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.
| Outcome (follow-up 6 months) | Relative effect (95% CI) | Assumed risk - Control | Corresponding risk - Single inhaler (95% CI) | Participants (studies) Level of evidence |
|---|---|---|---|---|
| Patients with exacerbations causing hospitalisation | OR 0.81 (0.45 to 1.44) | 6 per 1000 | 5 per 1000(3 to 8) | 8841(8) Low |
| Patients with exacerbations treated with oral steroids | OR 0.83 (0.70 to 0.98) | 70 per 1000 | 59 per 1000(50 to 69) | 8841(8) Moderate |
| Serious adverse events (non-fatal) | OR 1.20 (0.90 to 1.60) | 20 per 1000 | 24 per 1000(18 to 32 | 8841(8) Low |
| Discontinuation due to adverse events | OR 2.85 (1.89 to 4.3) | 7 per 1000 | 21 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).
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