Table 1 Studies that demonstrated similar efficacy of MLK compared to ICS
From: Montelukast versus inhaled corticosteroids in the management of pediatric mild persistent asthma
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. |