Table 1

Summary of findings 1. As-required FABA/ICS inhalers compared with as-required FABA inhalers for mild asthma

As‐required FABA/ICS inhalers compared with as‐required FABA inhalers for mild asthma
Patient or population: Mild asthma
Setting: Community
Intervention: As‐required FABA/ICS inhalers
Comparison: As‐required FABA inhalers
OutcomesAnticipated absolute effects$ (95% CI)Relative effect
(95% CI)
Number of participants
(studies)
Certainty of the evidence
(GRADE)
Comments
Risk with as-required FABA inhalersRisk with as-required FABA/ICS inhalers
Asthma exacerbation requiring systemic steroid follow‐up: 52 weeks109 per 100052 per 1000
(40 to 68)
OR 0.45, 95% CI 0.34 to 0.602997
(2 RCTs)
⊕⊕⊕⊕
HIGH*†
People with mild asthma treated with combined inhalers have substantially fewer exacerbations requiring systemic steroid than those treated with FABA alone.
Hospital admission, ED and urgent care visits follow‐up: 52 weeks34 per 100012 per 1000
(7 to 21)
OR 0.35, 95% CI 0.20 to 0.602997
(2 RCTs)
⊕⊕⊝⊝
LOW†‡
People with mild asthma treated with combined inhalers probably have substantially fewer exacerbations requiring hospital admission, ED attendance or urgent care visit than those treated with FABA alone.
Asthma control follow‐up: 52 weeks
Lower scores=better control
Mean baseline ACQ‐5 ranged from 1.1 to 1.61MD −0.15, 95% CI −0.20 to −0.102859
(2 RCTs)
⊕⊕⊕⊝
MODERATE†
MCID for ACQ‐5 is 0.5.
A third study reported no difference in asthma symptom scores between the two arms.
Inhaled steroid dose assessed with: mean daily inhaled steroid dose, μg beclomethasone equivalent follow‐up: 52 weeksThe mean inhaled steroid dose was 18.7 µg beclomethasoneMD 76.50 µg beclomethasone higher (69.40 higher to 83.60 higher)2554
(2 RCTs)
⊕⊕⊕⊝
MODERATE†
People with mild asthma treated with a combined inhaler have a higher daily inhaled steroid dose than those treated with a FABA alone.
Total systemic steroid dose assessed with: mg prednisolone total over 52 weeks follow‐up: 52 weeksThe mean total systemic steroid dose was 17.4 mg prednisoloneMD 9.90 mg prednisolone lower (19.38 lower to 0.42 lower; participants=443)443
(1 RCT)
⊕⊕⊝⊝
LOW†§
Total systemic steroid dose was similar and small in both: those given combined inhalers and those given FABA alone.
Adverse events follow‐up: 52 weeks486 per 1000437 per 1000
(402 to 473)
OR 0.82
(0.71 to 0.95)
3002
(2 RCTs)
⊕⊕⊕⊝
MODERATE†
Slightly fewer adverse events occurred in those taking combination inhalers compared with those taking FABA alone.
$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.
  • *Upgraded as large effect (OR <0.5) with fairly tight CIs.

  • †Downgraded as included open label study.

  • ‡Downgraded as based on a small number of events.

  • §Downgraded as based on one study with a relatively small number of participants.

  • ACQ-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.