Table 1.
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.