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COVID-19 BTS/SIGN UPDATE

Advice for healthcare professionals treating people with asthma (adults) in relation to COVID-19

What can I suggest my patients do to keep themselves healthy?

  • It is still unclear if asthma is a risk factor for COVID-19 and COVID-19 related complications— viruses are a common cause of asthma exacerbations and patients should be advised to follow all recommended precautions including social distancing and shielding when appropriate 
  • For people with asthma, the best way of staying healthy and recovering if infected with COVID-19 is to ensure their asthma is as stable as possible
  • This means taking inhaled steroids and other routine medications regularly, as prescribed and detailed in their personal asthma action plan
  • Advise patients to ensure they have a sufficient supply of their medication at home and order them in plenty of time to ensure they do not run out
  • Ensuring people have had their inhaler technique checked recently is important—this website can be useful to share with your patients: www.asthma.org.uk/advice/inhaler-videos/ 
  • Emphasise the importance of smoking cessation as current smoking has been shown to be associated with greater risk of severe complications from COVID-19 

Do inhaled corticosteroids (ICS) lower the immune system and put people at increased risk of COVID-19?

  • There is no evidence that inhaled steroids increase the risk of getting COVID-19 so please advise your patients to continue with all of their inhalers, including ICS and ICS/LABA combination inhalers

What about asthma exacerbations?

  • The management of asthma exacerbations is unchanged and patients should NOT stop taking their ICS-containing inhaler
  • Patients should be advised to take their medication as guided by their personal asthma action plan and contact their GP surgery to organise a telephone, video, or face-to-face consultation
  • If a course of steroids is clinically indicated (symptoms and signs of bronchospasm/wheeze), it should not be withheld

Reference

BTS/SIGN. Advice for healthcare professionals treating people with asthma (adults) in relation to COVID-19. Available at: www.brit-thoracic.org.uk/document-library/quality-improvement/covid-19/bts-advice-for-healthcare-professionals-treating-patients-with-asthma/

COVID-19=corona virus disease 2019; ICS=inhaled corticosteroid; LABA= long-acting ß2 adrenoceptor agonists.

Indication1

  • DuoResp® Spiromax® is indicated in adult patients (18 years of age and older) only

Asthma

  • DuoResp® Spiromax® is indicated for the regular treatment of asthma where use of a combination (inhaled corticosteroid [ICS] and long-acting ß2 adrenoceptor agonists [LABA]) is appropriate:
    • in patients not adequately controlled with ICS and ‘as needed’ inhaled short-acting ß2 adrenoceptor agonists, or
    • in patients already adequately controlled on both ICS and LABA

COPD

  • Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Dose1

  • DuoResp® Spiromax® is not intended for the initial management of asthma, or for the treatment of adult patients with only mild asthma who is not adequately controlled with ICS and ‘as needed’ inhaled short-acting ß2 adrenoceptor agonists
  • The dosage of DuoResp® Spiromax® is individual and should be adjusted to the severity of the disease
  • Patients should be reassessed regularly so that the dose of DuoResp® Spiromax® remains optimal
  • The dose should be titrated to the lowest dose at which effective control of symptoms is maintained
  • Recommended dose for adults (18 years and older):
    • one inhalation twice daily
    • some patients may require up to a maximum of two inhalations twice daily
  • DuoResp® Spiromax® is available in two strengths:
    • 160 mcg/4.5 mcg budesonide/formoterol (equivalent to a metered dose of 200 mcg/6 mcg budesonide/formoterol)
    • 320 mcg/9 mcg budesonide/formoterol (equivalent to a metered dose of 400 mcg/12 mcg budesonide/formoterol)

