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Implementing the new joint NICE asthma guidelines

Implementing the new joint NICE asthma guidelines

GP and respiratory expert Dr Andrew Whittamore outlines the key updates in new joint NICE/BTS/SIGN asthma guidelines and advises on how best to implement the changes

NICE has worked with BTS and SIGN to produce a unified guideline on asthma.1 The guidance aims to modernise asthma management, in particular to support more accurate diagnosis and introduce more effective treatment regimens, to improve outcomes for the 5.4 million people in the UK with asthma.

This article will outline some of the key updates for GPs within the guideline and how to put them into practice.

Several recommendations will need time to filter through to the NHS. For example, funding mechanisms will need to catch up with these guidelines so that fractional exhaled nitric oxide (FeNO) testing and spirometry can be made uniformly available to patients. In addition, the current QOF rules on diagnosis are based on an older version of the guidelines.

Key updates in diagnosis

History is key

Although not a new concept, history is made more prominent in the updated guideline. With a solid basis for why we believe someone has asthma, we can improve the specificity of the diagnostic tests we then use to confirm or exclude a diagnosis.

Documenting a clear picture of respiratory symptoms, their triggers and any risk factors for developing asthma is essential because of the variable course of the condition and because we are potentially committing to a sequence of tests to confirm asthma.

Alternative causes of the symptoms should also be explored. Anyone for whom asthma is being considered must be read-coded as having Suspected Asthma, to support future decision making.

A single objective test may be enough for diagnosis

Because there is no perfect test with both a high specificity and high sensitivity for diagnosing asthma, previous guidelines (and thus QOF) have relied on history plus a combination of available tests to increase certainty. This guideline has employed two strategies for simplifying this.

Firstly, as above, it places a greater emphasis on ensuring a good clinical history is taken.

Secondly, it uses a sequential approach to testing, as summarised in Box 1 below and laid out in NICE/BTS/SIGN algorithms for objective diagnostic testing in adults and young people aged 16 and over, and in children aged 5 to 16.

By using a highly specific initial test with a high threshold for positivity (as with FeNO and eosinophil tests) we can be more certain that the initial positive test is correct.

Conversely, most asthma tests have low sensitivity, meaning they have a good chance of providing false-negative results. Therefore, in the event of a negative result we should move to the next test in sequence.

Testing for eosinophilic inflammation

For the majority of people with asthma, symptoms are linked to high levels of eosinophilic inflammation. To identify this, blood eosinophil levels and FeNO are useful. Where there is a positive history, these tests have high specificity at the recommended thresholds (FeNO ≥50ppb in adults, FeNO ≥35ppb in 5-16 year olds, eosinophils ≥upper laboratory threshold, often 0.5×109/L).

FeNO is now recommended as the first line test for adults and children over 5 years, with blood eosinophil count an alternative option in adults. Because of the variable nature of asthma, these tests are more likely to be positive in someone with asthma when they are symptomatic. The guidelines therefore suggest performing these tests at acute presentations where asthma is suspected or as soon as possible after (see below).

NICE/BTS/SIGN Asthma guidance – diagnostic tests

Testing – adults
1. Measure the blood eosinophil count or FeNO level in adults with a history suggestive of asthma. Diagnose asthma if the eosinophil count is above the laboratory reference range or the FeNO level is 50ppb or more.
2. If asthma is not confirmed by eosinophil count or FeNO level, measure bronchodilator reversibility (BDR) with spirometry. Diagnose asthma if the FEV1 increase is 12% or more and 200 ml or more from the pre-bronchodilator measurement (or if the FEV1 increase is 10% or more of the predicted normal FEV1).
3. If spirometry is not available or it is delayed, measure peak expiratory flow (PEF) twice daily for 2 weeks. Diagnose asthma if PEF variability (expressed as amplitude percentage mean) is 20% or more.
4. If asthma is not confirmed by eosinophil count, FeNO, BDR or PEF variability but still suspected on clinical grounds, refer for consideration of a bronchial challenge test. Diagnose asthma if bronchial hyper-responsiveness is present.

