Dr Kevin Gruffydd-Jones outlines the revised NICE COPD guideline recommendations on post-bronchodilator spirometry, assessment of disease severity, and inhaled therapy

Chronic obstructive pulmonary disease (COPD) exerts a heavy toll on the individual patient and on the health economy of the United Kingdom. Over 3 million people are estimated to have the disease (900,000 diagnosed and 2 million undiagnosed),1 resulting in over 30,000 deaths per annum.

The 2010 NICE guideline on Management of chronic obstructive pulmonary disease in adults in primary and secondary care (Clinical Guideline 101)1 is a partial update of the original version published in 2004 (Clinical Guideline 12).2

There has been increasing recognition that COPD is not just a disease of the lungs, but also has systemic effects (e.g. depression, muscle wasting). In addition there have been several large-scale clinical trials published since 2004, principally looking at the efficacy of pharmacotherapy in stable COPD.3–5 This has led to new recommendations on:1

  • diagnostic and assessment criteria
  • a new algorithm for inhaled therapy (see Figure 1)
  • the value of early pulmonary rehabilitation post-hospital discharge.
Figure 1: Use of inhaled therapies for chronic obstructive pulmonary disease1

National Institute for Health and Care Excellence (NICE) (2010) CG101. Chronic obstructive pulmonary disease. London: NICE. Reproduced with permission. Available from: www.nice.org.uk/guidance/CG101


A diagnosis of COPD should be considered in a patient aged 35 years and over who has a risk factor (e.g. smoking, occupation) and presents with one or more of the following:1

  • exertional breathlessness
  • chronic cough
  • regular sputum production
  • frequent winter ‘bronchitis’
  • wheeze.

The diagnosis of COPD is made on the basis of the presence of characteristic symptoms (e.g. cough, breathlessness) and signs and the demonstration of airflow obstruction on spirometry (i.e. post-bronchodilator ratio of forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] <0.7).1

It should be emphasised that the diagnosis of COPD is not based solely on spirometry, which is used to confirm the presence of airway obstruction, but on the healthcare professional using signs (e.g. clubbing, basal lung crackles) and investigations (e.g. chest X-ray) to exclude alternative pathology.1

The original NICE guideline recommendations were unclear as to whether pre- or post-bronchodilator spirometry values should be used,2 but the Guideline Development Group (GDG) found that post-bronchodilator readings had a higher positive predictive value for COPD than pre-bronchodilator readings.1 This is in line with the use of post-bronchodilator readings in the quality and outcomes framework (QOF)6 and with international guidelines.7 The implication of this in practice is that patients should be asked to omit any inhaled bronchodilator therapy for at least 4 hours prior to diagnostic spirometry. The actual dosage of beta2 agonist needed for bronchodilation is not stated in the NICE guideline, but administration of salbutamol 100 ?g in four separate puffs via a metered dose inhaler and spacer has been recommended in standards published for primary care spirometry.8

Airway obstruction
The severity of airway obstruction is determined by the FEV1 % predicted. The 2004 NICE guideline was out of phase with international definitions of severity and has been amended as shown in Table 1. Two points should be emphasised:1

  • the table reflects the severity of airflow obstruction not the degree of disease severity (see below)
  • patients who have a predicted FEV1 ?80% and a FEV1/FVC ratio of <0.7 would formerly not have been considered as having COPD under the 2004 NICE guideline. There is evidence that asymptomatic patients in this group do not have an accelerated decline in health and disease status (i.e. they do not have a worse prognosis) than control patients without airways obstruction, and therefore a diagnosis of COPD should only be made in patients with FEV1/FVC ratio <0.7 and FEV1 predicted ?80% if characteristic symptoms are present.
Table 1: 2010 NICE guideline grading of severity of airflow obstruction1
Severity FEV1 % predicted
Stage 1—mild ?80*
Stage 2—moderate 50–79
Stage 3—severe 30–49
Stage 4—very severe <30†
*Symptoms should be present to diagnose COPD in people with mild airflow obstruction
Or FEV1 <50% with respiratory failure
COPD=chronic obstructive pulmonary disease; FEV1=forced expiratory volume in 1 second
National Institute for Health and Care Excellence (NICE) (2010) CG101. Chronic obstructive pulmonary disease. London: NICE. Reproduced with permission. Available from: www.nice.org.uk/guidance/CG101

Assessment of disease severity

Traditionally, disease severity has been equated with the degree of airflow obstruction. However, the severity of airflow obstruction relates poorly to disability and a more comprehensive assessment of severity should also include other known prognostic factors such as the Medical Research Council (MRC) dyspnoea score (see Table 2), health status, and frequency of exacerbations.1 Multidimensional questionnaires on severity and health status are being developed for primary care,9,10 but were not reviewed by NICE.

Table 2: Medical Research Council dyspnoea score1
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 m or after a few minutes on level ground
5 Too breathless to leave the house, or breathless when dressing or undressing
Fletcher C, Elmes P, Fairbairn A et al. Significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. Br Med J 1959; 2: 257–266. Reproduced with permission.


In recent years there have been several large-scale studies looking at the effect of inhaled pharmacotherapy on control of COPD in terms of the impact not only on patient symptoms and quality of life, but also the effect of reducing future risk of exacerbations, mortality, and disease progression. These studies have led to changes in the guideline recommendations concerning the role of various inhaled drugs.1 These are summarised in the treatment algorithm shown in Figure 1.

Patients should receive short-acting bronchodilators (e.g. salbutamol or ipratropium) for relief of intermittent breathlessness. The first choice of treatment for persistent breathlessness and prevention of exacerbations is determined by the level of FEV1 post-bronchodilator.

