When MART isn’t the answer – options in asthma management

AIR and MART are now well established as the preferred options for the management of asthma, but there are always exceptions to the rule: what should GPNs do when these approaches are unsuitable for the individual with asthma?

It has been a year since the updated national guidelines for the management of asthma were published by the British Thoracic Society (BTS), the Scottish Intercollegiate Guidelines Network (SIGN) and the National Institute for Health and Care Excellence (NICE).¹ Reflecting the approach taken by the Global Initiative for Asthma (GINA), the focus moved towards the use of combination inhalers which contain an inhaled corticosteroid (ICS) plus formoterol, a fast- and long-acting beta2 agonist (LABA), and away from using separate inhalers for the prevention and relief of symptoms.² These ICS/formoterol combination inhalers can be used as anti-inflammatory reliever (AIR) therapy or as maintenance and reliever therapy (MART).However, although this is the preferred approach to managing asthma, there are always exceptions to the rule.In this article, we identify some of those exceptions, give examples of when and why AIR or MART may not be appropriate, and suggest alternative strategies which may be more suitable.

ASTHMA MANAGEMENT IN ADULTS

The AIR approach to asthma management is based on prescribing one inhaler which contains a combination of ICS and formoterol, and which is used solely in response to asthma symptoms. The AIR approach means that symptom relief occurs within 1-3 minutes of taking the inhaler but that the anti-inflammatory action of the ICS addresses the cause of those symptoms, reducing the risk of a more significant exacerbation.^3,4 MART takes the same approach to using the ICS/formoterol inhaler for symptom relief but includes a ‘maintenance’ element, meaning that people take a daily dose of their inhaler along with additional reliever doses as needed. This approach has been shown to improve symptom control and reduce the risk of future exacerbations.⁵ The decision about whether AIR or MART is more appropriate for the individual should be made through discussion with the individual and assessment of their needs.There is also the option to move between regimes, i.e., starting with AIR and moving to MART or vice versa.This offers people a built-in self-management plan whereby they use more of their inhaled therapy when they need it and less when they don’t, basing their use on factors such as triggers, airborne allergens, weather and air quality.AIR and MART ensure that the person living with asthma (PLwA) treats the underlying inflammation that drives any symptoms every time they use their inhaler.There is a range of devices licensed to use as AIR or MART, meaning that for most people, either of these approaches will be suitable.As long as people understand how to move between these regimes, how to recognise poor control and when to seek medical help, AIR and MART will be appropriate for the majority of PLwA.However, there are exceptions to this generalisation, and these should be noted.

ASTHMA MANAGEMENT IN CHILDREN

When they were launched, both AIR and MART approaches were licensed in people aged 12 and over.Recently, however, the MART licence for Symbicort has been extended to children from age 6. It should be noted that the licence for Symbicort MART in children aged 6-11 is for the 100/6mcg Turbohaler, taken as 1 dose daily, plus extras as needed, up to a maximum of 6 doses in a day with no more than 4 doses taken in one go.In certain circumstances, 8 doses in total may be taken – see https://www.medicines.org.uk/emc/product/1326/smpc.

Below the age of 6, and in any child where MART is not considered suitable, the recommended treatment for asthma continues to be an ICS for daily use and a separate short-acting beta2 agonist (SABA) for symptom relief.¹ The usual recommended dose of ICS in children is 200mcg as a total daily dose (e.g., Clenil 50mcg 2 puffs twice daily).However, there are other ICS inhalers containing different molecules that may be used, and which will need a dose adjustment e.g., fluticasone propionate is more potent than other ICS, so is given at half of the standard dose of ICS, e.g., Flixotide 50mcg 1 puff twice daily.

If an ICS does not achieve complete control of the asthma and the child requires regular SABA relief (more than 2-3 doses per week), the next step should be to add in a leukotriene receptor antagonist (LTRA) or a LABA. The BTS/SIGN/NICE guidelines endorse the use of an LTRA, and montelukast is licensed from 6 months of age, but clinicians should be mindful of the Medicines and Healthcare products Regulatory Agency (MHRA) advice about the potential neuropsychiatric side effects of this medication and should ensure that patients and parents are also aware of this warning, and factor it into their decisions.6 LTRAs are discussed in more detail below.

If the addition of a LABA is preferred, there are several ICS/LABA combinations that can be prescribed across different age groups.Along with Symbicort, combination therapies which are licensed for use in children under the age of 12 include Seretide (containing fluticasone propionate and salmeterol) in the Accuhaler and pMDI devices, which are both licensed to use from the age of 4.These inhalers must be used in a fixed dose regime, i.e., twice daily with a SABA reliever if needed. This is because the slow onset of action of salmeterol means that it will not give fast symptom relief – which is also why it is not suitable or licensed for AIR or MART. Another LABA with a slower onset of action is vilanterol, found in Relvar, which is licensed from age 12. There is also Flutiform (containing fluticasone propionate and formoterol) in a pMDI, which is licensed for use from the age of 5. Although Flutiform contains formoterol, is does not have a licence for AIR or MART at any age.The BTS/SIGN/NICE guidelines take the view that products may be used off label if the prescriber considers this to be appropriate for the PLwA, but there are medicolegal considerations to bear in mind with off-label prescribing.These include recommendations from the MHRA that a licensed product should be used if available.If off-label prescribing is still deemed to be appropriate, it should be documented in the notes that the rationale for off-label prescribing has been explained to the patient (or parent) and that they have agreed to the use of an off-label product.⁷

