ICS consensus

Information intended for healthcare professionals only.

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Consensus group members

  • Dr Omar Usmani (Chair)—Reader in Respiratory Medicine & Consultant Physician, Imperial College London & Royal Brompton Hospital
  • Dr Toby Capstick—Consultant Pharmacist, Respiratory Medicine, Leeds Teaching Hospitals NHS Trust
  • Dr Kevin Gruffydd-Jones—FRCGP, Box, Wiltshire
  • Dr Honor Merriman—GP, NHS Oxfordshire; NHS England Thames Valley GP Appraisal Lead
  • Jane Scullion—Respiratory Nurse Consultant, University Hospitals of Leicester NHS Trust

 

Introduction

Asthma is a common chronic inflammatory disease of the lungs, which imposes a significant burden on healthcare in the UK.1 Every 10 seconds, someone in the UK has a potentially life-threatening asthma attack and more than 1200 of these people die every year.2 One in 11 people in the UK have asthma and many of them fail to receive the correct asthma medication required to safely manage their condition.2

Management of asthma in adults: current guidance

In the UK, guidance on managing patients with asthma has been published by NICE and also the British Thoracic Society (BTS)/Scottish Intercollegiate Guidelines Network (SIGN).1,3 The cornerstone of asthma management is regular daily maintenance therapy with inhaled corticosteroids (ICS) plus as-needed reliever therapy with short-acting beta2 -agonists (SABAs), although NICE allows the use of as-needed SABA alone for patients with mild intermittent symptoms. Both sets of guidelines advocate an incremental increase or addition of maintenance therapy in order to achieve complete control of asthma (Box 1).1,3

Box 1: Complete control of asthma1

  • No daytime symptoms
  • No night-time awakening due to asthma
  • No need for rescue medication
  • No asthma attacks
  • No limitations on activity, including exercise
  • Normal lung function (in practical terms FEV1 and/or PEF >80% predicted or best)
  • Minimal side effects from medication.

FEV1=forced expiratory volume in 1 second; PEF=peak expiratory flow.

The BTS/SIGN guideline discusses the safety of ICS, stating that there is little evidence that low doses cause any short-term detrimental effects apart from the local side-effects of dysphonia and oral candidiasis (thrush); however, the possibility of long-term effects on bone has been raised.1 Both NICE and BTS/SIGN recommend prescribing add-on therapies before increasing the dose of ICS. They also recommend titrating the dose of ICS to the lowest dose at which effective control is maintained; that is, the treatment of asthma should be a dynamic approach.1,3

The National Review of Asthma Deaths (NRAD) investigated the deaths of 195 people who died from asthma between 2012 and 2013 and found alarming safety concerns in the care they received. In terms of treatment, they observed an underuse of ICS and an overuse of SABAs.

Although the stepwise treatment approach for asthma is relatively straightforward, the myriad inhalers on offer, with different drugs, differences in the way doses are expressed (metered dose and delivered dose), and different particle sizes (fine and extra-fine), mean that choosing and switching inhalers is not a simple task. Furthermore, although asthma is a lifelong disease, patients’ symptoms may improve and worsen over the course of their lives and during the year. Treatment should therefore be tailored to each patient’s individual asthma severity and triggers, increasing when asthma control is poor and decreasing when asthma is well controlled. Identifying treatable traits (observable components that can be modified to improve wellbeing) may enable early and appropriate management of asthma. These include:5

  • pulmonary traits
    • symptoms (wheeze, cough, and breathlessness)
    • modifiable exposures (for example allergens and infections)
    • functional (for example, variable airflow limitation) 
    • biological (for example, elevated fractional exhaled nitric oxide [FeNO])
  • extrapulmonary traits (for example, obesity, rhinosinusitis)
  • behavioural/psychosocial traits.

The latest Global Initiative for Asthma (GINA) guidelines advocate a move towards treating modifiable risk factors, for example, occupation, smoking, and allergens.6

A multidisciplinary group was convened by Guidelines in Practice from across the UK to create a consensus statement with clear, pragmatic, and straightforward guidance focusing on the use of ICS in adults with asthma. This statement is not intended to provide guidance on choice of specific ICS but rather when they should be used, factors to consider when selecting ICS, and when to step up and step down.

