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Budesonide-formoterol for maintenance and as needed reliever treatment reduced asthma exacerbations
  1. Magdie L Kohn, MD, FRCPC
  1. Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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    Q In patients with asthma receiving budesonide-formoterol (B-F) for maintenance treatment, how does B-F as needed reliever treatment compare with as needed formoterol and as needed terbutaline for reducing exacerbations?

    Clinical impact ratings GP/FP/Primary care ★★★★★★☆ Paediatrics ★★★★★★☆ Respirology ★★★★★☆☆

    METHODS

    Embedded ImageDesign:

    randomised controlled trial.

    Embedded ImageAllocation:

    concealed.*

    Embedded ImageBlinding:

    blinded (patients and healthcare providers).*

    Embedded ImageFollow up period:

    12 months.

    Embedded ImageSetting:

    289 centres in 20 countries.

    Embedded ImagePatients:

    3394 patients ⩾12 years of age (mean age 42 y, 60% women) who had >1 severe asthma exacerbation in the past 12 months, had used inhaled corticosteroids (ICS) for ⩾3 months, and had an FEV1 of 50–100% of predicted normal with ⩾12% reversibility after inhalation of terbutaline, 1 mg. Exclusion criteria included respiratory infection affecting asthma and use of oral corticosteroids within 1 month of study entry.

    Embedded ImageIntervention:

    as needed treatment with B-F, 160/4.5 μg (n  =  1113); formoterol, 4.5 μg (n  =  1140); or terbutaline, 0.4 mg (n  =  1141). Patients were instructed to use their reliever medication ⩽10 inhalations per day. All patients received B-F, 160/4.5 μg, 1 inhalation twice daily for maintenance treatment.

    Embedded ImageOutcomes:

    first severe exacerbation (emergency department [ED] visit or hospital admission or need for oral steroids for ⩾3 d), total number of severe exacerbations, ED visit or hospital admission, asthma symptom scores, mild exacerbations, FEV1, PEF, and reliever medication use.

    Embedded ImagePatient follow up:

    99.6% (intention to treat analysis).

    MAIN RESULTS

    As needed combined B-F prolonged the time to first severe exacerbation compared with as needed formoterol or terbutaline. B-F also reduced the risk of severe exacerbations more than the other 2 groups (table). Compared with terbutaline alone, B-F reduced ED visits and hospital admissions and mild exacerbations (table). As needed formoterol reduced severe exacerbations more than terbutaline (table). B-F decreased asthma symptom scores, increased FEV1 and morning and evening PEF, and required fewer as needed inhalations than the other 2 groups.

    As needed budesonide-formoterol (B-F) v formoterol v terbutaline for asthma*

    CONCLUSION

    In patients with asthma, combined budesonide-formoterol for both maintenance and as needed reliever treatment reduced exacerbations better than as needed formoterol or as needed terbutaline.

    Commentary

    A combination of an ICS and a long acting β agonist (LABA) is recommended as first line maintenance therapy in patients with moderate to severe asthma.1 Within the past several years, the efficacy of B-F for reliever therapy has been evaluated. Until now, no studies have included a control group with formoterol alone. The study by Rabe et al is the first to compare B-F, formoterol, and terbutaline for reliever therapy in patients with asthma on maintenance therapy with B-F.

    The patients in this study had baseline FEV1 reversibility of 24% and continued to manifest asthma symptoms in all 3 groups, suggesting submaximal asthma control. It is possible that a higher maintenance dose of ICS plus LABA would have benefited these patients and reduced exacerbations even further. To my knowledge, only 1 study to date has compared a similar dose of B-F as maintenance and reliever therapy against higher dose B-F as fixed therapy (with formoterol as reliever therapy).2 In that study, exacerbation rates were similar between the 2 groups. A study comparing LABA, short β acting agonist (SABA), and B-F as relievers in the context of a higher maintenance dose of B-F might therefore be of interest.

    Rabe et al show that B-F as maintenance and reliever therapy is more efficacious than using a LABA or SABA for relief. In this setting, it was not previously known that both the ICS and LABA components as relievers individually result in improvements in asthma control. Nevertheless, it is still unclear as to whether this strategy is better than first maximizing asthma control with a higher fixed dose of maintenance therapy.

    References

    Footnotes

    • * See glossary.

    • For correspondence: Professor K F Rabe Leiden University Medical Centre, Leiden, The Netherlands. K.F.Rabe{at}lumc.nl

    • Source of funding: AstraZeneca.