DEVICE CHOICE

As well as considering the inhaler ingredients, it is important to ensure that the inhaler device can be used by the PLwA.For some people, device preference may dictate the choice of drug treatment. For example, if someone prefers the Accuhaler device then Seretide will be the drug of choice; if they like the Ellipta device and the option to use their inhaler just once daily, then Relvar would be the most appropriate treatment. However, a SABA should always be prescribed with any inhaler which contains any non-formoterol LABA. In the case of children, it is generally recommended that a pMDI and spacer is prescribed, although there is some evidence to say that some children may be able to use dry powder inhalers.⁸As mentioned above, the Turbohaler is licensed to use from the age of 6 and the Accuhaler from age 4, but it is not necessarily the case that children of this age would be able to use a DPI. In general, DPIs may be easier to use and are more environmentally friendly (although see below for news about the next-generation propellants), and most adults and many older children can use a DPI effectively. As always, decisions regarding inhaler devices should be made on a case-by-case basis using a shared decision-making approach, taking into account patient preference and their ability to use the device. The most environmentally friendly device is the one the PLwA can and does use.

ADDITIONAL APPROACHES TO INHALED THERAPIES FOR ASTHMA

The asthma review offers an opportunity to assess asthma control, use of medication and possible indications for changing the person over to AIR or MART if they are not already using these approaches.However, the BTS/SIGN/NICE guidelines are clear that there is no obligation to swap people over if they are happy with their current treatment and are, importantly, well controlled.Nonetheless, explanations as to why AIR and MART are the preferred treatment options i.e., that these regimes are associated with a lower risk of exacerbations and hospitalisations, should be given so that people can make an informed decision about how they would like to proceed.

For people who are anxious about ‘losing’ their SABA, they can be reassured that the reliever is already in their new inhaler and that this is an ‘upgrade’ as the LABA will last for longer than the SABA.They should also be reassured that the onset of action for formoterol is on a par with their SABA, at around 1-3 minutes.⁴

SABA-ONLY TREATMENT

If people are currently using a SABA as monotherapy for their asthma and are not using any preventer inhalers, the situation is different.From a medicolegal perspective, clinicians should realise that providing a SABA, without a preventer inhaler, is associated with an increased risk of harm, and could therefore be deemed to be clinically negligent. It could also be seen as a breach of the professional standards set by the Nursing and Midwifery Council, which specifically state that nurses should practise effectively, preserve safety and promote professionalism and trust.⁹ In rare circumstances, this would have to be weighed up against the potential harm of not providing the medication. Unfortunately, there are several ways in which PLwA can access medication such as SABAs from non-NHS sources, leaving them at risk of harm while their NHS clinicians remain oblivious to the possibility of such harm. An information-gathering exercise has been launched by the Department of Health and Social Care to consider how NHS staff should be involved in the care of people accessing medication from non-NHS sources, and it will be interesting to see the results of this consultation.¹⁰ The key issue here is that patients and healthcare professionals need to communicate effectively and work together to ensure optimal health outcomes. PLwA should understand that clinicians are not putting up barriers to them getting their inhalers but are acting in an evidence-based way in line with their professional code of conduct to optimise patient safety and wellbeing.

LEUKOTRIENE RECEPTOR ANTAGONISTS (LTRAs)

As mentioned above, LTRAs are endorsed by the BTS/SIGN/NICE guidelines for the management of asthma, when used alongside an ICS-based therapy.1 As their name suggests, LTRAs work by blocking the action of leukotrienes, which are part of the inflammatory process in asthma. In people with a very active leukotriene pathway, the use of an LTRA can have a significant effect on asthma symptoms.This is achieved through reducing inflammation, bronchoconstriction and mucus production.¹¹ BTS/SIGN/NICE recommends trialling these for 2–3 months, although their impact is often felt much sooner.¹ LTRAs can be used with an ICS, or an ICS/LABA and also with triple therapy.The risk: benefit ratio of the medication should always be taken into account, in accordance with the MHRA advice explained above, and consideration should be given to referring people to secondary care who need multiple therapies to achieve asthma control.

TRIPLE THERAPY FOR ASTHMA

Triple therapy usually refers to the use of an ICS/LABA with the addition of a long-acting muscarinic antagonist (LAMA).In asthma, a LAMA can help to improve lung function and symptoms by relaxing the smooth muscles in the airways, and can be taken as a separate inhaler in addition to a MART regime, or in a single inhaler which contains all three ingredients.

