Summary of findings 2. As-required FABA/ICS inhalers compared with regular inhaled steroids for mild asthma
| As‐required FABA/ICS inhalers compared with regular inhaled steroid for mild asthma | ||||||
| Patient or population: Mild asthma Setting: Community Intervention: As‐required FABA/ICS inhalers Comparison: Regular inhaled steroid | ||||||
| Outcomes | Anticipated absolute effects$ (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with regular inhaled steroid | Risk with as-required FABA/ICS inhalers | |||||
| Exacerbations requiring systemic steroid follow‐up: 52 weeks | 81 per 1000 | 65 per 1000 (49 to 86) | OR 0.79 (0.59 to 1.07) | 8065 (4 RCTs) | ⊕⊕⊝⊝ LOW*† | Exacerbations requiring systemic steroid occurred less frequently in those treated with as-required combination inhalers than those treated with regular inhaled steroids, but the 95% CI includes no difference. |
| Hospital admission, ED and urgent care visits follow‐up: 52 weeks | 19 per 1000 | 12 per 1000 (8 to 17) | OR 0.63 (0.44 to 0.91) | 8065 (4 RCTs) | ⊕⊕⊝⊝ LOW*‡ | Fewer hospital admissions, ED attendances and urgent care visits occurred in those treated with as-required combination inhalers compared with regular inhaled steroids. |
| Asthma control assessed with: ACQ‐5, follow‐up: 52 weeks. Lower scores indicate better asthma control | The mean asthma control was −0.467 points, change from baseline | MD 0.12 points higher (0.09 higher to 0.15 higher) | ‐ | 7382 (4 RCTs) | ⊕⊕⊕⊕ HIGH | ACQ‐5 fell slightly more compared with baseline in those treated with regular inhaled steroids than those treated with combination inhalers. MCID for ACQ‐5 is 0.5 points. |
| Inhaled steroid dose assessed with: mean daily dose in μg, beclomethasone equivalent follow‐up: 52 weeks | The mean inhaled steroid dose was 257.8 µg beclomethasone equivalent per day | MD 154.51 µg/day lower (207.94 lower to 101.09 lower) | ‐ | 7180 (4 RCTs) | ⊕⊕⊕⊝ MODERATE* | Those treated with as-required combination inhalers had a lower average daily inhaled steroid dose than those treated with a regular inhaled steroid. |
| Total systemic steroid dose assessed with: mean cumulative dose of prednisolone over the course of the trial in mg follow-up: 52 weeks | The mean total systemic steroid dose was 20.97 mg prednisolone | MD 7 mg prednisolone lower (13.97 lower to 0.03 lower) | ‐ | 1330 (2 RCTs) | ⊕⊕⊕⊝ MODERATE* | Total systemic steroid exposure was similar and low in those treated with regular inhaled steroid and those treated with as-required combination inhalers. |
| Adverse events assessed with: Participants experiencing at least one adverse event follow‐up: 52 weeks | 493 per 1000 | 482 per 1000 (443 to 525) | OR 0.96 (0.82 to 1.14) | 8072 (4 RCTs) | ⊕⊕⊕⊝ MODERATE* | The proportion of participants experiencing at least one adverse event was similar in those treated with combination inhalers and those with regular inhaled steroid. |
| $The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence High certainty ⊕⊕⊕⊕: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty ⊕⊕⊕: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty ⊕⊕: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty ⊕: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. | ||||||
*Downgraded as included open label studies.
†Downgraded as heterogeneity between trials at low risk of bias in all domains and those at high risk in at least one domain.
‡Downgraded as based on a relatively small number of events.
ACS-5, Asthma Control Questionnaire‐5; ED, emergency department; FABA, fast‐acting β₂‐agonist; ICS, inhaled corticosteroid; MCID, minimum clinically important difference; MD, mean difference; RCT, randomised controlled trial.