Initial management of newly diagnosed asthma in people aged 12 and over

This content is from the BTS, NICE and SIGN guideline - Asthma: diagnosis, monitoring and chronic asthma management (SIGN 245), 2024.

1.7.1 Offer a low-dose inhaled corticosteroid (ICS)/formoterol combination inhaler to be taken as needed for symptom relief (as-needed AIR therapy) to people aged 12 and over with newly diagnosed asthma.

[BTS/NICE/SIGN 2024]

In November 2024, only certain budesonide/formoterol inhalers were licensed for as-needed AIR therapy in mild asthma. The use of any other ICS/formoterol inhalers would therefore be off-label. The current evidence supporting the use of budesonide/formoterol is based on the use of a dry powder inhaler. See NICE's information on prescribing medicines or SIGN’s information on prescribing licensed medicines outwith their marketing authorisation.

1.7.2 If the person needing asthma treatment presents highly symptomatic (for example, regular nocturnal waking) or with a severe exacerbation, start treatment with low-dose MART (maintenance and reliever therapy) in addition to treating the acute symptoms as indicated (that is, a course of oral corticosteroids may be needed). Consider stepping down to as-needed AIR therapy using a low-dose ICS/formoterol inhaler at a later date if their asthma is controlled.

[BTS/NICE/SIGN 2024]

Rationale and impact

Why the committee made the recommendations

The committee looked at evidence comparing 3 treatment options in people aged 12 and over with a new diagnosis of asthma. These were short-acting beta₂ agonists (SABA) as needed with no inhaled corticosteroid (ICS); regular low-dose ICS plus SABA as needed; and a combination inhaler of ICS plus formoterol, a fast onset long-acting beta₂ agonist (LABA), used as needed.

The most important difference between the groups was a reduction in severe exacerbations of asthma in the group using ICS/formoterol as needed, and this applied to the comparisons with both of the other treatment options. There were also fewer exacerbations with ICS plus SABA than with SABA alone. Apart from the difference in exacerbations, there were only small differences between outcomes when comparing ICS plus SABA as needed with ICS/formoterol as needed, and the committee did not assess these as clinically important. However, the evidence showed that use of ICS (either as an ICS/formoterol combination inhaler used as needed or as regular low-dose ICS plus SABA as needed) produced consistently better outcomes than SABA alone.

Health economic data showed that treatment with an ICS/LABA combination inhaler as needed was cheaper than regular ICS plus SABA as needed. The committee therefore concluded that combination inhalers used as needed should be the preferred treatment in newly diagnosed asthma in adults. However, there were concerns about the minority of people with asthma in whom the diagnosis is first made because of an acute attack. In these particularly symptomatic people, the committee agreed on safety grounds that initial treatment should be given regularly and recommended starting the low-dose MART (maintenance and reliever therapy) regimen.

How the recommendations might affect practice

Most people aged 12 and over with newly diagnosed asthma are currently treated with either a SABA alone or with regular ICS plus SABA as needed. The new recommendations represent a significant change in practice. The use of combination inhalers is more expensive than SABA alone, but cheaper than regular ICS plus SABA as needed. Therefore, the cost impact will vary depending on the predominant form of treatment in each general practice. However, there should be future savings from a reduction in severe asthma exacerbations compared with either of the current treatment options.

Full details of the evidence and the committee’s discussion are in evidence review P: drug classes for initial asthma management .