Testing – children aged 5 to 16
1. Measure the FeNO level in children with a history suggestive of asthma. Diagnose asthma if the FeNO level is 35ppb or more.
2. If the FeNO level is not raised, or if FeNO testing is not available, measure BDR with spirometry. Diagnose asthma if the FEV1 increase is 12% or more from baseline (or if the FEV1 increase is 10% or more of the predicted normal FEV1).
3. If spirometry is not available or it is delayed, measure PEF twice daily for 2 weeks. Diagnose asthma if PEF variability (expressed as amplitude percentage mean) is 20% or more.
4. If asthma is not confirmed by FeNO, BDR or PEF variability but still suspected on clinical grounds, either perform skin prick testing to house dust mite or measure total IgE level and blood eosinophil count.
5. Exclude asthma if there is no evidence of sensitisation to house dust mite on skin prick testing or if the total serum IgE is not raised.
6. Diagnose asthma if there is evidence of sensitisation or a raised total IgE level and the eosinophil count is more than 0.5 x 109/L.
7. If there is still doubt about the diagnosis, refer to a paediatric specialist for a second opinion, including consideration of a bronchial challenge test.

See NICE/BTS/SIGN algorithms outlining objective testing for diagnosis of asthma in people aged 16 and over and in children aged 5 to 16 years for more details.

Asthma is characterised by variable/reversible airflow obstruction

Where tests for inflammation do not confirm asthma in someone with suspected asthma, a test for airflow obstruction should be carried out. Spirometry with bronchodilator reversibility (BDR) is the preferred test here. Because of the variable nature of asthma, these tests are more likely to be positive in someone with asthma when they are symptomatic. The guidelines suggest performing these tests at acute presentations where asthma is suspected or as soon as possible after (see below).

Peak flow has a back-up role

Within the diagnosis section of the NICE/BTS/SIGN asthma guidelines there are two possible uses for peak flow. Firstly, where spirometry is not available or if there are likely to be delays in getting spirometry then a 2-week peak flow diary can be considered. Secondly, in the scenario where the patient is presenting acutely with symptoms suggestive of asthma then peak flow readings before and after bronchodilation can be performed to aid diagnosis.

Diagnosis needs to start during acute presentations

People presenting acutely with a suspected asthma component to their symptoms should be treated as if they have acute asthma. A history should be taken, and documented, to outline why asthma should be suspected, followed by objective tests such as FeNO, blood eosinophil count (adults only), BDR or pre- and post-bronchodilator peak flow readings as above.

All of these tests are more likely to produce a positive test when someone is symptomatic. If testing at this stage is not possible then they should be carried out when their acute symptoms are controlled but bearing in mind that any results when on treatment or when less symptomatic are less likely to be as positive. Primary care, as well as acute settings, will need to consider availability of suitable objective tests for patients presenting with suspected asthma.

Treatment updates

Patients diagnosed with asthma should no longer be prescribed SABA alone

There are clear data that unopposed or excessive use of short acting bronchodilator agonists (SABAs) increases risk of asthma attacks and death.2 The new guidance makes it clear that no patient should be prescribed a SABA without also being prescribed a regular inhaled corticosteroid (ICS). There is also a shift away from SABA use in general.

Key updates to treatment recommendations are summarised in Box 2 below and outlined in the NICE/BTS/SIGN algorithms for treatment of people with asthma aged 12 and over and for treatment in children with asthma aged 5-11.

Formoterol is a LABA which works as rapidly as salbutamol and is as effective in treating acute symptoms. In a combination inhaler with an ICS, when used as a reliever inhaler, the ICS-formoterol relieves the acute symptoms while also addressing the underlying inflammation which causes the symptoms in the first place. This approach allows titration of the preventer medication in line with the variable nature of asthma. This reduces future symptoms and reduces risk especially compared to previous approaches which titrate SABA use and enables untreated inflammation to escalate.

When an inhaler containing ICS-formoterol is prescribed to relieve symptoms, this is known as Anti-Inflammatory Reliever therapy (AIR). When this inhaler is used for both maintenance and relief, this is known as maintenance and reliever therapy (MART). This guideline allows patients to self-titrate between AIR and MART. Most patients will require MART to treat underlying inflammation and keep on top of their symptoms. Patients with infrequent or seasonal symptoms may rotate between AIR and MART. This is a major culture change in treatment approach from previous guidelines and it is essential that everyone in health and care understand it (including community pharmacies and acute care providers such as 111 and 999 services).

There are many different types of inhaler with different drugs, doses and devices. This guideline supports the off-license use of an appropriately-dosed inhaler as long as the patient can use it correctly. This provides greater flexibility for moving patients to a SABA-free regime but does mean that prescribers, especially those signing prescriptions for non-prescribers are comfortable with inhaler choices and off-license prescribing.

As above, the overall evidence behind MART and AIR is that these regimes are safer and more effective than other regimes, and the guideline suggests that people with uncontrolled asthma should be switched. There are other possible benefits for AIR/MART such as: a simpler regime; requirement for fewer inhalers (cheaper); and lower greenhouse emissions. I would suggest offering well-controlled asthma patients on ICS/LABA with SABA to swap to AIR/MART at a routine review, explaining the clinical and non-clinical benefits.