Consensus statement: using ICS in adults with asthma

Consensus statement (CS) 1: All patients with asthma should be started and maintained on ICS

  • ICS should be initiated as early as possible in patients with symptoms at presentation that clearly indicate the need for maintenance therapy—for example, symptoms three times a week or more, or causing waking at night
  • According to UK guidance patients should be started on low dose ICS1,3 (400 mcg of budesonide or beclometasone dipropionate [BDP], or equivalent) for 4 weeks as a diagnostic trial; if this confirms diagnosis, patients should be encouraged to continue low-dose ICS in addition to SABA
    • patients with symptoms that are triggered by factors, such as cold weather or allergens may only need to take ICS when symptomatic, but it is best to maintain all patients with a diagnosis of asthma on ICS as a preventative measure
  • The dose of ICS should be the lowest required to be effective with minimal side effects
    • doses <400–800 mcg are not usually problematic in terms of side-effects;7 low dose ICS should be the target for ICS monotherapy (400 mcg BDP or equivalent)
    • patients taking high-dose ICS (≥1000 mcg BDP or equivalent) should be provided with a warning card 
  • Any patient with symptomatic asthma should be maintained on ICS
    • for example, a patient with asthma later diagnosed with chronic obstructive pulmonary disease (COPD) due to development of fixed airway obstruction should still be treated with ICS.

Key recommendations—CS1: All patients with asthma should be started and maintained on ICS

  • ICS should be initiated as early as possible in patients with symptoms at presentation that clearly indicate the need for maintenance therapy
  • If a diagnostic trial of low-dose ICS confirms the diagnosis, patients should be encouraged to continue low-dose ICS in addition to SABA
  • The dose of ICS should be the lowest required to be effective with minimal side effects
  • Any patient with symptomatic asthma should be maintained on ICS.

CS2: ICS are not interchangeable due to the different available formulations, particle sizes, and delivery methods

  • ICS are not interchangeable due to the different available formulations, particle sizes, and delivery methods
    • different devices (pressurised metered-dose inhaler [pMDI] or dry powder inhaler [DPI]) deliver drugs in different formats and doses, and require different inhalation techniques
    • different DPIs have different resistances 
    • resistance may change when moving from monotherapy to a combination inhaler 
    • asthma drugs should be prescribed by brand1 to ensure that patients always receive a consistent device and dose
  • Choice of drug should take into account efficacy, safety, available inhaler device, cost, patient preference following an informed discussion, and local guidelines
  • When prescribing inhaler devices, optimise technique and adherence by considering the patient’s best-fit inhaler and patient preference8
    • if the patient can only perform a quick and deep manoeuvre (quick, deep breath in within 2–3 seconds), consider a DPI
    • if the patient can only perform a slow and steady manoeuvre (slow, steady breath in over 4–5 seconds), consider a pMDI
    • if the patient can perform both inhalation manoeuvres, consider a DPI or pMDI
    • ensuring patients are comfortable with their device may improve adherence to treatment1
  • Spacers are not necessary for all patients using ICS but may be useful for small children, the elderly, patients with poor coordination, and patients prone to local oropharyngeal side-effects such as oral candidiasis
    • a pMDI with or without a spacer is as effective as any DPI in adults1
    • spacers may be used with MDIs to reduce side-effects such as oral candidiasis; gargling after ICS can also reduce the risk of developing oral candidiasis6
  • When using an inhaler, lifting the chin pushes the tongue back, opens the throat, and widens the airway into the lung; not lifting the chin is a common error9
  • Use of drugs with extra-fine particles improves asthma control and reduces the required dose of ICS10
    • extra-fine particles are <2.1 µm10,11
    • a large proportion of large-particle drugs only reach the large airways and not the alveoli; extra-fine particles push deeper into the lungs, acting at sites of active inflammation10,12
  • A systematic review with more than 30,000 patients found that use of extra-fine BDP or ciclesonide significantly improved asthma control and reduced exacerbations at lower prescribed doses of ICS compared with use of fine-particle ICS.10

Key recommendations—CS2: ICS are not interchangeable due to the different available formulations, particle sizes, and delivery methods

  • Different ICS have different formulations, particle sizes, delivery methods, and devices (pMDI and DPI)
  • Asthma drugs should be prescribed by brand to ensure that patients always receive a consistent device and dose
  • Choice of drug should take into account efficacy, safety, available inhaler device, cost, patient preference following an informed discussion, and local guidelines
  • When prescribing inhaler devices, optimise technique and adherence by considering the patient’s best-fit inhaler and patient preference8
  • Spacers are not necessary for all patients using ICS but may be useful for small children, the elderly, patients with poor coordination, and patients prone to local oropharyngeal side-effects such as oral candidiasis
  • Use of drugs with extra-fine particles improves asthma control and reduces the required dose of ICS.10

CS3: Management of asthma should be dynamic, stepping ICS up and down as appropriate

