WockAIR® Place in Therapy

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ASTHMA

The concept of ‘maintenance and reliever therapy’ (known as MART) for moderate and severe asthma was introduced when it was shown that some Long-acting beta agonists such as formoterol (known as LABAs) could deliver rapid relief of symptoms similar to that achieved with salbutamol.¹ The concept allows the patient to use the same ICS/formoterol inhaler for regular maintenance therapy as well as reliever therapy, and eliminates the need for a Short-acting beta agonist (known as SABA).

WockAIR Group

As an ICS/formoterol inhaler, WockAIR® is licensed as maintenance therapy or as Maintenance and Reliever Therapy (from step three in the GINA pathway).⁷

In 2019 GINA removed SABA only treatment from its recommendations in response to these safety concerns. It now recommends that all adolescents and adults with asthma should receive ICS containing controller treatment to reduce their risk of exacerbations and to control symptoms.²

  • Allows the patient to use the same ICS/formoterol inhaler for regular maintenance therapy as well as reliever therapy, and eliminates the need for a SABA.
  • MART has been shown to be superior to higher dose budesonide/formoterol maintenance + SABA reliever in terms of severe exacerbation rates. Moreover this was achieved with a lower overall dose of ICS and similar symptom control.³
  • Elimination of SABA from the treatment regimen can help avoid the problem of SABA over use. It has been known for decades that there is a strong association between overuse of SABA inhalers and asthma mortality, with the risk dramatically rising when SABA use exceeds 2 canisters per month.⁴

As symptoms worsen patients may increase their usage of SABA at the expense of their ICS, and the SABA will not be addressing the underlying inflammatory process causing the deterioration in symptoms. Real world registry data have confirmed that overuse of SABA (defined as more than three canisters per year) is common (around 30-38% of asthma patients) and is associated with increased risks of exacerbation and mortality.⁵˒⁶

In the latest GINA 2021 guidelines, ICS formoterol is the preferred reliever choice.²

GINA asthma treatment strategy in adults and adolescents age ≥ 12 years²

Figure 7 GINA

The use of a single combination inhaler for maintenance and reliever therapy (MART) is an alternative approach to the introduction of a fixed-dose twice-daily combination inhaler which ensures an increased dosage of ICS as formoterol reliever treatment is increased. This approach might suit some individuals. It relies on the rapid onset of reliever effect with formoterol and by including a dose of inhaled corticosteroid ensures that, as the need for a reliever increases, the dose of preventer medication is also increased. This underpins the self-management plan which must be provided with a MART regime.8

COPD

Bronchodilators (beta-2 agonists and muscarinic antagonists) are central to the management of COPD and are usually given on a regular basis to control symptoms. Use of ICS in stable COPD tends to be reserved for those with moderate to severe disease, where ICS/LABA combination has been shown to be more effective than either component alone in improving lung function, health status and reducing exacerbations. However this needs to be balanced against the increased risk of pneumonia.9 

GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines support use of ICS in COPD when there is a history of hospitalisations for COPD exacerbations, or ≥2 moderate exacerbations per year.9

WockAIR® can be used in such patients who have FEV1 <70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy.7

GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines support use of ICS in COPD when there is a history of hospitalisations for COPD exacerbations, or ≥2 moderate exacerbations per year, or when eosinophil counts are high (>300 cells/µl). However they should not be used in patients with a history of repeated pneumonia events.9

Currently NICE suggests that ICS/LABA should be considered in people who;10

  • have spirometrically confirmed COPD and
  • have asthmatic features/features suggesting steroid responsiveness and
  • remain breathless or have exacerbations despite:
    • having used or been offered treatment for tobacco dependence if they smoke and
    • optimised non-pharmacological management and relevant vaccinations and
    • using a short-acting bronchodilator.

For the full NICE guidelines on COPD, visit NICE.org.uk

Adverse events should be reported. Reporting forms and information can be found at: https://yellowcard.mhra.gov.uk/

Adverse events should also be reported to Wockhardt UK. Please contact us or email us at drug.safety@wockhardt.co.uk

REFERENCES

1. Seberova E and Andersson A. Oxis (formoterol given by Turbuhaler1) showed as rapid an onset of action as salbutamol given by a pMDI. Respir Med 2000: 94; 607

2. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2021. Available from www.ginasthma.org Accessed February 2024

3. Kuna P, Peters MJ, Manjra AI et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007: 61; 725-736

4. Suissa S, Ernst P,Boivin J-F,Horwitz RI, Habbick B, Cockroft 0, Blais L, McNutt M, Buist AS, Spitzer WOo A cohort analysis of excess mortality in asthma and the use of inhaled Il-agonists. Am J Respir Crit Care Med 1994;149:604-10

5. Nwaru BI, Ekström M, Hasvold P, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J 2020; 55: 1901872

6. Bloom CI, Cabrera C, Arnetorp S et al. Asthma related health outcomes associated with short acting beta-2 agonist inhaler use: an observational UK study as part of the SABINA global programme. Adv Ther 2010: 37; 4190-4208 22. NICE 2017 Asthma: diagnosis, monitoring

7. WockAIR® SmPC

8. SIGN 158 British guideline on the management of asthma July 2019

9. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for Diagnosis, Management, and prevention of chronic obstructive pulmonary disease 2021 report. Available at https://goldcopd.org Accessed February 2024

10. NICE pathways Stable COPD:inhaled therapy August 2020 Available at https://pathways.nice.org.uk/pathways/chronic-obstructive-pulmonary-disease Accessed May 2021

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Job code: AIR01/21 August 2021