Box 2. Key pharmacological treatment updates

Initial management in newly diagnosed aged 12 and over:

  • Offer low-dose ICS/formoterol combination inhaler as needed for symptom relief (AIR therapy), or
  • If highly symptomatic or with a severe exacerbation, offer low-dose MART in addition to treatment for acute symptoms, eg, oral corticosteroids. Consider stepping down to as-needed AIR therapy using a low-dose ICS/formoterol inhaler at a later date if their asthma is controlled.

Changing treatment regime in patients aged 12 and over:

  • For people with confirmed asthma who are currently using a (SABA) only, change to a low-dose ICS/formoterol combination inhaler used as needed (as-needed AIR therapy).
  • Consider changing treatment to (low- /moderate-dose) MART for people with asthma that is not controlled on:

– regular (low- / moderate-dose) ICS plus SABA as needed
– regular (low- / moderate-dose) ICS/LABA combination inhaler plus SABA as needed
– regular (low- /moderate-dose) ICS and supplementary therapy (LTRA) plus SABA as needed.
– regular (low- /moderate-dose) ICS/LABA combination inhaler and supplementary therapy (LTRA) plus SABA as needed.

Initial management in children aged 5 to 11:

• Offer twice-daily paediatric low-dose ICS, with a SABA as needed, as initial treatment for children aged 5 to 11 years with newly diagnosed asthma.
• Consider paediatric low-dose MART for children with asthma that is not controlled on paediatric low-dose ICS plus SABA as needed, as long as they are assessed to have the ability to manage a MART regimen.
• Consider increasing to paediatric moderate-dose MART if asthma is not controlled on paediatric low-dose MART.

See NICE/BTS/SIGN algorithms for treatment of people with asthma aged 12 and over and for treatment of children with asthma aged 5-11 for more details.

Review and monitoring

Annual review is a minimum

People with asthma should have an asthma review at least annually if well-controlled and more often if poorly controlled. They should also be reviewed after every asthma exacerbation. This is crucial as an asthma exacerbation is a sign of a failure of the treatment plan, and is a marker for future exacerbations and risk of death. However, primary care will need updated systems and capacity to identify and review exacerbations from all acute settings.

Identifying poor control is important

A key theme within the updated guideline is that a lot of asthma care should happen outside of the annual review – for example, it recommends observing inhaler technique at every opportunity and that patients should always undergo post-exacerbation reviews. Note also the guidance recommends a review of asthma control and medication early in pregnancy and in the postnatal period.

Asthma control should be checked at every review. This means that all clinicians in contact with people with asthma need to be able to effectively perform all of these actions, not just those working in practice asthma clinics.

The check should include:

  • Asthma Control Test, children’s Asthma Control Test or Asthma Control Questionnaire.
  • Time off school or work.
  • Number of courses oral steroids.
  • Number of emergency presentations with chest symptoms.
  • Reliever inhaler use include checking the prescribing record.
  • Peak flow if this is part of someone’s asthma action plan. However, having a measure of someone’s peak flow when well can be a useful benchmark for acute episodes.

For adults with asthma, GPs should also now consider monitoring FeNO levels at their regular review, and before and after changing treatment (see below).

Uncontrolled asthma can include one or both of:

  • any asthma exacerbation needing treatment with oral corticosteroids;
  • frequent regular symptoms such as: needing a reliever inhaler 3 or more days per week, or; having 1 or more nights per week when asthma causes night-time waking.

Assessing inflammation is a key part of the monitoring process

In adults only, FeNO should now be considered within the annual review as well as before and after any change in therapy. A high FeNO level demonstrates untreated eosinophilic inflammation. This might be because of poor adherence to preventer medication, inadequate inhaler technique or a need for a higher dose of inhaled steroids.

If FeNO is not raised in someone who continues to have asthma-like symptoms despite treatment, consider alternative causes for those symptoms rather than simply increasing the inhaler dose.

FeNO and eosinophil levels should also be measured in anyone over 12 who is poorly controlled despite good adherence with a moderate-dose MART inhaler. Raised levels of either should trigger a referral to a specialist asthma service to consider specialist treatments such as biologics.

If neither are raised in anyone over 12 who is poorly controlled despite good adherence with a moderate-dose MART inhaler then a limited trial of montelukast and a LAMA should be tried. Where these fail to control symptoms then a referral to a specialist asthma service is indicated.