At the time of writing, there is only one triple therapy inhaler licensed to use in asthma, which is Trimbow, in a pMDI. Trimbow contains extra-fine particle beclometasone, with the LABA formoterol and the LAMA glycopyrronium. It is licensed as a maintenance treatment of asthma, in adults not adequately controlled on a medium dose ICS/LABA and who have experienced one or more asthma exacerbation(s) in the previous year. Trimbow should be taken at a fixed dose of 2 puffs twice daily. It is not licensed to use as AIR or MART, so a separate SABA should be prescribed for symptom relief. If it is decided that the MART approach should be maintained, Spiriva in the Respimat device is the only LAMA licensed for asthma. This can be prescribed from the age of 6 upwards, and the dose is fixed at 2 puffs daily. Studies on the impact of triple therapy in a single inhaler for uncontrolled asthma have demonstrated that the addition of a LAMA to an ICS plus a LABA improves lung function and reduces exacerbations.¹² Furthermore, an interim analysis of a recent real-world study, TriMaximize, on the use of single inhaler triple therapy (SITT) in uncontrolled asthma, showed that after 6 months on Trimbow, 48.5% of patients had improved Asthma Control Test scores (20-25) versus 18.1% at baseline, use of rescue medication dropped by 5 puffs a week and there was a 94% decrease in mean exacerbation rates after 6 months.¹³

Local guidance should be consulted as to whether a referral should be made for anyone requiring triple therapy for asthma, although there is no reason why PLwA should not be able to try triple therapy before, or while awaiting a referral.

COPD-A

COPD-A is the most recent term used by the GOLD guidelines committee to describe COPD with an underlying asthma component, and which is more commonly referred to as asthma/COPD overlap.¹⁴ People with COPD-A have asthma with fixed airways, often related to airway remodelling, so will need an ICS to address the asthma component of their condition, along with bronchodilator therapy to address their symptoms and reduce the risk of exacerbations. NICE guidelines for COPD recommend the use of dual bronchodilators for COPD and so people with COPD-A are most likely to benefit from a triple therapy.¹⁵ There are three SITTs licensed for COPD: Trimbow in the pMDI and the NextHaler, Trelegy in the Ellipta device and Trixeo in the Aerosphere pMDI.The latter is currently being relaunched with a next-generation propellant (NGP) which makes the pMDI as environmentally friendly as a DPI.Trixeo is currently the only inhaler using this NGP and the launch in the UK was a world-first. Other pMDIs with NGPs will follow in due course. Trixeo recently demonstrated positive outcomes in the treatment of asthma in the recent KALOS and LOGOS trials but is not currently licenced for treating asthma.^16,17

BIOLOGICS FOR ASTHMA

Primary care clinicians should spend no longer than 6 months trying to achieve control of asthma symptoms.Starting with AIR and MART, consideration should be given to the addition of an LTRA and/or a LAMA in people who remain uncontrolled, after assessing for adherence and inhaler technique and following treatment for any comorbidities which may be mimicking asthma or affecting asthma control. These might include gastro-oesophageal reflux, inducible laryngeal obstruction or allergic rhinitis.¹⁸ The HASTE tool was developed by Health Innovation Oxford as an aide memoire for referring people with poor control into secondary care for consideration of a biologic.¹⁹ The team in secondary care will carry out a further assessment before referring onto the Severe Asthma Centre (SAC) where indicated. The SAC will determine whether a biologic should be tried and which biologic might be most appropriate. They will continue to work with the PLwA to optimise management before referring them back to primary care. Practices should have a register of their severe asthma patients and should continue to review and support them with their asthma management. The Primary Care Respiratory Society Desktop Helper on biologics is a useful source of information on these therapies and can be accessed here https://www.pcrs-uk.org/sites/default/files/resource/WP_PCRS_Asthma-Biologics_V05.pdf.

SUMMARY

For the majority of PLwA, an ICS/formoterol inhaler used as AIR or MART will provide a route to asthma management which has a built-in tailored and personalised element which is likely to optimise asthma control.AIR can be used from age 12, with one MART option now being licensed from age 6.However, younger children may need a different approach, taking into consideration their age, with respect to choice of medications prescribed, and their dexterity and co-ordination when using the delivery device.In PLwA aged 6 and over who are already using an ICS plus SABA or another combination inhaler, the offer of moving to an ICS/formoterol inhaler should be considered, along with an explanation as to why this change would be recommended, based on national and international guidance. In people who have poorly controlled asthma despite using MART, the addition of an LTRA or a LAMA should be considered. No treatment should be initiated or altered without a review of triggers, adherence and inhaler technique.Confounding factors such as allergic rhinitis and reflux should be identified and treated. The indications for referral into secondary care should be noted in order to assess for the possibility of severe asthma which might respond to a biologic.

RESOURCES

• Association of Respiratory Nurses https://arns.co.uk/
• Primary Care Respiratory Society https://www.pcrs-uk.org/
• Asthma and Lung UK https://www.asthmaandlung.org.uk/
• Rightbreathe https://www.rightbreathe.com/
• MART initiation for beginners. Practice Nurse 2025;55(5):22-25

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