| Outcome measure | Study, effect of ML | Effect | Comment | ||
| ML+ICS effect measure; (SE) or [95% CI] | Pl (or no Pl)+ICS effect measure; (SE) or [95% CI] | Difference between groups: Δ; (SE) or [95% CI]; p value | |||
| Symptom score (various scales) | Laviolette 199918↑↑* | −0.13 [−0.22, −0.05] | −0.02 [−0.10, 0.06] | p = 0.041 | Change from baseline, LS mean |
| Vaquerizo 200320↑ | −0.34 [−0.46, −0.22] | −0.24 [−0.37, −0.12] | Δ = −0.09 [−0.19, 0.01] p = 0.07 | ||
| Kanniess 200221↑ | −0.18 (0.11) | 0.18 (0.15) | na | ||
| Asthma-free days | Vaquerizo 200320↑↑ | 66% (57–74) | 42% (33–51) | Δ = 24% [11, 41] p = 0.001 | % of all study days, median |
| Nocturnal awakenings | Laviolette 199918↑↑ | −1.04 [−1.42, −0.67] | −0.45 [−0.85, −0.05] | p = 0.010 | Nights per week, change from baseline, LS mean |
| Vaquerizo 200320↑↑ | 26% [19, 32] | 32% [26, 39] | Δ = 7% [2, 14] p = 0.01 | Nights (%) with awakenings, LS mean | |
| Exacerbations (exacerbation events) | Laviolette 199918↑↑ | 13% [10, 17] | 18% [15, 21] | p = 0.041 | Days (%) with exacerbation, LS mean |
| Vaquerizo 200320↑↑ | 3% [2, 4] | 5% [4, 6] | Δ = 2% [1, 6] p = 0.03 | Days (%) with exacerbation, median | |
| Exacerbations | Laviolette 199918↑ | 6% [na] | 12% [na] | p = 0.055 | No of patients (%) with ⩾1 exacerbation |
| Quality of life | Vaquerizo 200320↔ | 0.60 (0.05) | 0.52 (0.05) | Δ = −0.08 (0.07) p = 0.34 | AQLQ score (7 point scale), change from baseline, mean |
| Treatment satisfaction (assessment by patients) | Laviolette 199918↔ | 1.59 [1.35, 1.83] | 1.86 [1.63, 2.10] | p = 0.085 | Change of asthma status on a 7 point scale (0 = very much better, 6 = very much worse), LS mean |
| Vaquerizo 200320↔ | 83–84% in both groups | na | Patients (%) improved on a 3 point scale (better/unchanged/worse) | ||
| All adverse events | Laviolette 199918↔ | na | na | na | No (%) of patients with ⩾1 adverse event |
| Vaquerizo 200320↔ | 140 (44%) | 125 (41%) | p = 0.37 | ||
| Riccioni 200219↔ | 2 (10%) | 2 (10%) | na | ||
| Tohda 200224↔ | 6 (7%) | 6 (7%) | p = 1.0 | ||
| Withdrawal due to adverse events | Laviolette 199918↔ | 6 (3%) | 9 (5%) | na | No of patients (%) withdrawn due to adverse events |
| Vaquerizo 200320↔ | 6 (2%) | 8 (3%) | na | ||
| Kanniess 200221↔ | 3 (12%) | 2 (8%) | na | ||
| Löfdahl 199922↔ | 4 (4%) | 9 (8%) | na | ||
*Confirmative analysis.
↑↑Montelukast better than placebo (with statistical significance); ↑montelukast better than placebo (without statistical significance); ↔montelukast comparable with placebo; ↓montelukast worse than placebo (without statistical significance); and ↓↓montelukast worse than placebo (with statistical significance).
AQLQ, Asthma Quality of Life Questionnaire; ICS, inhaled corticosteroids; LS mean, least square mean; ML, montelukast; na, not available; Pl, placebo; SE, standard error.