The NICE guideline recommends that if FEV1 is:1

  • ?50% predicted—use a long-acting anti-muscarinic agent (LAMA)
    (e.g. tiotropium) or a long-acting beta2 agonist (LABA) (e.g. salmeterol or formoterol)
  • <50% predicted—the initial choice is between a LAMA or LABA/inhaled corticosteroid (ICS) in a combination inhaler. In the presence of persistent symptoms or exacerbations, triple therapy with ICS/LABA in a combination inhaler and LAMA is recommended.

Where there is a choice of therapy, NICE does not recommend which specific drug should be used, but stated that this should be based on symptomatic response, potential to reduce exacerbations, patient preference, cost, and inhaler technique.1

In spite of the update on inhaled pharmacotherapy, the NICE guideline continues to emphasise the importance of a patient-centred holistic approach to management. This has been summarised and adapted for use in primary care by the Primary Care Respiratory Society (UK) and is shown in Figure 2.11

All patients with COPD should be encouraged to stop smoking, and offered help with pharmacological interventions (nicotine replacement therapy, bupropion, and varenicline).12

Figure 2: The PCRS UK patient-centred approach to COPD management in primary care11
figure2PCRS=Primary Care Respiratory Society; COPD=chronic obstructive pulmonary disease; BMI=body mass index; MRC=Medical Research Council; FEV1=forced expiratory volume in 1 second


Reprinted with permission from Primary Care Respiratory Society UK. Diagnosis and Management of COPD in Primary Care. Dr Kevin Gruffydd-Jones. Available at: www.pcrs-uk.org/resources/copd_guidelinebooklet_final.pdf. This image is the copyright of PCRS-UK and Dr Kevin Gruffydd-Jones. 2010.

 Pulmonary rehabilitation

Pulmonary rehabilitation has been shown to improve health status and levels of activity and reduce hospital stay. It should be offered to all patients with COPD who have functional limitation as a result of their condition (usually an MRC dyspnoea score of 3 and above). In addition, pulmonary rehabilitation should be considered in patients recently admitted to hospital with an exacerbation of COPD as it has been shown to reduce the risk of readmission.


The 2010 update of the NICE guideline on COPD clarifies the use of measuring airways obstruction when making a diagnosis of COPD, and its role in the assessment of disease severity. Similarly, the role of various inhaled pharmacotherapies is updated. However, the guideline emphasises that COPD is more than just a disease of the lungs, but has systemic manifestations that need a multidimensional approach to assessment and management.


This work was undertaken by Kevin Gruffydd-Jones, a member of the COPD GDG, which received funding from the National Institute for Health and Care Excellence. The views expressed in this publication are those of the authors and not necessarily those of the Institute.

NICE implementation tools

NICE has developed the following tools to support implementation of Clinical Guideline 101 on Management of chronic obstructive pulmonary disease in adults in primary and secondary care (partial update).They are now available to download from the NICE website: www.nice.org.uk.

Slide set
The slides are aimed at supporting organisations to raise awareness of the guideline and resulting implementation issues at a local level, and can be edited to cater for local audiences. This information does not supersede or replace the guidance itself.

Baseline assessment tool
The baseline assessment is an Excel spreadsheet that can be used by organisations to identify if they are in line with practice recommended in NICE guidance and to help them plan activity that will help them meet the recommendations.

  1. National Clinical Guideline Centre. Chronic obstructive pulmonary disease: management of chronic obstructive pulmonary disease in adults in primary and secondary care. London: National Clinical Guideline Centre, 2010. Available at: www.rcplondon.ac.uk/clinical-standards/ncgc/Pages/published-guidelines.aspx
  2. National Institute for Clinical Excellence. Chronic obstructive pulmonary disease: Management of chronic obstructive pulmonary disease in primary and secondary care. Clinical Guideline 12. London: NICE, 2004.
  3. 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.
  4. Szafranski W, Cukier A, Ramirez A et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003; 21 (1): 74–81.
  5. Tashkin D, Celli B, Senn S wt al; UPLIFT Study Investigators. A 4 year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359 (15): 1543–1554.
  6. British Medical Association, NHS Employers. Quality and outcomes framework guidance for GMS contract 2009/10. London: BMA, NHS Employers, 2009. Available at: www.bma.org.uk/employmentandcontracts/independent_contractors/quality_outcomes_framework/qof0309.jsp?page=1
  7. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management and prevention of chronic obstructive pulmonary disease. GOLD, 2009. Available at: www.goldcopd.com
  8. Levy M, Quanjer P, Booker R et al; General Practice Airways Group. Diagnostic spirometry in primary care: Proposed standards for general practice compliant with American Thoracic Society and European Respiratory Society recommendations: a General Practice Airways Group (GPIAG)1 document, in association with the Association for Respiratory Technology & Physiology (ARTP)2 and Education for Health3: 1 www.gpiag.org; 2 www.artp.org; 3 www.educationforhealth.org.uk. Prim Care Respir J 2009; 18 (3): 130–147.
  9. Jones R, Donaldson G, Chavannes N et al. Derivation and validation of a composite index of severity in chronic obstructive pulmonary disease: the DOSE Index. Am J Respir Crit Care Med 2009; 180 (12): 1189–1195.
  10. Jones P, Harding G, Berry P et al. Development and first validation of the COPD Assessment Test. Eur Respir J 2009; 34 (3): 648–654 (www.catestonline.org).
  11. Primary Care Respiratory Society. Diagnosis and management of COPD in primary care. PCRS UK, 2010. www.pcrs-uk.org.
  12. National Institute for Health and Care Excellence. Smoking cessation services in primary care, pharmacies, local authorities and workplaces, particularly for manual working groups, pregnant women and hard to reach communities. Public Health Guidance 10. London: NICE, 2008. Available at: www.nice.org.uk/guidance/PH10 G