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National Clinical Guideline Centre (UK). Chronic Obstructive Pulmonary Disease: Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care [Internet]. London: Royal College of Physicians (UK); 2010 Jun. (NICE Clinical Guidelines, No. 101.)
In December 2018, NICE updated and replaced this guideline with NICE guideline NG115 on chronic obstructive pulmonary disease (COPD) in over 16s: diagnosis and management. The December 2018 update saw the expert committee review the evidence on diagnosis and prognosis, inhaled combination therapies, prophylactic antibiotics, oxygen therapy, managing pulmonary hypertension and cor pulmonale, lung surgery and lung volume reduction procedures, education, self-management and telehealth monitoring for COPD. A further update then took place in July 2019 where the evidence on inhaled triple therapy for stable COPD and systemic corticosteroids for managing exacerbations was reviewed. This document preserves evidence reviews and committee discussions for areas of the guideline that were not updated in 2018 or 2019.
Chronic Obstructive Pulmonary Disease: Management of Chronic Obstructive Pulmonary Disease in Adults in Primary and Secondary Care [Internet].
Show details1.1. Definition of chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD) is characterised by airflow obstruction. The airflow obstruction is usually progressive, not fully reversible and does not change markedly over several months. The disease is predominantly caused by smoking.
- Airflow obstruction is defined as a reduced post-bronchodilator FEV1/FVC ratio (where FEV1 is forced expiratory volume in 1 second and FVC is forced vital capacity), such that FEV1/FVC is less than 0.7.
- If FEV1 is ≥ 80% predicted normal, a diagnosis of COPD should only be made in the presence of respiratory symptoms e.g. breathlessness or cough.
- The airflow obstruction is due to a combination of airway and parenchymal damage.
- The damage is the result of chronic inflammation that differs from that seen in asthma and which is usually the result of tobacco smoke.
- Significant airflow obstruction may be present before the individual is aware of it.
- COPD produces symptoms, disability and impaired quality of life which may respond to pharmacological and other therapies that have limited or no impact on the airflow obstruction.
- COPD is now the preferred term for the conditions in patients with airflow obstruction who were previously diagnosed as having chronic bronchitis or emphysema.
- Other factors, particularly occupational exposures, may also contribute to the development of COPD.
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. These issues are discussed in more detail in the diagnosis section (Section 6).
1.2. Clinical context
An estimated three million people are affected by COPD in the UK. About 900,000 have been diagnosed with COPD and an estimated two million people have COPD which remains undiagnosed1. The symptoms of the disease usually develop insidiously, making it difficult to determine the incidence of the disease. Most patients are not diagnosed until they are in their fifties.
1.2.1. Prevalence
Because it is defined by airflow obstruction, questionnaire surveys cannot be used to identify patients with COPD. In the last 20 years, only one national study has measured airway function in patients aged 18-65 in the UK. Overall 10% men and 11% women had an abnormally low FEV1 2. A postal study3 with hospital assessment in Manchester in patients aged 45 and over suggested prevalence of non-reversible chronic airflow obstruction in 11%. Half of these individuals had not previously been diagnosed.
In a primary care population aged 45 and over in the UK, screened opportunistically, the prevalence of an abnormal FEV1 and respiratory symptoms was around 9%4. Prevalence increases with increasing age5 and there are significant geographic variations in the prevalence of COPD.
Unlike many other common chronic diseases the prevalence of COPD has not declined in recent years. Prevalence rates appear to be increasing steadily in women but have reached a plateau in men6.
The rate of COPD in the population is estimated at between 2% and 4%, representing between 982,000 and 1.96 million people in England1. The diagnosed prevalence of COPD is 1.5% of the population in 2007/08 according to the Quality Outcome Framework (QOF) statistical bulletin1.
Approximately 835,000 people in England have been diagnosed with COPD in 2008-97. However it is currently estimated that over 3 million people have the disease and that an estimated 2 million have undiagnosed COPD, among whom it is considered that 5.5% will have COPD at the mild end of the spectrum8
Estimates of the prevalence of COPD in the UK vary widely, depending on the criteria that are used. Data from the Quality and Outcomes Framework (QOF)9 for GPs suggest that the majority of general practices can produce a register of patients with COPD amounting to 710,000 people on COPD, although these registers may be incomplete.
COPD is closely associated with levels of deprivation - rates of COPD are higher in more deprived communities1,10.
Estimates based on pre-bronchodilator lung function measurements, as reported from the HSE 2001 data set, are likely to represent an overestimate of the prevalence of COPD in the population. This overestimate will be more evident in the mild and moderate severity stages, with little difference in estimates for prevalence in the severe and very severe COPD groups.
