Rationale and impact

These sections briefly explain why the committee made the recommendations and how they might affect practice. They link to details of the evidence and a full description of the committee's discussion.

Incidental findings on chest X-ray or CT scans

Recommendations 1.1.12 to 1.1.14

Why the committee made the recommendations

The evidence showed that CT scans and chest X‑rays are accurate tests for identifying people who would test positive for COPD using spirometry, including people without symptoms. However, some of the CT and chest X‑ray techniques used in the studies are not routinely used in UK clinical practice. This limited how applicable the evidence was to the NHS, so the committee was unable to make a wider recommendation on using CT scans and chest X‑rays for diagnosing COPD. The committee therefore made recommendations on what to do if a CT scan or X‑ray that was performed for another reason showed signs of emphysema or chronic airways disease.

There was no evidence on what to do for people who have emphysema or signs of chronic airways disease on a CT scan or chest X‑ray, but who have no symptoms. Because of this, the committee made consensus recommendations based on their experience and on current practice in the NHS. The committee also made a research recommendation to find out more about the characteristics of this group, to try to determine whether they differ in ways that might mean standard COPD treatment has to be modified for them.

The committee also reviewed evidence on using pulse oximetry or high-sensitivity C‑reactive protein (hs‑CRP) for diagnosing COPD. They did not recommend these because:

  • pulse oximetry is normally used to measure the severity of COPD rather than to diagnose it, and there are other possible causes of low oxygen saturation

  • elevated hs‑CRP levels are not specifically linked to COPD, and could be caused by other conditions

  • the evidence showed that they were not effective diagnostic tests.

The committee amended the 'Additional investigations' table, based on their knowledge and experience, to more accurately reflect good practice.

How the recommendations might affect practice

As the recommendation only covers CT scans or chest X‑rays taken for other purposes, there would be no additional costs from these tests. The recommendation to consider spirometry and GP respiratory review and the amendments to the 'Additional investigations' table all reflect current practice. There may be a small number of additional referrals for spirometry, but this is expected to have a minimal resource impact.

Full details of the evidence and the committee's discussion are in evidence review D: Diagnosing COPD and predicting outcomes.

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Assessing severity and using prognostic factors

Recommendations 1.1.24 and 1.1.25

Why the committee made the recommendations

The committee recommended against using multidimensional indices, such as BODE, because they were:

  • unable to classify people reliably into high- and low-risk groups better than FEV1 alone or

  • no better at predicting outcomes than FEV1 alone or

  • time-consuming and consisted of components that would not be routinely available in primary care.

However, the committee recognised the need for an effective prognostic tool that did not have these problems, so they made a research recommendation to address this.

The committee used their knowledge and experience to list factors associated with prognosis. In the absence of a single prognostic tool, thinking about these factors can help guide discussions, and help people with COPD to understand how their condition is likely to progress and decide which treatments are right for them.

How the recommendations might affect practice

The BODE index is not used routinely in the NHS and no alternative indices have been recommended, so there should be minimal impact on practice.

Full details of the evidence and the committee's discussion are in evidence review D: Diagnosing COPD and predicting outcomes.

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Inhaled combination therapy

Recommendations 1.2.11 to 1.2.20

Why the committee made the recommendations

Dual therapy

The evidence showed that, compared with other dual therapy combinations and with monotherapy, LAMA+LABA:

  • provides the greatest benefit to overall quality of life

  • is better than other inhaled treatments for many individual outcomes (such as reducing the risk of moderate to severe exacerbations)

  • is the most cost-effective option.

The committee did not recommend a particular LAMA because they were not convinced that the evidence showed any meaningful differences in effectiveness between the drugs in this class. Instead, they updated the existing recommendation on drug and inhaler choice, based on their experience of what factors should be taken into account. In particular, minimising the number and types of inhalers prescribed will make it easier for people to use their inhalers correctly.

