Table 2

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 weeks81 per 100065 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 weeks19 per 100012 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 baselineMD 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 weeksThe mean inhaled steroid dose was 257.8 µg beclomethasone equivalent per dayMD 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 weeksThe mean total systemic steroid dose was 20.97 mg prednisoloneMD 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 weeks493 per 1000482 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.