  • Asthma is a lifelong disease, but symptoms can vary seasonally and through a patient’s life
  • Management of asthma should be dynamic, with maintenance therapy increased when asthma is poorly controlled and reduced when control is achieved
  • The key premise of treatment for asthma is symptom control to reduce impact on daily life, but it is also important to consider future risk of asthma attacks in treatment decisions (Table 1)

ICS consensus_table 1

  • Poor adherence to ICS and overuse of SABA provides a good indicator of asthma control and future risk (Figure 1)
    • good control is using SABA no more than twice per week (on average no more than two canisters a year)
    • two or more SABA canisters during 12 months in adults best predicts an increased risk of asthma-related exacerbation, with each additional canister increasing the risk by 14–18%13
    • for ICS aim to achieve >80% adherence,14 on average this is ten ICS/long-acting beta2 -agonist (LABA) or six ICS MDI canisters per year
    • each additional canister of ICS per year is associated with a 21% decrease in the rate of death from asthma15
    • asking how many canisters of ICS and SABA patients are using or checking repeat prescription history (focusing on the past 12 months) can be a useful guide to asthma control and future risk
      • taking into account replacements for lost inhalers and ‘spare’ inhalers, no more than three reliever canisters may be more realistic in practice than two
    • audit can identify patients using too many reliever or too few preventer inhalers, whose management should be reviewed 

ICS consensus_Figure 1

  • Patients should be reviewed regularly so that symptom control, medication adherence, and inhaler technique can be checked, and a personalised management plan put in place, in line with NRAD recommendations4
  • Follow up should be at least annually, but more frequently for patients with overuse of SABAs or underuse of ICS
  • Patients who do not attend annual reviews should be contacted to arrange an appointment.

Key recommendations—CS3: Management of asthma should be dynamic, stepping ICS up and down as appropriate

  • Management of asthma should be dynamic, with maintenance therapy increased when asthma is poorly controlled and reduced when control is achieved
  • The key premise of treatment for asthma is symptom control to reduce impact on daily life, but it is also important to consider future risk of asthma attacks in treatment decisions
  • Poor adherence to ICS and overuse of SABA provides a good indicator of asthma control and future risk
  • Patients should be reviewed regularly so that symptom control, medication adherence, and inhaler technique can be checked, and a personalised management plan put in place.

CS4: Step up therapy when asthma is poorly controlled and the patient is at risk of exacerbations

  • Therapy should be stepped up when asthma is poorly controlled and the patient is at risk of exacerbations (Table 2)
  • Control should be assessed according to the GINA or BTS/SIGN guidelines,1,6 including symptoms, lung function, SABA use, and other factors that indicate poor control or increased future risk (Table 2)

ICS consensus_table 2

  • Before stepping up, check the basics:
    • diagnosis 
    • inhaler technique 
    • modifiable exposures such as environmental factors, new pets, or hayfever
    • adherence 
  • Introduce add-on therapy before stepping up the ICS dose
  • Step up therapy according to current guidance1,3
  • Maintenance and reliever therapy (MART) with a single ICS-formoterol inhaler can be considered for patients uncontrolled on medium dose ICS with or without an add-on therapy.1

Key recommendations—CS4: Step up therapy when asthma is poorly controlled and the patient is at risk of exacerbations

  • Before stepping up, check the basics, including diagnosis, inhaler technique, modifiable exposures, and adherence
  • Control should be assessed according to the GINA or BTS/SIGN guidelines1,6
  • Introduce add-on therapy before stepping up the ICS dose
  • Step up therapy according to current guidance.1,3

CS5: Step down therapy once asthma is controlled to achieve the lowest dose with good control

  • It is vital to regularly review the need for high-dose ICS and step down to the lowest dose that provides control, whenever possible
    • once asthma is controlled it is recommended to decrease therapy but this is often not implemented, leaving some patients overtreated1
  • Healthcare professionals are often resistant to initiate stepping down in their patients when their asthma is controlled,16 the opportunity should not be missed and an informed discussion with the patient is required to obtain consent to step down
    • some patients with specific triggers may be reluctant to step down if they have previously done so and experienced an exacerbation as a result 
  • Step down the dose by 50%1 in patients: 
    • on high doses of ICS to a more rational dose 
    • who have had good control for at least 6 months, without symptoms in the previous 4 weeks, without exacerbations in the past year,17 with no near-fatal asthma in the past 2 years, with low FeNO (where available), and who are not at risk of exacerbation.