Most of the trials specifically excluded people with COPD and asthma, so there was no direct evidence for this group. The committee recommended LABA+ICS based on their clinical experience and knowledge of the likely benefit of inhaled corticosteroids in certain specific COPD phenotypes.

Although the combination therapies recommended in this guideline are the most effective options, some people are currently using different therapies, such as LAMA or LABA monotherapy, and may have their symptoms under control with these. The committee did not want to make people change treatments unnecessarily, so they made a recommendation highlighting that people did not need to switch treatments until their clinical needs changed.

Triple therapy

Not everyone with COPD will benefit from triple therapy. In addition, for some people the symptoms that give them the most problems are caused by other conditions (such as heart failure or anxiety) rather than their COPD. Because of this, a clinical review is needed first, to ensure that people only receive triple therapy if they will benefit from it. The committee envisaged that this review would take the form of a conversation with the person with COPD about their symptoms, rather than relying on tools such as the CAT score or MRC breathlessness score in isolation.

The committee decided that there should be separate recommendations on triple therapy for people who are currently taking LABA+ICS and for people taking LAMA+LABA. They agreed that there was stronger evidence from a greater number of studies that triple therapy benefits people taking LABA+ICS, compared with people taking LAMA+LABA.

For people currently taking LABA+ICS, the evidence showed that LAMA+LABA+ICS reduced the rate of severe exacerbations, improved FEV1, and did not increase the risk of pneumonia or other serious adverse events.

For people currently taking LAMA+LABA, the evidence showed that LAMA+LABA+ICS reduced the rate of serious exacerbations and provides some quality of life improvement. However, these improvements were smaller than the ones for people who were taking LABA+ICS before they started triple therapy. In addition, people who switched from LAMA+LABA to triple therapy were more likely to get pneumonia.

The criteria for starting triple therapy are based on the inclusion criteria for the studies the committee reviewed and their clinical judgement. For people who are currently taking LAMA+LABA, the committee made separate recommendations for:

  • people who are having severe or frequent exacerbations, for whom the benefit of fewer exacerbations outweighs the increased risk of pneumonia

  • people with less severe symptoms, for whom it is less clear if triple therapy provides enough benefits to outweigh the risk of pneumonia.

The 3-month trial is recommended to help identify people in the group with less severe symptoms who will benefit from triple therapy, while ensuring that people who do not benefit can easily switch back to LAMA+LABA. This is to avoid the situation where people continue on triple therapy, with the accompanying risks, without seeing any benefit. As part of the review at the end of the trial, the committee agreed that it was important to explicitly ask the person with COPD if taking the drug had improved their COPD symptoms.

The committee also recommended documenting the reason for continuing ICS, to encourage treatment review so that people are not exposed to the risks of this treatment if they do not benefit from it.

The committee looked at making recommendations for people with asthmatic features. However, the evidence excluded people with asthma and did not provide much information on asthmatic features (such as eosinophil count). Because of this, and because people with asthmatic features are likely to be covered by the recommendation for people taking LABA+ICS, the committee agreed not to make a specific recommendation for this group.

The committee did not make a recommendation in favour of single or multiple inhaler devices as the included evidence did not show a meaningful difference in clinical effectiveness between triple therapy compared to dual therapy based on the number of devices. From the economic evidence, using a single inhaler device was more cost effective, but the committee agreed that there were circumstances where using more than one inhaler to deliver triple therapy may be more appropriate for a particular person with COPD. Finally, the committee had already made a recommendation about the factors to be taken into account when choosing an inhaler device and these included minimising the numbers and types of inhalers where possible and cost so an additional recommendation on this issue was unnecessary.

How the recommendations might affect practice

The recommendation on LAMA+LABA dual therapy is likely to increase the number of people with COPD who are having this treatment. The higher cost of dual therapy compared with monotherapy may result in a significant resource impact, but cost savings are also likely from a reduction in treatments needed for exacerbations (including hospitalisation).

Using LABA+ICS for people with features of asthma/features suggesting steroid responsiveness is in line with current practice.

