Table 3.

Changes From Baseline in End Points Averaged Over the 12 Weeks of Treatment

End PointMean Baseline ValueMean Change From BaselineLeast-Square Mean (95% CI) Difference Between GroupsP Value
Daytime asthma symptom score
 Placebo0.95−0.26
 Montelukast0.98−0.37−0.12 (−0.20 to −0.04).003
  Cough symptom score
   Placebo1.43−0.37
   Montelukast1.48−0.52−0.16 (−0.27 to −0.06.003
  Wheeze symptom score
   Placebo0.69−0.19
   Montelukast0.69−0.27−0.09 (−0.17 to −0.00).042
  Trouble breathing symptom score
   Placebo0.74−0.21
   Montelukast0.76−0.32−0.12 (−0.20 to −0.03).007
  Activity limitation symptom score
   Placebo0.73−0.17
   Montelukast0.77−0.32−0.16 (−0.25 to −0.08)<.001
 Overnight asthma symptom score*
  Placebo1.20−0.37
  Montelukast1.18−0.46−0.11 (−0.21 to −0.01).026
 Quality-of-life score—activity domain
  Placebo5.0 0.5
  Montelukast5.1 0.6 0.07 (−0.16 to 0.31).545
 Quality-of-life score—emotions domain
  Placebo5.0 0.4
  Montelukast5.1 0.5 0.12 (−0.06 to 0.31).176
 Quality-of-life score—combined domain
  Placebo5.0 0.5
  Montelukast5.1 0.6 0.10 (−0.10 to 0.29).325
 Peripheral blood eosinophil counts (103/μL)
  Placebo0.58−0.07
  Montelukast0.50−0.07−0.04 (−0.09 to −0.00).034
  • CI indicates confidence interval.

  • * In the placebo and montelukast groups, 189 and 367 patients, respectively, were included in the analysis of overnight asthma symptom scores.

  • Based on an ANCOVA, with baseline value as covariate, because of the imbalance in baseline values between the placebo and montelukast groups.