Method of administration1

  • DuoResp® Spiromax® is a breath actuated, inspiratory flow-driven inhaler, meaning that the active substances are delivered into the airways when the patient inhales through the mouthpiece
  • Moderate and severe asthmatic patients were shown to be able to generate sufficient inspiratory flow for DuoResp® Spiromax® to deliver the therapeutic dose
  • The use of DuoResp® Spiromax® follows three steps:
    • open—hold the device with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully open (one click is heard)
    • breathe—place the mouthpiece between the teeth with the lips closed around the mouthpiece; breathe in forcefully and deeply from the mouthpiece; remove the device from the mouth and hold the breath for 10 seconds (or as long as comfortable for the patient)
    • close—breathe out gently and close the mouthpiece cover
  • Patients should be advised to read the patient information leaflet carefully and follow the instructions as detailed

Figure 1: DuoResp® Spiromax® device

Warnings and precautions1

  • It is recommended that the dose is tapered when the treatment is discontinued, and should not be stopped abruptly
  • If patients find the treatment ineffective, or exceed the highest recommended dose, medical attention should be sought
  • Patients should be reminded to take their DuoResp® Spiromax® maintenance dose as prescribed, even when asymptomatic

Side effects1

  • The most common adverse reactions are pharmacologically predictable adverse reactions of ß2 adrenoceptor agonist therapy, such as tremor and palpitations
  • These reactions tend to be mild and usually disappear within a few days of treatment
  • For the full list of adverse reactions consult the Summary of Product Characteristics

Maintenance and reliever therapy (MART) in asthma2,3

  • DuoResp® Spiromax® 160 mcg/4.5 mcg is a MART licenced inhaler—a combination inhaler that also works as a reliever inhaler
  • MART is a form of combined ICS and LABA treatment in which a single inhaler is used for both daily maintenance therapy and the relief of symptoms when required
  • A MART inhaler needs to be taken (see Figure 2):
    • everyday, even when the patient is feeling well—to prevent the inflammation in the airways long-term, so they are less likely to react to asthma triggers
    • if the patient’s symptoms get worse—in case of cough, breathlessness, or if the patient is having an asthma attack, taking the medication helps calm down the symptoms quickly

Figure 2: MART with DuoResp® Spiromax® 160 mcg/4.5 mcg

[A] Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of DuoResp Spiromax 160 mcg/4.5 mcg as-needed inhalations. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.

Guideline recommendations

NICE3

  • In adult patients with asthma that is poorly controlled on a low dose of ICS and a leukotriene receptor antagonist (LTRA) as maintenance therapy, offer a LABA in combination with the ICS, and consider whether to continue LTRA treatment based on response
  • If asthma is uncontrolled in adult patients on a low-dose ICS and a LABA, with or without an LTRA as maintenance therapy, offer to switch to a MART regimen with a low maintenance ICS dose

BTS/SIGN4

  • Combination inhalers are recommended to ensure that a LABA is not taken without an ICS, and to improve inhaler adherence
  • In adult patients with asthma requiring initial add-on therapy who are insufficiently controlled with regular low-dose ICS preventer treatment, the addition of a LABA to an ICS (usually in a combination inhaler) is recommended to improve control
  • In selected adult patients poorly controlled with an ICS and a LABA, or with a medium-dose ICS alone, MART combining an ICS and a LABA in a single inhaler is an effective treatment regime

References

  1. Teva UK Limited. DuoResp Spiromax inhalation powder—Summary of product characteristicswww.medicines.org.uk/emc/search?q=duoresp
  2. Asthma UK. Maintenance and reliever therapy (MART)www.asthma.org.uk/advice/inhalers-medicines-treatments/inhalers-and-spacers/mart/ (Accessed 15 May 2020).
  3. NICE. Asthma: diagnosis, monitoring and chronic asthma management. NICE Guideline 80. NICE, 2017. www.nice.org.uk/guidance/ng80 (Accessed 15 May 2020).
  4. BTS/SIGN. British guideline on the management of asthma. SIGN 158. Edinburgh: BTS/SIGN, 2019. www.sign.ac.uk/assets/sign158.pdf (Accessed 15 May 2020).

DUOR-GB-00021

Date of preparation: August 2020