1.2.2. Mortality
It is difficult to be certain of the true mortality rate due to COPD. Some patients die with the disease rather than because of it. Others will die of causes related to COPD, but their death may be certified as being due to these complications11. Analysis of trends in death rates is also complicated by changes in the diagnostic labels.
Chronic obstructive lung disease, mainly chronic obstructive pulmonary disease, is the third largest cause of respiratory death, accounting for more than one fifth (23%) of all respiratory deaths12.
COPD accounts for approximately 30,000 deaths each year in the UK, with more than 90% of these occurring in the over 65 age group in 20041,10,12-14. The rate of mortality for respiratory disease in the UK is almost double the European average. The Health Development Agency estimated in 2004 that around 85% of COPD related deaths could be attributed to smoking.
In men, age standardized mortality rates from COPD have fallen progressively since the 1970s, but in women there has been a small but progressive increase6. All cause mortality is increased in patients with COPD15.
The inpatient mortality rate in 2008 was 7.7% compared with 7.5% in 200316. The overall mortality rate at 90 days was 13.9% in 2008 indicating a reduction from 15.5% in 2003. Of those patients dying within 90 days of admission, fewer succumbed from COPD or its consequences in 2008 (65%) compared to 2003 (71%). Mortality varies between hospitals and is higher in those with fewer respiratory consultants and in those serving more deprived communities. It is thought that up to 25% of patients die within a year1,17,18.
Mortality from COPD in England shows a strong urban rural gradient with high mortality rates in the large conurbations in the North of England19. Mortality reflects social inequalities with men aged 20-64 employed in unskilled manual occupations being 14 times more likely to die from chronic obstructive pulmonary disease than those in professional occupations12. People in urban and deprived areas are more likely to be at risk20.
Cause of death was recorded as COPD in 65% of those who died, a reduction from the 71% observed in 200316. Information on COPD deaths from death certificates significantly under-estimate the burden of disease16,21.
COPD is an important co-morbidity in those dying from other smoking related diseases, most commonly ischaemic heart disease and lung cancer12,22. COPD is the fifth leading cause of death in the UK and fourth worldwide21,23. Moreover, due to an aging population, increases in its prevalence and mortality are expected in the coming decades. COPD is set to become the third leading cause of death worldwide by the year 2020, surpassed only by heart disease and stroke24.
Five year survival from diagnosis is 78% in men and 72% in women with clinically mild disease defined as not requiring continuous drug therapy, but falls to 30% in men and 24% in women with severe disease defined as requiring oxygen or nebulised therapy. The mean age of death of patients with severe COPD is 74.2 years compared with 77.2 years in patients with mild disease and 78.3 years in individuals who did not have COPD15.
1.2.3. Morbidity
An average general practice in the UK which cares for about 7,000 people will have up to 200 people with COPD on its practice list, for many of whom the condition will be undiagnosed. This equates to around 1.4 million consultations with GPs each year, up to four times more than the number of consultations for angina1. COPD patients admitted to hospital are frequent users of primary care in the 12 months prior to their admission.
Three quarters (74%) of admitted patients make contact with their general practice in the month before admission and nearly a third (31%) have 3 or more contacts in those 4 weeks. Although patients make a median of 12 contacts with general practice in the 12 months prior to the audited admission, and have a median of 3 exacerbations, 51% have no contact with out-of-hours services16.
The National COPD Audit 2008 patient survey noted that the majority (83%) of patients report frequent exacerbation of their COPD. Two thirds (68%) of patients reported a respiratory infection or flu-like symptoms in the month prior to admission, about half (57%) noticed a change in colour/volume of phlegm before admission, often 2-5 days before (46%), but with one quarter (26%) having noticed this 6 or more days before. Although 25% of patients admitted with COPD said this was their first admission, 60% had also been admitted to hospital with COPD in the previous 12 months16.
Although only a small proportion of people with COPD are admitted to hospital each year, one in eight (130,000) emergency admissions to hospital is for COPD, making it the second largest cause of emergency admission in the UK, and one of the most costly inpatient conditions treated by the National Health Service (NHS)21. Respiratory disease accounts for 5.2 million bed days, nearly 10% of all hospital bed days. One fifth (21%) of bed days used for respiratory disease treatment are due to chronic obstructive lung disease, such that COPD accounts for more than one million ‘bed days’ each year in hospitals in the UK10,12.