The recommendations may result in an increase in the number of people who are prescribed triple therapy and an increase in the number of people who need treatment for pneumonia, although this may be mitigated by the relatively widespread current use of triple therapy. However, the criteria for who should be offered triple therapy and the recommendation for a trial period should limit the impact of both of these changes.

Triple therapy regimens have a higher cost than dual long-acting bronchodilator regimens. However, this cost is likely to be at least partially offset by savings from reduced numbers of exacerbations and better management of symptoms for people switching to triple therapy.

It is already routine in practice to have a clinical review before starting triple therapy. The recommendation on clinical review may increase the scope of this review. However, any costs incurred from this should be offset by savings from more optimal management of symptoms in people with COPD, which should be associated with fewer primary care and/ or hospital visits.

The recommendation on how to choose drugs and inhalers covers factors that prescribers routinely consider, so is not a change in practice. However, minimising the number and type of inhaler devices and avoiding unnecessary within-class switching may produce cost savings through lower upfront spending and better symptom control.

Full details of the evidence and the committee's discussion are in evidence review F: Inhaled therapies and evidence review I: Inhaled triple therapy.

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Oral prophylactic antibiotic therapy

Recommendations 1.2.45 to 1.2.53

Why the committee made the recommendations

The evidence showed that prophylactic antibiotics reduce the risk of people having an exacerbation and the number of exacerbations per year in people with COPD and sputum production. However, prescribing these to large numbers of people with COPD could increase levels of antibiotic resistance. Problems with adherence may make this worse, as people are not taking the antibiotics to help with any current symptoms and (for azithromycin) have to remember to take it 3 times a week. In addition, the longest follow-up in the trials was 12 months, so there is no evidence on the long-term effects of prophylactic antibiotics. With this in mind, the committee made recommendations for the people who would benefit the most from prophylactic antibiotics, and whose exacerbations were not being managed well by other treatments.

The committee recommended azithromycin because this antibiotic had the most evidence of effectiveness (based on the numbers of trials and study participants). The recommended dosage is taken from the trials the committee reviewed.

People taking prophylactic azithromycin may also keep antibiotics at home as part of their exacerbation action plan (see recommendation 1.2.126). This should be a different class of antibiotic to ensure that it is effective when they need it, as the person may develop resistance to azithromycin.

The committee recommended strict criteria for using and reviewing prophylactic antibiotics, to ensure that:

  • the risk of antibiotic resistance is minimised, both for the person taking them and for society

  • people only take them if it is safe to do so

  • people do not continue taking them if there is no benefit.

How the recommendations might affect practice

It is likely that these recommendations will increase the number of people taking prophylactic antibiotics. This is unlikely to have a significant resource impact, given the relatively low cost of antibiotics. By reducing exacerbation frequency it is likely to reduce the amount of oral corticosteroids taken by people with COPD.

Full details of the evidence and the committee's discussion are in evidence review E: Predicting and preventing exacerbations.

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Long-term oxygen therapy

Recommendations 1.2.58 to 1.2.63

Why the committee made the recommendations

There is evidence that continuous long-term oxygen therapy improves survival in people with more severe hypoxaemia, but not for people with mild hypoxaemia. The specific thresholds for long-term oxygen therapy are taken from the trials that provided the evidence.

The recommendation that people should use supplemental oxygen for more than 15 hours a day is based on the available evidence. There is also evidence that long-term oxygen therapy was not effective for isolated nocturnal hypoxaemia caused by COPD.

The evidence showed risks of harm from the use of long-term oxygen therapy, in particular burns and fires as a result of smoking while using oxygen and falls from tripping over equipment. Given these risks to the person with COPD and the people they live with, the committee agreed that it is important to conduct a detailed risk assessment before offering this treatment.

The committee decided that there were 2 levels of risk posed by smoking around oxygen and the recommendations they made reflect these differences:

  • People with COPD who do not smoke but who live with people who smoke. Using cigarettes near oxygen could cause fires or burns, but this risk is likely to be lower because the person who smokes can keep away from the oxygen. Oxygen therapy may benefit these people if they meet the eligibility criteria and the risk assessment is favourable.

