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. 2007 Oct;3(5):885–892.

Table 1.

Studies comparing the efficacy of montelukast vs placebo in childhood asthma

Study Design Study population Intervention Main outcome measures Conclusions
Bisgaard et al 2005 RCT, 2–5 y (n = 549) MT (4 or 5 mg) Asthma Reduced
DB intermittent asthma vs placebo, 12 mo exacerbation episodes exacerbation
Becker et al 2004 RCT, 6–14 y (n = 138) MT (5 mg) vs % change Significant
DB mild persistent asthma placebo 8 wk FEV1 improvement (p = 0.005)
Strauch et al 2003 RCT 6–14 y (n = 25) MT (5 mg) vs Sputum ECP, MT suppressed
steroid-dependent asthma placebo 4 wk sputum Eo count FeNo, Qol sputum ECP, improved QOL no change in rest of parameters
Knorr et al 2001b RCT, 2-5 y (n = 689) MT vs Clinical Clinically
DB persistent asthma placebo, 12 wk parameters of asthma control, Adverse effects. QOL scores significant, efficacy well tolerated
Knorr et al 1998 RCT, 6-14 y (n = 336) MT (5 mg) vs Morning FEV1 Significant
DB persistent asthma placebo 8 wk change improvement (p < 0.001)

Abbrevations: DB, double-blind; ECP, eosinophilic cationic protein; FeNO, fractional exhaled nitric oxide; RCT, randomized control trial; MT, montelukast; QOL, quality of life.