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Evidence summaries

Single Inhaler Combination of Formoterol and Budesonide Versus Inhaled Steroid Maintenance for Chronic Asthma

Single inhaler therapy combining formoterol and budesonide may reduce the risk of asthma exacerbations needing oral corticosteroids compared with inhaled corticosteroids + long-acting beta-agonist but at the cost of more discontinuations due to adverse events. Level of evidence: "C"

A Cochrane review [Abstract]1 included 13 studies with a total of 13 152 adults. There was no difference between single inhaler therapy (budesonide + formoterol) and inhaled corticosteroids (ICS) + long-cting beta-agonist (LABA) in exacerbations causing hospitalisations but the single inhaler therapy reduced exacerbations treated with oral steroids (table T1). Discontinuation due to adverse events was more common in the single inhaler group. The results for fatal serious adverse events were too rare to rule out either treatment being harmful.

Budenoside and formoterol single inhaler therapy compared to ICS + LABA

Outcome (follow-up 6 months)Relative effect (95% CI)Assumed risk - ControlCorresponding risk - Single inhaler (95% CI)Participants (studies) Level of evidence
Patients with exacerbations causing hospitalisationOR 0.81 (0.45 to 1.44)6 per 10005 per 1000(3 to 8)8841(8) Low
Patients with exacerbations treated with oral steroidsOR 0.83 (0.70 to 0.98)70 per 100059 per 1000(50 to 69)8841(8) Moderate
Serious adverse events (non-fatal)OR 1.20 (0.90 to 1.60)20 per 100024 per 1000(18 to 328841(8) Low
Discontinuation due to adverse eventsOR 2.85 (1.89 to 4.3)7 per 100021 per 1000(14 to 31)8411(7) Moderate

Another Cochrane review [Abstract] 2 included 5 studies with a total of 5 537 adult and adolescent participants. There was no difference between single inhaler fluticasone/salmeterol and single inhaler budesonide/formoterol.

Comment: The quality of evidence is downgraded by limitations in study quality (lack of blinding) and by potential reporting bias (all of the included studies are sponsored or supported by the manufacturer of the single inhaler product).

    References

    • Cates CJ, Karner C. Combination formoterol and budesonide as maintenance and reliever therapy versus current best practice (including inhaled steroid maintenance), for chronic asthma in adults and children. Cochrane Database Syst Rev 2013;(4):CD007313. [PubMed].
    • Lasserson TJ, Ferrara G, Casali L. Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children. Cochrane Database Syst Rev 2011;(12):CD004106. [PubMed]

Primary/Secondary Keywords