  • People with COPD who smoke. They will be smoking in close proximity to the oxygen, and the risks to them, the people they live with and their neighbours outweigh the potential benefits of long-term oxygen therapy.

How the recommendations might affect practice

These recommendations may result in an increase in demand for stop smoking services, but these are known to provide good value for money. Additional time may be needed to conduct risk assessments. As these should prevent people from being given oxygen therapy if they would not benefit or may be harmed by it, it would be an appropriate use of resources and should not lead to an overall increase in resource use. These recommendations may also reduce the cost of managing harms associated with oxygen use, including falls, burns and the wider costs of fires.

Full details of the evidence and the committee's discussion are in evidence review B: Oxygen therapy in people with stable COPD.

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Ambulatory and short-burst oxygen therapy

Recommendations 1.2.67 and 1.2.73

Why the committee made the recommendations

The evidence for people with mild or no hypoxaemia showed that neither ambulatory oxygen nor short-burst oxygen provide a clinically meaningful improvement in breathlessness.

How the recommendations might affect practice

Reducing the use of ambulatory and short-burst oxygen therapy in people who would not benefit is likely to be cost saving and will allow resources to be invested in effective treatments for breathlessness instead.

Full details of the evidence and the committee's discussion are in evidence review B: Oxygen therapy in people with stable COPD.

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Managing pulmonary hypertension and cor pulmonale

Recommendations 1.2.77, 1.2.78 and 1.2.80

Why the committee made the recommendations

Pulmonary hypertension

The committee agreed that there was not enough evidence to recommend any of the reviewed treatments for pulmonary hypertension in people with COPD. Although some of the treatments improved blood pressure readings, there was no evidence that they improved quality of life and the clinical trials only involved small numbers of people.

There is a shortage of good evidence in this area, so the committee made an exception for using these treatments in randomised controlled trials, and made a research recommendation.

Cor pulmonale

The evidence on long-term oxygen therapy for people with COPD and cor pulmonale showed no improvement in survival. However, long-term oxygen therapy can also help with hypoxia. The committee saw no evidence that people with cor pulmonale should be treated or assessed for long-term oxygen therapy differently than other people with COPD.

How the recommendations might affect practice

The recommendations will not change practice, as none of the treatments the committee has recommended against for pulmonary hypertension or cor pulmonale are currently in routine use specifically for these conditions in people with COPD.

Full details of the evidence and the committee's discussion are in evidence review A: Managing pulmonary hypertension and cor pulmonale.

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Lung volume reduction procedures, bullectomy and lung transplantation

Recommendations 1.2.88 to 1.2.94

Why the committee made the recommendations

The evidence showed that people with severe COPD show improvements in lung function, exercise capacity, quality of life and long-term mortality as a result of lung volume reduction surgery. The criteria for who should be referred for this procedure are based on the criteria used in the trials reviewed by the committee and the committee's clinical expertise, taking into account current practice in the NHS.

It was not clear from the evidence whether endobronchial coils work better than standard lung volume reduction surgery. In addition, the procedure is relatively new. For these reasons, the committee recommended that it is only offered as part of a clinical trial.

The recommendations on referral for bullectomy and lung transplantation are based on the committee's knowledge and experience. The lung transplantation referral criteria were adapted from the criteria used for the respiratory review for lung volume reduction surgery. The committee noted that some people are refused lung transplantation because they have had previous lung volume reduction procedures. These people could still benefit from transplantation, so the committee made a recommendation to reflect this.

How the recommendations might affect practice

It is current clinical practice to assess for future treatment plans after pulmonary rehabilitation. However, the criteria for referring people to a multidisciplinary team to assess for lung volume reduction assessment have been broadened, as recommended treatment options now include endobronchial valves. The broadening of criteria will lead to more referrals and improved access to these treatments. This will have an impact on resource use, in particular, as a new group of people for whom lung volume reduction surgery was unsuitable may now be treated with endobronchial valves.

