NeLM In-Focus Reviews

New 2008 British Guideline on the Management of Asthma Date Published: Author: Author surname: Author affiliation: Source: Resource links: 15/05/2008 Joanne McEntee Medicines Information Pharmacist Northwest Medicines Information Centre, Liverpool. British Thoracic Society and Scottish Intercollegiate Guidelines Network. May 2008. www.sign.ac.uk/pdf/sign101.pdf

Summary The British Thoracic Society and the Scottish Intercollegiate Guidelines Network have jointly published a new British Guideline on the Management of Asthma. Significant changes have been made to the section on diagnosis and monitoring, and sections on non-pharmacological and pharmacological management have been updated to reflect current evidence. A new topic of ‘difficult asthma’ is included; topics of asthma in pregnancy and occupational asthma are unchanged. Other sections have been re-organised and updated to create a section on organisation and delivery of care, and audit, and another on patient education and selfmanagement. Guidance on the content of personalised written action plans is included.

Background The British Thoracic Society and the Scottish Intercollegiate Guidelines Network have jointly published a new British Guideline on the Management of Asthma.1 This replaces the previous 2003 version which was published as a supplement to Thorax,2 and the subsequent on-line versions of 2004, 2005 and 2007. Changes have been made to five sections on diagnosis and monitoring, nonpharmacological management, pharmacological management, organisation and delivery of care, and audit, and patient education and self-management. A new topic of difficult asthma is included within a section on special situations, which also covers unchanged topics of asthma in pregnancy and occupational asthma. What has changed since the 2007 version?3 Section 2. Diagnosis and Monitoring. Significant changes have been made to this section. In adults and children, asthma should be diagnosed by recognising a characteristic pattern of respiratory symptoms and signs in the absence of an alternative explanation. In adults it is important to obtain objective support for the diagnosis by demonstrating airflow obstruction varying over short periods of time using spirometry. Spirometry is considered the preferred initial test to identify airflow obstruction, rather than peak expiratory flow (PEF). PEF should only be used if spirometry is unavailable, to diagnose occupational asthma and to monitor patients with established asthma. The presence or absence of airflow obstruction is also important for determining differential diagnoses. In children, the use of spirometry or bronchial hyperresponsiveness testing adds little to making a diagnosis. Symptoms and, if applicable, a measure of airflow obstruction, should be used to determine a probability of asthma. Co-existent clinical features that influence this probability are listed for adults and children. Patients with a high probability should be offered a trial of treatment; those with a low probability require further investigation of more likely alternative diagnoses or specialist referral. For patients with an intermediate probability of asthma, management may include an explicit trial of treatment for a pre-specified time, watchful waiting (in children) or further investigations, such as reversibility tests or assessment of airway responsiveness. These investigations are described in detail. In-Focus- 2008 British Asthma Guideline 15 May 2008

Recommendations are made for monitoring patients with asthma in primary care. Validated tools that can be used to assess symptoms and other aspects of asthma are summarised. Patients should be reviewed at least annually. Section 3. Non-pharmacological management. More data are available to allow recommendations to be made about a number of nonpharmacological interventions. Recommended interventions Secondary prophylaxis - subcutaneous immunotherapy for patients with asthma who cannot avoid a clinically significant allergen (section 3.3.3). - Buteyko breathing technique to control symptoms (section 3.5.3). Interventions not recommended Primary prophylaxis (for preventing childhood asthma) - aeroallergen avoidance (section 3.1.1). - maternal food allergen avoidance during pregnancy and lactation (section 3.1.2). - modified infant milk formulae (section 3.1.4). - fish-oil supplementation in pregnancy (section 3.1.6). Secondary prophylaxis - sublingual immunotherapy (section 3.3.3). - probiotics (section 3.4.5). - air ionisers (section 3.5.2). Evidence for the usefulness of other interventions in preventing or treating asthma is described. More research is required on the use of dietary probiotics in pregnancy to reduce the incidence of childhood asthma (section 3.1.8), on vitamin C supplementation in children with asthma (section 3.1.9), on avoidance of indoor aeroallergens (section 3.2.2), on sublingual immunotherapy for treatment of asthma (section 3.3.3), on complementary and alternative medicine (section 3.5), on herbal and traditional Chinese medicine (section 3.5.4) and to establish whether immunotherapy may have a role in primary prophylaxis (section 3.1.10). The following sections are new or have been expanded: Section 3.1.5 Weaning Evidence on modified weaning is conflicting and insufficient to inform recommendations. Section 3.1.7 Other nutrients Observational studies have suggested that reduced maternal intake of selenium and vitamin E may be associated with an increased risk of subsequent childhood asthma. No intervention studies have been conducted and the evidence is insufficient to make recommendations. Section 3.1.11 and 3.4.6 Immunisation Some studies suggest BCG and other childhood immunisations may have a protective effect against allergic disease and asthma. Recommendations are to proceed with childhood immunisations according to national vaccination schedules as there is no evidence of an adverse effect on the incidence of asthma. Influenza vaccine does not exacerbate asthma in children. Research is needed to determine the effects of high dose inhaled corticosteroids on vaccine response. Section 3.4.1 Electrolytes Sodium and magnesium intake may be important in the prevalence of asthma. A systematic review concluded dietary salt restriction could not be recommended in the management of asthma. More trials of oral supplementation with magnesium are needed. In-Focus- 2008 British Asthma Guideline 15 May 2008