COPD is the most common reason for emergency admission to hospital due to respiratory disease, accounting for the most finished consultant episodes of care (80% of them in those aged over 60 years of age) and is second only to pneumonia in total bed-days per year13 . About 30% of patients admitted with COPD for the first time will be readmitted within three months12.
Admission rates have risen in all age groups since 1994 except in the under 45s. The highest rises have occurred in the over 85s in which rates have almost doubled from 1994 to 2005. www.laia.ac.uk/copd1994-2005.html
Rates of admission to hospital vary by up to five times in different parts of England, reflecting differences in the prevalence of COPD as well as wide variations in the quality of care that is provided in the community1. Risk of hospital admission for the disease varies greatly between regions and within regions.
COPD admissions also show some seasonality and are more common in the winter months25.
The median length of stay in 2008 was 5 days (interquartile range 3-10 days) compared with 6 days in 2003. There has been an increase from 26% to 34% in the proportion of patients having a shorter stay of at most 3 days since 2003. The readmission rate in 2008 was 33%, increased from 31% in 2003. The median time to readmission was 38 days.
There has been an increase in the proportion of admissions that are female so that COPD is now a disease of equal importance in both men and women. The mean age of admissions in 2008 was 73 years for men (increased from 72 years in 2003), and 72 years for women.
90% of patients still live at home, 36% on their own. 39% of patients received some form of personal care at home, whether paid or unpaid. The median % predicted forced expiratory volume in 1 second (FEV1) for those patients with spirometry recorded in the last 5 years was 38%. 67% of recorded Medical Research Council (MRC) dyspnoea scores are Grade 4-5 in the steady state prior to admission the number of current smokers was 33% in 2008 compared with 41% in 200316.
1.2.4. Comorbidities
COPD coexists with other diseases that share tobacco smoking as a risk factor, of which the most common are heart disease and lung cancer26.
Advances in the understanding of COPD have stressed the importance of co-morbidities27. COPD increases the risk for lung cancer, and a recent meta-analysis found a strong inverse relationship between level of lung function and risk of lung cancer. For the same marginal decrease in FEV1, adjusted for smoking, women were twice as likely as men to develop lung cancer28,29.
The National COPD audit showed a very high level of co-morbidity, the association with cardiovascular disease being particularly strong. 51% of the patients had been admitted for COPD within the preceding 24 months16.
The cost and complexity of care escalates with the number of co-morbid conditions30. There is a high frequency of chronic conditions in older adults24,31,32.
1.2.5. Economic impact
The total annual cost of COPD to the NHS in 2000-1 was estimated to be £491,652,000 for direct costs only and £982,000,000 including indirect costs (See Section 14).
Broken down by disease severity according to guidelines at that time, the cost p.a. was
| £149.68 |
| £307.74 |
| £1,307.10 |
The average cost per patient p.a. was £819.42, of which 54.3% was due to inpatient hospitalisation, 18.6% for treatment, 16.4% for GP and specialist visits, 5.7% for accident and emergency visits and unscheduled contacts with the GP or specialist and 5% for laboratory tests33.
The Chief Medical Officer has reported COPD accounts for more than £800 million in direct health care costs10. The direct cost of COPD to the UK healthcare system has been estimated to be between £810-£930m to a year34. More than half of these costs relate to the provision of care in hospital. COPD is among the most costly inpatient conditions treated by the NHS.
The indirect costs of COPD are substantial with an impact on annual productivity amounting to an estimated 24 million lost working days per annum1,10,35. There is little UK data available to quantify other indirect costs such as carer time and inability to carry out non-occupationally related activities13.
Assuming the above estimates for the ‘cost of caring’ is referring to the NHS cost and not the societal cost associated with informal carers, recent DH analysis has estimated the direct cost associated with COPD by disease severity.
- GOLD Stage I (FEV1 ≥ 80% predicted): £120 - £130
- GOLD Stage II (FEV1 50% to 79% predicted): £270 - £290
- GOLD Stage III (FEV1 30% to 49% predicted): £910 - £980
- GOLD Stage IV (FEV1 ≤ 30% predicted): £3,000 - £3,200(see section 6.9, table 6.7)
The estimated cost of an acute episode (exacerbation) in 2004, using the severity classification at that time, ranges from:
- £8 to £15 for a person with mild COPD
- £23 to £95 for a person with mild to moderate COPD
- £1,400 to £1,600 for a person with severe COPD10
As well as these costs, it has been estimated that 21.9 million working days were lost in 1994-5. In a recent survey of a random sample of patients with COPD 44% were below retirement age and 24% reported that they were completely prevented from working by their disease. A further 9% were limited in their ability to work and patients' carers also missed time from work 33.
