Table 1.
Studies that demonstrated similar efficacy of MLK compared to ICS
| First author, year [ref] | Study duration | Patients (Age) | Drugs doses | Results |
|---|---|---|---|---|
|
Maspero, 2001[40] |
6 months |
124 pts (6–11 years) |
MLK = 5 mg /d IBDP = 300 μg /d |
Higher satisfaction for MLK vs IBPD with higher compliance. Similar: oral CS use, safety, FEV1 change, asthma-related medical resource utilization, school absenteeism, parental work loss. |
|
Williams, 2001[41] |
37 weeks |
112 pts (6–14 years) |
MLK = 5 mg /d IBDP = 300 μg /d |
Similar improvement in multiple parameters of asthma control and in daytime symptom scores. |
|
Stelmach, 2002[42] |
8 weeks |
91 pts (12 ± 1.7 years) |
TRC = 400 μg /d MLK = 5 mg/d FMT = 24 μg /d |
With TRC and MLK: IL-10 level increased, EOS and ECP levels significantly decreased, all clinical parameters improved, with no significant difference in clinical score improvement. |
|
Karaman, 2004[43] |
14 weeks |
63 pts (8–14 years) |
MLK = 5 mg /d IBD = 400 μg /d MLK + IBD |
MLK improvement: airway obstruction, DSS, β2-a use, nocturnal awakenings, asthma exacerbations, ULKE4 levels. |
|
Stelmach, 2005[44] |
6 months |
51 pts (6–18 years) |
IBD = 400 μg /d IBD = 800 μg /d MLK = 5 mg/d |
ICS (high dose) and MLK significantly decreased total and specific IgE levels. Clinical score/FEV1 significantly improved with medium (p = 0.002) and high dose (p = 0.001) of IBD and MLK (p = 0.002). |
|
Garcia Garcia, 2005[45] |
12 months |
994 pts (6–14 years) |
MLK = 5 mg/d FP = 100 μg /d |
Significantly greater improvement of RFDs with FP vs MLK, but inferior to the limits (−7%) fixed for judging MLK inferior to FP, so MLK was not inferior to FP in % of asthma RFDs because the adjusted difference was −2.8%. |
|
Kumar, 2007[46] |
12 weeks |
62 pts (5–15 years) |
IBD = 400 μg/d MLK = 5 mg/d |
The median % predicted FEV1 was similar in the two groups (p = 0.44), similar improvement in clinical symptom scores; no significant difference in the need for rescue drugs. |
|
Stelmach, 2007[47] |
4 weeks |
87 pts (6–18 years) |
MLK = 5–10 mg /d IBD = 200 μg /d MLK + IBD |
Lung function improved significantly in all groups, with no significant difference in improvement. |
| Kooi, 2008[48] | 3 months | 63 pts (2–6 years) | MLK = 4 mg/day FP = 200 μg/d Placebo | FP had beneficial effect on symptoms (vs placebo, p = 0.021), MLK on EOS vs placebo (p = 0.045). No differences between FP and MLK in lung function parameters, except for FOT. |
β2-a, β2 agonist; DSS, daily symptom scores; ECP, eosinophil cationic protein; EOS, eosinophil blood counts; FEV1, forced expiratory volume in 1 s; FMT, formoterol; FOT, Forced Oscillation Tecnique; FP, fluticasone propionate; IBD, inhaled budesonide; IBDP, inhaled beclomethasone; ICS, inhaled corticosteroids; MLK, montelukast; pts, patients; RFDs, rescue-free days; TRC, triamcinolone ULKE4, urinary leukotriene E4.