Section 3.4.3 Anti-oxidants A high intake of fresh fruit and vegetables is associated with less asthma in observational studies involving adults and children. No intervention studies have yet been reported. Section 3.5.6 Hypnosis and relaxation therapies Muscle relaxation may benefit lung function in patients with asthma. Section 4. Pharmacological management. Significant changes to this section of the guideline were published on-line in July 2007 and the new 2008 version includes only a small number of additional revisions. All major changes made in 2007 and 2008 are summarised below: The aim of asthma management is control of the disease (newly defined as no daytime symptoms, no night time awakening due to asthma, no need for rescue medication, no exacerbations, no limitations on activity and normal lung function) with minimal side effects. Section 4.2.1 Inhaled steroids Many children with recurrent episodes of viral-induced wheezing in infancy do not develop chronic atopic asthma and do not require regular inhaled steroids. Section 4.2.2 Safety of inhaled steroids (in children) Clinical adrenal insufficiency has been identified in a small number of children who became acutely unwell at the time of intercurrent illness. Most had been treated with high doses of inhaled corticosteroid. The dose or duration of inhaled corticosteroid that places a child at risk of clinical adrenal insufficiency is unknown. When treating children with 800microgram or more per day of beclometasone dipropionate or equivalent (rather than 1,000microgram as in the previous version of the guideline) the guideline advises that:
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Specific written advice about steroid replacement in the event of a severe intercurrent illness should be part of the management plan. The child should be under the care of a specialist paediatrician for the duration of the treatment.

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Section 4.2.3 Comparison of inhaled steroids Evidence suggests ciclesonide may cause fewer systemic and local oral adverse effects than other inhaled corticosteroids. However, no specific recommendations on use are made as the efficacy to safety ratio compared to other inhaled corticosteroids has not been established. The guideline highlights that non-CFC beclometasone is available in more than one preparation, and their potency relative to CFC-containing beclometasone is not consistent. NICE guidance on inhaled corticosteroids for the treatment of chronic asthma in adults and in children aged 12 years and older,4 and for the treatment of children under the age of 12 years,5 recommends using the least costly licensed product that is suitable for the individual. Section 4.2.4 Smoking Patients who are smokers or ex-smokers may need higher doses of inhaled corticosteroids. Section 4.3.2 Add-on therapy Long-acting inhaled beta-2 agonists should only be started in patients who are already on inhaled corticosteroids.

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Section 4.3.3 Combination inhalers Combination inhalers containing a steroid and long-acting beta-2 agonist are useful in ensuring that beta-2 agonists are not used without concomitant inhaled steroid. Use of a budesonide/formoterol combination inhaler as rescue medication (in addition to regular use), instead of a short acting beta-2 agonist, is effective but requires careful patient education. No further guidance on the place of this product in therapy is provided. This management technique has not been investigated with other combination inhalers. NICE recommends that if treatment with an inhaled corticosteroid and long-acting beta-2 agonist is needed, the decision over whether to use a combination device or separate inhalers should be made on an individual basis taking into account likely treatment adherence, therapeutic need and cost of the product(s).4,5 Use of the combination inhaler budesonide/formoterol (Symbicort®) in a treatment regimen to provide both maintenance and reliever therapy (Symbicort SMART®) was accepted for use within NHS Scotland in March 2007.6 Section 4.5 Continuous or frequent use of oral steroids Daily steroid tablets in the lowest dose to provide adequate control are recommended for patients not controlled at step 4. Section 4.5.2 Steroid tablet-sparing medication Data are insufficient to recommend use of anti-TNF alpha therapy except as part of a controlled clinical trial. Section 4.7.6 Gastro-oesophageal reflux A Cochrane review has concluded that treatment of gastro-oesophageal reflux has no beneficial effect on asthma symptoms or lung function. Section 4.7.8 Anti IgE monoclonal antibody Evidence for omalizumab in the treatment of asthma is summarised. Due to a risk of anaphylaxis, administration should occur under direct medical supervision. Omalizumab should only be initiated in specialist centres with experience of evaluation and management of patients with severe and difficult asthma. NICE issued guidance on the use of omalizumab for severe persistent allergic asthma in November 2007.7 Omalizumab is recommended, within its licensed indication, as add-on therapy to optimised standard therapy, in adults and children 12 years and older who fulfill specific criteria for severe unstable allergic disease. Standard therapy is defined as a full trial of, and documented compliance with, inhaled high-dose corticosteroids and long-acting beta-2 agonists in addition to leukotriene receptor antagonists, theophyllines, oral corticosteroids and oral beta-2 agonists, as well as smoking cessation where appropriate.

