Beaseley R, Holliday M, Reddel HK, et al.
Controlled trial of budesonide-formoterol as needed for mild asthma.

N Engl J Med 2019;380(21):2020–2030.

Although asthma exacerbations are a particular concern for those with severe asthma, they can occur across the spectrum of asthma severity.1 Exacerbations represent a substantial burden in mild asthma and can be reduced with inhaled glucocorticoid therapy.2 Nonetheless, patients are often reluctant to use prescribed maintenance treatment when they have mild and infrequent symptoms. In contrast, reliever therapy with a combination of an inhaled glucocorticoid and a fast-onset beta-agonist enables patients to use therapy as needed, thus allowing them to manage therapy according to the symptoms they are experiencing. 

There have been previous trials supporting the efficacy and safety of reliever therapy with budesonide-formoterol in mild asthma. However, these studies have lacked real-world validity, such that translating their findings to clinical practice is difficult.2 For example, they required regular inhaler use (twice a day for 12 months) to maintain blinding, but this meant patients were not using the therapy as needed. Moreover, a run-in phase during which current inhaler therapy was withdrawn meant that patients had worsened symptoms on entering the study, which does not reflect clinical practice. 

A recent study by Beasley et al.2 has addressed these concerns by conducting an open-label trial to investigate as-needed use of budesonide-formoterol reliever therapy in adults with mild asthma who were previously treated with only as-needed SABA. They compared the two as-needed treatments, hypothesizing that switching to the combination would be superior to continuation of SABA.  

The authors randomised 668 patients to receive either SABA as needed, budesonide maintenance plus SABA as needed or budesonide-formoterol as needed, and inhalers had electronic inhaler usage monitors. Patients were followed for 52 weeks to observe the rate of asthma exacerbations, defined as urgent medical care consultation, prescription of systemic glucocorticoids for any duration, or an episode of high beta-agonist use (>16 actuations of SABA or >8 actuations of budesonide-formoterol over 24 hours).

The results indicated a lower asthma exacerbation rate in the budesonide-formoterol group than in those taking SABA (P<0.001). There was no difference in exacerbation rate between the budesonide maintenance group and those taking budesonide-formoterol as needed. Moreover, there were fewer severe exacerbations in the budesonide-formoterol group compared with both other groups. 

The authors suggest that budesonide-formoterol taken as needed was superior to both as-needed SABA and maintenance budesonide plus as-needed SABA at reducing the risk of severe exacerbations. As such, therapy with budesonide-formoterol taken when the patient perceives their symptoms to be worsening can avoid symptoms becoming severe enough to warrant further urgent care. The study extends previous findings regarding the use of reliever therapy to avoid asthma exacerbations, providing evidence from a study that reflects real-world clinical practice.

This project was initiated and funded by Teva Respiratory. Teva have had no influence over content. Topics and content have been selected and written by independent experts.