Summary of findings for the main comparison. 160/4.5 mcg BDF single inhaler therapy compared to current best practice for adult asthma that is not controlled on ICS.
| 160/4.5 µgBDF single inhaler therapy compared to current best practice for adults with asthma that is not controlled on ICS | ||||||
| Patient or population: adults with asthma that is not controlled on ICS Settings: community Intervention: 160/4.5 µg BDF single inhaler therapy Comparison: current best practice | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Current best practice | 160/4.5 µgBDF single inhaler therapy | |||||
| Patients with exacerbations causing hospitalisation Follow‐up: mean 6 months | 6 per 1000 | 5 per 1000 (3 to 8) | OR 0.81 (0.45 to 1.44) | 8841 (8 studies) | ⊕⊕⊝⊝ low1,2 | |
| Patients with exacerbations treated with oral steroids Follow‐up: mean 6 months | 70 per 1000 | 59 per 1000 (50 to 69) | OR 0.83 (0.70 to 0.98) | 8841 (8 studies) | ⊕⊕⊕⊝ moderate1 | |
| Fatal serious adverse events Follow‐up: mean 6 months | 1 per 1000 | 1 per 1000 (0 to 5) | OR 1.95 (0.53 to 7.21) | 8841 (8 studies) | ⊕⊕⊝⊝ low1,2 | |
| Serious adverse events (non‐fatal) Follow‐up: mean 6 months | 20 per 1000 | 24 per 1000 (18 to 32) | OR 1.20 (0.90 to 1.60) | 8841 (8 studies) | ⊕⊕⊝⊝ low1,2 | |
| Discontinuation due to adverse events Follow‐up: mean 6 months | 7 per 1000 | 21 per 1000 (14 to 31) | OR 2.85 (1.89 to 4.3) | 8411 (7 studies) | ⊕⊕⊕⊝ moderate1 | |
| *The basis for the assumed risk is the mean control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio; | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Unblinded trials 2 Confidence interval cannot rule out important differences in either direction
BDF: budesonide plus formoterol; ICS: inhaled corticosteroids