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Section 7.1 Difficult asthma and Section 7.2 Factors contributing to difficult asthma. In these new sections ‘difficult asthma’ is defined as persistent symptoms and/or frequent exacerbations despite treatment at step 4 or step 5. Assessment of patients considered to have difficult asthma should be facilitated through a multidisciplinary difficult-asthma service provided by a team experienced in the assessment and management of difficult disease. Patients should be systematically evaluated, compliance with therapy assessed and the mechanism of persistent symptoms identified. Possible factors contributing to difficult asthma are described in detail.

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Section 8. Organisation and delivery of care, and audit. This section includes a significant number of changes. It contains information from two previously separate sections – organisation and delivery of care, and also outcomes and audit. It describes the key features of effective asthma services in primary and secondary care together with appropriate audit measures. It is recommended that patients should receive written action plans as these have been shown to improve outcomes. Patients who attend emergency departments or require admission for an acute exacerbation of asthma should receive self management planning as soon as clinical improvement is seen and before discharge. An appointment made, prior to discharge, for a review in primary care within 30 days following discharge, improves follow-up rates. Section 8.3.2 lists all recommended audits within the guideline.

Section 9. Patient education and self management. This section provides new information on the suggested content of action plans, which need to be written, personalised and supplemented with patient education. The key components that have been shown to improve outcomes include using symptoms and regularly updated personal best PEF levels as triggers, limiting the number of action points to two or three and supplying inhaled and oral steroids for emergency use. This section also includes information on concordance and compliance, which was presented separately in the previous version of the guideline. Minor changes have been made. Compliance with treatment can be assessed using computer repeat-prescribing systems. Computer, innovative web-based and nurse-led telephone-based self management programmes can increase the use of regular medication.

References

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British Thoracic Society and Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma. Thorax 2008; 63 (Suppl 4): iv1-iv121. Also available via www.britthoracic.org.uk/Portals/0/Clinical%20Information/Asthma/Guidelines/asthma_final2008.pdf and www.sign.ac.uk/pdf/sign101.pdf. 2 British Thoracic Society and Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma. Thorax 2003; 58 (Suppl 1): i1-i94. 3 British Thoracic Society and Scottish Intercollegiate Guidelines Network. British Guideline on the Management of Asthma. Revised edition July 2007. Accessed via www.britthoracic.org.uk/Portals/0/Clinical%20Information/Asthma/Guidelines/asthma_fullguideline2007.pdf on 12/052008. 4 National Institute for Health and Clinical Excellence. NICE Technology Appraisal guidance 138. Guidance on inhaled corticosteroids for the treatment of chronic asthma in adults and in children aged 12 years and over. March 2008. Accessed via www.nice.org.uk/nicemedia/pdf/TA138guidance.pdf on 12/05/2008. 5 National Institute for Health and Clinical Excellence. NICE Technology Appraisal guidance 131. Guidance on inhaled corticosteroids for the treatment of chronic asthma in children under the age of 12 years. November 2007. Accessed via www.nice.org.uk/nicemedia/pdf/TA131guidance.pdf on 12/05/2008. 6 Scottish Medicines Consortium. Budesonide/formoterol 100/6, 200/6 turbohaler (Symbicort SMART®) for asthma - full submission. 9 March 2007 (issued May 2007). Accessed via www.scottishmedicines.org.uk/smc/files/budesonideformoterolturbohaler_SymbicortSMART_36207.pdf on 12/05/2008. 7 National Institute for Health and Clinical Excellence. NICE Technology Appraisal guidance 133. Guidance on omalizumab for severe persistent allergic asthma. November 2007. Accessed via www.nice.org.uk/nicemedia/pdf/TA133Guidance.pdf on 12/05/2008.