Key recommendations—CS5: Step down therapy once asthma is controlled to achieve the lowest dose with good control

  • It is vital to regularly review the need for high-dose ICS and step down to the lowest dose that provides control, whenever possible
  • Healthcare professionals are often resistant to initiate stepping down in their patients when their asthma is well controlled,16 the opportunity should not be missed and an informed discussion with the patient is required to obtain consent to step down
  • Step down the dose by 50% in patients on high doses of ICS, who have had good control for at least 6 months, without symptoms in the previous 4 weeks, without exacerbations in the past year,17 with no near-fatal asthma in the past 2 years, with low FeNO (where available), and who are not at risk of exacerbation.

Conflicts of interest

The group members have received an honorarium to develop this best-practice guidance. Some of the group members have also received consultancy fees from other pharmaceutical companies, which may include CIPLA EU Ltd, for activities other than the development of this best-practice guidance.

Acknowledgements

Jemma Lough, Independent Medical Writer, helped draft this guideline.

References

  1. British Thoracic Society/Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. SIGN 158. Edinburgh: SIGN, 2019. Available at: www.brit-thoracic.org.uk/quality-improvement/guidelines/asthma/
  2. Asthma UK. Patient safety failures in asthma care: the scale of unsafe prescribing in the UK. Available from: www.asthma.org.uk/support-us/campaigns/publications/nrad-one-year-on/
  3. NICE. Asthma: diagnosis, monitoring and chronic asthma management. NICE Guideline 80. NICE, 2017. Available at: www.nice.org.uk/ng80
  4. Royal College of Physicians (RCP). Why asthma still kills: the National Review of Asthma Deaths (NRAD). London: RCP, 2014. Available from: www.rcplondon.ac.uk/projects/outputs/why-asthma-still-kills
  5. Drake S, Simpson A, Fowler S. Asthma diagnosis: the changing face of guidelines. Pulm Ther 2019; 5: 103–115.
  6. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention, 2019. GINA, 2019. Available from: www.ginasthma.org
  7. Barnes P. Inhaled corticosteroids. Pharmaceuticals 2010; 3 (3): 514–540.
  8. Usmani O, Capstick T, Chowhan H, Scullion J. Choosing an appropriate inhaler device for the treatment of adults with asthma or COPD.www.guidelines.co.uk/respiratory/inhaler-choice-guideline/252870.article (accessed 24 March 2020)
  9. Price D, Román-Rodríguez M, McQueen R et al. Inhaler errors in the CRITIKAL study: type, frequency, and association with asthma outcomes. J Allergy Clin Immunol Pract 2017; 5 (4): 1071–1081.
  10. Sonnappa S, McQueen B, Postma D et al. Extrafine versus fine inhaled corticosteroids in relation to asthma control: a systematic review and meta-analysis of observational real-life studies. J Allergy Clin Immunol Pract 2018; 6 (3): 907–915.e7.
  11. Hillyer E, Price D, Chrystyn H et al. Harmonizing the nomenclature for therapeutic aerosol particle size: a proposal. J Aerosol Med Pulm Drug Deliv 2018; 31 (2): 111–113.
  12. Leach C, Colice G, Luskin A. Particle size of inhaled corticosteroids: Does it matter? J Allergy Clin Immunol 2009; 124 (6 Suppl): S88–93. 
  13. Stanford R, Shah M, D’Souza A et al. Short-acting β-agonist use and its ability to predict future asthma-related outcomes. Ann Allergy Asthma Immunol 2012; 109 (6): 403–407.
  14. Murphy A, Proeschal A, Brightling C et al. The relationship between clinical outcomes and medication adherence in difficult-to-control asthma. Thorax 2012; 67 (8): 751–753.
  15. Suissa S, Ernst P, Benayoun S et al. Low-dose inhaled corticosteroids and the prevention of death from asthma. N Eng J Med 2000; 343 (5): 332–336.
  16. Siddaway D. Stepping down asthma treatment: perceptions of primary care staff. Nursing Times [online] 2018; 114 (4): 18–21.
  17. Usmani O, Kemppinen A, Gardener E et al. A randomized pragmatic trial of changing to and stepping down fluticasone/formoterol in asthma. J Allergy Clin Immunol 2017; 5 (5): 1378–1387. 

Guidelines in Practice approached CIPLA EU Ltd for an educational grant to support the production of a consensus statement supplement. The grant included honoraria for the contributors. CIPLA EU Ltd has had no influence over the selection of the contributors or the content of the supplement and has reviewed it for technical accuracy and to ensure compliance with regulations. The views and opinions of the contributors are not necessarily those of CIPLA EU Ltd, or of Guidelines in Practice, its publisher, advisers, or advertisers. No part of this publication may be reproduced in any form without the permission of the publisher.

Date of preparation: March 2020

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