardiovascular disease, skeletal muscle dysfunction, metabolic syndrome, osteoporosis, depression, anxiety, and lung cancer. Patients should be regularly assessed for the presence of co-morbidities in COPD and treated routinely as other patients would be.4

Conclusion

GOLD 2017 provides a simple algorithm for the diagnosis of COPD, allowing most cases to be easily recognised using a combination of symptoms, exposure history, and spirometry. The ABCD assessment enables an individual approach to pharmacotherapy, targeting symptoms and exacerbations. The pharmacological treatment recommendations take the approach that drugs within a class (e.g. LAMAs, LABA/LAMAs and LABA/ICSs) have similar clinical benefits; this is supported by clinical trial evidence. The variety of different inhaler devices available offers choice to patients, making it easier to find a device that suits each patient on an individual basis. GOLD does not deal with cost issues, as these differ between countries. In the UK, the cost of drugs that have similar effects is additionally an important factor when choosing which inhaler to prescribe.

There has been a shift in recent years towards using LABA/LAMA combination inhalers in clinical practice. The majority of evidence for their clinical benefits comes from studies conducted in patient groups with a low exacerbation history, supporting the GOLD recommendation for their use in patients in GOLD group B. The preference for LABA/LAMA over LABA/ICS for patients in GOLD group D is based on a single study showing a greater impact of the former on exacerbations in COPD patients with a history of exacerbations in the previous year.15 Ideally, this study should be repeated with other drugs in these classes before practitioners can be truly confident that LABA/LAMA combinations are a better treatment than LABA/ICS for patients in GOLD group D. There are many clinical trials demonstrating the impact of LABA/ICS combinations on exacerbations9,13 and these drugs remain part of the armoury for treating COPD despite concerns about side-effects. The important point is to make sure that LABA/ICS are only used in patients who have a history of exacerbations.

GOLD offers recommendations on various aspects of non-pharmacological management, with emphasis on empowering patients to improve their self-management and ensuring that physical activity levels are improved and/or maintained. Combining appropriate pharmacological and non-pharmacological strategies, taking into account individual patient characteristics, is the key to optimum COPD treatment.

 

Key points

  • The diagnosis of COPD should be based on symptoms, a history of exposure to risk factors, and confirmation by spirometry
  • Bronchodilator reversibility testing does not help make the diagnosis of COPD
  • The assessment of COPD focuses on symptoms and exacerbations to classify patients into groups A–D
  • FEV1 is needed for diagnosis and severity staging, and monitoring during follow up. FEV1 is not used for the A–D assessment
  • Treatment of groups A and B focuses on symptom improvement using bronchodilators
  • Treatment of groups C and D focuses on symptom improvement and exacerbation prevention using bronchodilators with or without ICS
  • A stepwise approach to treatment is needed. LAMA, LABA/LAMA, and LABA/ICS are all treatments that reduce exacerbations, and can be used in patients in GOLD groups C and D. Step-up to triple therapy may be needed for patients in GOLD group D
  • The key components of non-pharmacological management include smoking cessation, self-management, encouraging physical activity, and vaccinations
  • Co-morbidities are common in patients with COPD, and should be treated appropriately.

COPD=chronic obstructive pulmonary disease; FEV1=forced expiratory volume in 1 second; ICS=inhaled corticosteroid; LAMA=long-acting muscarinic antagonist; LABA=long-acting beta agonist; LABA/LAMA=combination inhaler containing LABA and LAMA; LABA/ICS=combination inhaler containing ICS and LABA; GOLD=Global Initiative for Chronic Obstructive Lung Disease

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GP commissioning messages

written by Dr David Jenner, GP, Cullompton, Devon

  • CCGs
    • could provide education sessions for practice nurses and GPs on GOLD guidance and could consider rationalisation of therapy at COPD reviews with benefits for patients and prescribing budgets
    • should liaise with their local department of public health to ensure smoking cessation services are commissioned and readily available for practices to refer to or provide
  • Local formularies should identify the most cost-effective inhalers in each therapeutic group, and should provide a range of inhalers to allow patients a choice of inhaler type.

GOLD=Global Initiative for Chronic Obstructive Lung Disease; COPD=chronic obstructive pulmonary disease; LABA=long-acting beta agonist; ICS=inhaled corticosteroid

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References

  1. Adeloye D, Chua S, Lee C et al. Global and regional estimates of COPD prevalence: systematic review and meta-analysis. J Glob Health 2015; 5 (2): 020415.
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  3. Lopez A, Shibuya K, Rao C et al. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J 2006; 27 (2): 397–412.
  4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. GOLD, 2017. Available at: goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/
  5. Hurst J, Vestbo J, Anzueto A et al. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010; 363 (12): 1128–1138.
  6. Bestall J, Paul E, Garrod R et al. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax 1999; 54: 581–586.
  7. GlaxoSmithKline. COPD assessment testcatestonline.org (accessed 13 February 2017).
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  9. Calverley P, Anderson J, Celli B et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med 2007; 356 (8): 775–789.
  10. Singh D. New combination bronchodilators for chronic obstructive pulmonary disease: current evidence and future perspectives. Br J Clin Pharmacol 2015; 79 (5): 695–708.
  11. Agustí A, Rennard S, Edwards L et al. Clinical and prognostic heterogeneity of C and D GOLD groups. Eur Respir J 2015; 46 (1): 250–254.
  12. Vogelmeier C, Hederer B, Glaab T et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364 (12): 1093–1103.
  13. Singh D, Corradi M, Spinola M et al. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med 2016; 26: 16030.
  14. Wedzicha J, Decramer M, Ficker J et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med 2013; 1 (3): 199–209.
  15. Wedzicha J, Banerji D, Chapman K et al. Indacaterol-glycopyrronium versus salmeterol-fluticasone for COPD. N Engl J Med 2016; 374 (23): 2222–2234.
  16. Crim C, Dransfield M, Bourbeau J et al. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc 2015; 12 (1): 27–34.
  17. Wang J, Rochtchina E, Tan A et al. Use of inhaled and oral corticosteroids and the longterm risk of cataract. Ophthalmology 2009; 116 (4): 652–657.
  18. Singh D, Papi A, Corradi M et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting ß2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet 2016; 388 (10048): 963–973.
  19. NICE. Roflumilast for the management of severe chronic obstructive pulmonary disease. NICE Technology Appraisal 244. NICE, 2012. Available at: www.nice.org.uk/ta244
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