Full details of the evidence and the committee's discussion are in evidence review G: Referral criteria for lung volume reduction procedures, bullectomy or lung transplantation.

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Risk factors for COPD exacerbations

Recommendation 1.2.123

Why the committee made the recommendation

The factors associated with exacerbations are taken from the evidence available and the committee's experience. The evidence on physical activity was not reviewed, but as promoting exercise and physical activity is an important part of management for stable COPD the committee agreed to include it. The list only covers the factors that people can avoid or reduce their exposure to. Other factors are also associated with exacerbations (for example, disease-related factors, biomarkers and other medicines), but people cannot avoid these on their own and these factors are addressed in other areas of the guideline.

How the recommendation might affect practice

These recommendations are unlikely to have a significant impact on resources, as the marginal cost of providing advice on exacerbations to people with COPD is very low. An increased emphasis on physical activity may lead to an increase in referrals to pulmonary rehabilitation, which is known to be a highly cost-effective intervention for people with COPD. The recommendations may produce some cost savings by reducing the number of exacerbations people have.

Full details of the evidence and the committee's discussion are in evidence review E: Predicting and preventing exacerbations.

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Self-management, education and telehealth monitoring

Recommendations 1.2.119 to 1.2.121 and 1.2.124 to 1.2.133

Why the committee made the recommendations

Evidence showed that self-management plans improve quality of life and reduce hospital admissions. The committee recommended that self-management plans include:

  • patient education, because this was a common component of the self-management plans they examined and because education alone was shown to improve knowledge about COPD

  • cognitive behavioural components for people with frightening breathlessness, because there is some evidence that these reduce distress (although they do not help with the symptoms of breathlessness).

The list of topics to be covered in information about COPD is taken from the self-management plans the committee examined and their own clinical and personal experience.

Exacerbation action plans were shown to improve quality of life and reduce hospital admissions for people at risk of exacerbations. Most of the exacerbation action plans that the committee examined provided people with short courses of antibiotics and corticosteroids to use at home to respond to symptoms, and monitoring to make sure they were using those medicines appropriately. Therefore these components were included in the recommendations. The committee also discussed the potential for antibiotic overuse, and stressed the importance of continued monitoring to ensure people are using these medicines appropriately.

Telehealth monitoring does not improve quality of life or reduce hospitalisations for people with COPD, and it leads to higher costs. However, the committee did not want to prevent telehealth monitoring being used for specific reasons that were not covered in the evidence they reviewed, such as short-term monitoring following hospital discharge, so they only recommended against routine telehealth monitoring.

How the recommendations might affect practice

Self-management plans are already in place for some people with COPD. The recommendations may change the content of these plans, and may increase the number of people using a self-management plan. However, self-management plans are highly cost effective and the increased cost of providing them should be offset by cost savings from a reduction in hospitalisations.

The number of people with stable COPD who are having telehealth monitoring should decrease, which is likely to reduce costs.

Full details of the evidence and the committee's discussion are in evidence review C: Self-management interventions, education and telehealth monitoring.

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Duration of oral corticosteroids for managing exacerbations

Recommendation 1.3.16

Why the committee made the recommendations

There are risks associated with long-term corticosteroid use, so it is important to use the shortest effective treatment duration. Treatment is recommended for 5 days because the evidence showed no benefit from taking corticosteroids for more than 7 days and shorter courses of 5 days are routinely used in clinical practice already. The 2019 review did not look at corticosteroid doses, so the dose from the original 2004 recommendation was retained.

How the recommendations might affect practice

The recommendation may reduce the amount of corticosteroids used in clinical practice, which may result in a cost saving. However, the overall impact is likely to be small because oral corticosteroids are cheap, and because prescribing corticosteroids for 5 days is current practice for many clinicians.

Full details of the evidence and the committee's discussion are in evidence review J: Length of corticosteroid use during exacerbations.

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  • National Institute for Health and Care Excellence (NICE)