The symptoms of the disease usually develop insidiously, making it difficult to determine the incidence of the disease. Most patients are not diagnosed until they are in their fifties.
1.3. Original guideline aims
This guideline offers best practice advice on the identification and care of patients with COPD. It aims to define the symptoms, signs and investigations required to establish a diagnosis of COPD. It also aims to define the factors that are necessary to assess its severity, provide prognostic information and guide best management. It gives guidance on the pharmacological and non-pharmacological treatment of patients with stable COPD, and on the management of exacerbations. The interface with surgery and intensive therapy units (ITU) are also discussed.
1.4. Patient choice
Whenever recommendations are made, it is recognised that informed patient choice is important in determining whether or not an individual patient chooses to undergo the investigation or accept treatment that is recommended.
1.5. Underlying guideline principles
The main principles behind the development of this guideline were that it should:
- Consider all issues that are important in the management of people with COPD
- Use published evidence wherever this is available
- Be useful and usable to all professionals
- Take full account of the perspective of the person with COPD and their carers
- Indicate areas of uncertainty or controversy needing further research.
1.6. Structure of the original guideline
The document is divided into sections, which cover a set of related topics. For each topic the layout is similar.
The background to the topic is provided in one or two paragraphs that simply set the recommendations in context.
Then the evidence statements are given and these summarise the evidence, which is detailed in the evidence tables. In addition there is an evidence statement about the health economic evidence where this is available. These evidence statements and tables aim to provide context and aid the reader's understanding of why each recommendation was made.
The evidence statements are followed by consensus statements agreed by the guideline development group. These statements have been made when there is a lack of evidence or where the guideline development group felt that there were important issues which needed commenting on but which lay beyond or outside the current evidence base.
The main recommendations follow. These are graded to indicate the strength of the evidence behind the recommendation.
1.7. Updating a NICE guideline
The National Clinical Guideline Centre for Acute and Chronic Conditions (NCGC-ACC) undertook a review for update three years after publication of the original COPD guideline in concordance with the NICE Guidelines Manual 200736. Literature searches (based upon the original guideline searches) were re-run.
New evidence that had implications for changing recommendations was ascertained. This review of the evidence and the views of healthcare professionals and patients led to NICE commissioning an 18 month partial update of the COPD guideline. The remit and scope of the update are available in appendix G.
The guideline update 2010 has attempted to maintain, as far as possible, the structure and content of the original NICE COPD guideline 2004. Superseded sections have been removed to an appendix K and new sections have been clearly marked and inserted. GRADE methodology was used to assess the quality of clinical research studies for the first time in a NICE update guideline.
Sections and recommendations from the 2004 guideline which have remained unchanged have maintained the old hierarchy of evidence and recommendation grading system in use at that time.
The development of this evidence-based clinical guideline (partial update) draws upon the methods described by the NICE Guidelines Manual36 specifically developed by the NCGC-ACC for each acute and chronic condition guideline.
1.8. Update aim
The aim of the NCGC-ACC is to provide a user-friendly, clinical, evidence-based guideline for the National Health Service (NHS) in England and Wales that:
- Offers best clinical advice for the management and treatment of COPD in adults in primary and secondary care
- Is based on best published clinical and economics evidence, alongside expert interpretation
- Takes into account patient choice and informed decision-making
- Defines the major components of NHS care provision for COPD
- Details areas of uncertainty or controversy requiring further research
- Provides a choice of guideline versions for different audiences.
1.9. Scope
The guideline was developed in accordance with the partial update scope, which detailed the remit of the guideline originating from the Department of Health and specified those aspects of COPD care to be included and excluded.
Prior to the commencement of the guideline development, the scope was subjected to stakeholder consultation in accordance with processes established by NICE in the guidelines manual37. The full update scope is shown in appendix G.
1.10. Audience
The guideline is intended for use by the following people or organisations:
- All healthcare professionals
- People with COPD and their carers
- Patient support groups
- Commissioning organisations
- Service providers.
1.11. Involvement of people with COPD
The NCGC-ACC was keen to ensure the views and preferences of people with COPD and their carers informed all stages of the guideline. This was achieved by:
- Having a person with COPD as a patient representative on the guideline development group (GDG)
- Consulting with the Patient and Public Involvement Programme (PPIP) housed within NICE during the pre-development (scoping) and final validation stages of the guideline.
- Inclusion of patient groups as registered stakeholders for the guideline.
- Securing patient organisation representation from the British Lung Foundation on the guideline development group.