Self-management advice

Provide patient education

As well as a personalised written asthma action plan, adults, children and their carers should now be offered:

  • Education about their asthma and how to self-manage their symptoms.
  • Information about common triggers and how to address them including indoor and outdoor pollution.
  • Smoking cessation advice and support.

Schools and health services should work together to provide in-school asthma self-management education programmes provided by appropriately trained personnel. Processes need to be developed to support both schools and the NHS to work closer together to support children with asthma.

Dr Andrew Whittamore is a GPSI in respiratory medicine in Hampshire

References

  1. NICE. Asthma: diagnosis, monitoring and chronic asthma management (BTS, NICE, SIGN). [NG245] 27 November 2024
  2. Levy M, Beasley R, Bostock B et al. A simple and effective evidence-based approach to asthma management: ICS-formoterol reliever therapy. Br J Gen Pr 2024; 74(739):86-89

Resources and further reading

NICE. Asthma: diagnosis, monitoring and chronic asthma management (BTS, NICE, SIGN). [NG245] Resources: Inhaled corticosteroid doses for the BTS, NICE and SIGN asthma guideline. 27 November 2024

Primary Care Respiratory Society UK. Are you ready for the new asthma guideline? 2024

Asthma and Lung UK. Resources for healthcare professionals

Asthma and Lung UK. Resources for patients


          

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READERS' COMMENTS [2]

Please note, only GPs are permitted to add comments to articles

GAUTAM SEHDEV 12 December, 2024 6:40 pm

At my local ICB, we have local guidelines on the management of asthma, but I have the following questions with the new NICE guidance.

When it comes to AIR, I was under the impression that the only inhaler, MDI or DPI, licensed for prn use was Symbicort Turbohaler 200/6. However, on closer inspection of the BC ICB Adults guidelines for 2022, it shows Fostair 100/6 MDI (or DPI NextHaler) & Fobumix 160/4.5 (DPI) can be used as 1 puff when needed.

Now that the new guidelines apply to anyone 12+, can you confirm that the latter two inhalers I mention can be used as AIR as an alternative to the Symbicort Turbohaler 200/6, please?

Also, the new guidelines mentions

“Another addition to the joint guidance following consultation was a recommendation to consider providing an additional metered SABA inhaler plus spacer for emergency use for children under 12 years who may be unable to activate a dry powder inhaler during an acute asthma attack.”

I know DPIs are not recommended in below 12s, but can be used from 10 – 12 years if appropriate?

I’m not sure giving a SABA (as a precaution) alongside AIR/MART therapy is something we should promote?

Caroline Price 4 March, 2025 12:25 pm

Dear Gautam, Dr Whittamore responded to your questions as follows:
RE: When it comes to AIR, I was under the impression that the only inhaler, MDI or DPI, licensed for prn use was Symbicort Turbohaler 200/6. However, on closer inspection of the BC ICB Adults guidelines for 2022, it shows Fostair 100/6 MDI (or DPI NextHaler) & Fobumix 160/4.5 (DPI) can be used as 1 puff when needed.
Now that the new guidelines apply to anyone 12+, can you confirm that the latter two inhalers I mention can be used as AIR as an alternative to the Symbicort Turbohaler 200/6, please?

AW: The guideline has 3 things to help guide you here. Firstly it is explicit in suggesting that odd-license prescribing may be considered. Secondly, base your inhaler choice on the device the patient can use best. Thirdly, there are tables outling what counts as low, moderate and high dose inhalers. So, any ICS-formoterol inhaler at the appropriate dose, whether licensed or not could be used for AIR/MART.

RE: Also, the new guidelines mentions
“Another addition to the joint guidance following consultation was a recommendation to consider providing an additional metered SABA inhaler plus spacer for emergency use for children under 12 years who may be unable to activate a dry powder inhaler during an acute asthma attack.”
I know DPIs are not recommended in below 12s, but can be used from 10 – 12 years if appropriate?
I’m not sure giving a SABA (as a precaution) alongside AIR/MART therapy is something we should promote?

AW: This is a bit of a grey area in asthma prescribing. For adults and children the ability to use a dry powder inhaler effectively may vary between acute and routine settings and should be considered when choosing an inhaler with your patient. Better routine care and the use of AIR/MART will prevent many acute asthma attacks. Studies showed that the vast majority of adults could use a DPI in an acute scenario. It would be counter-intuitive to give AIR/MART and a separate saba mdi+spacer in most cases but you should bear in mind whether the patient, especially a child, could manage a DPI if acutely unwell.