1.12. Guideline limitations
These include:
- NICE clinical guidelines usually do not cover issues of service delivery, organisation or provision (unless specified in the remit from the Department of Health).
- NICE is primarily concerned with Health Services and so recommendations are not provided for Social Services and the voluntary sector. However, the guideline may address important issues related to the interface of NHS clinicians with these sectors.
- Generally, the guideline does not cover rare, complex, complicated or unusual conditions.
It is not possible in the development of a clinical guideline to complete extensive systematic literature review of all pharmacological toxicity. NICE expect the guidelines to be read alongside the Summaries of Product Characteristics.
The guideline usually makes recommendations within medication licence indications. Exceptionally, where there was clear supporting evidence, recommendations, outside the licensed indications have been included. As far as possible where this is the case it is indicated.
1.13. Other work relevant to the guideline
Related NICE guidance:
National Institute for Clinical Excellence. Guidance on the use of zanamivir, amantadine and oseltamivir for the treatment of influenza. NICE technology appraisal guidance. TA58, 2003. This guidance has been replaced by TA168 Influenza - zanamivir, amantadine and oseltamivir (review).
National Collaborating Centre for Acute Care. Nutrition support in adults: Oral nutrition support, enteral tube feeding and parenteral nutrition. National Clinical Guideline Number 32. London: National Collaborating Centre for Acute Care. 2006. http://guidance.nice.org.uk/CG32
National Institute for Health and Clinical Excellence. Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children. NICE clinical guideline 43 (2006). http://www.guidance.nice.org.uk/CG43
National Institute for Health and Clinical Excellence. Anxiety (amended): management of anxiety (panic disorder, with or without agoraphobia, and generalised anxiety disorder) in adults in primary, secondary and community care. NICE clinical guideline 22 (2007). http://www.guidance.nice.org.uk/CG22
National Institute for Health and Clinical Excellence. Varenicline for smoking cessation. TA 123 (2007). Clinical Introduction. http://www.guidance.nice.org.uk/TA123
National Institute for Health and Clinical Excellence. Influenza (prophylaxis) - amantadine, oseltamivir and zanamivir. TA 158 (2008). http://guidance.nice.org.uk/TA158
National Institute for Health and Clinical Excellence. Smoking cessation services: guidance. London: UK: National Institute for Health and Clinical Excellence. PH 10 (2008). http://guidance.nice.org.uk/PH10
National Institute for Health and Clinical Excellence. Influenza - zanamivir, amantadine and oseltamivir (review). 2009. http://guidance.nice.org.uk/TA168
National Institute for Health and Clinical Excellence. Depression: the treatment and management of depression in adults (update). London: UK: National Institute for Health and Clinical Excellence. 2009. http://guidance.nice.org.uk/CG90
National Institute for Health and Clinical Excellence. Depression in adults with a chronic physical health problem: treatment and management. NICE clinical guideline 91 (2009). http://www.nice.org.uk/guidance/CG91
The developer's role and remit is summarised below:
| National Clinical Guidelines Centre for Acute and Chronic Conditions (NCGC-ACC) | The NCGC-ACC was set up in 2009 and is housed within the Royal College of Physicians (RCP). The NCGC-ACC undertakes commissions received from the National Institute for Health and Clinical Excellence (NICE). |
| NCGC-ACC Technical Team | The technical team met approximately two weeks before each GDG meeting and comprised the following members: GDG chair, GDG clinical advisor, Information Scientist, Research Fellow, Health Economist and Project Manager. |
| Guideline Development Group | The GDG met monthly and comprised a multi disciplinary team of health professionals and a person with COPD, who were supported by the technical team. The GDG membership details including patient representation and professional groups are detailed in the GDG membership table at the front of this guideline. |
| Guideline Project Executive (PE) | The PE was involved in overseeing all phases of the guideline. It also reviewed the quality of the guideline and compliance with the DH remit and NICE scope. The PE comprised of: NCGC-ACC Clinical Director; NCGC-ACC Operations Director; NICE Commissioning Manager; Technical Team. |
| Formal consensus | At the end of the guideline development process the GDG met to review and agree the guideline recommendations. |
- Definition of chronic obstructive pulmonary disease
- Clinical context
- Original guideline aims
- Patient choice
- Underlying guideline principles
- Structure of the original guideline
- Updating a NICE guideline
- Update aim
- Scope
- Audience
- Involvement of people with COPD
- Guideline limitations
- Other work relevant to the guideline
- Introduction - Chronic Obstructive Pulmonary DiseaseIntroduction - Chronic Obstructive Pulmonary Disease
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