Leukotriene receptor antagonist in the treatment of childhood allergic rhinitis—a randomized placebo-controlled study


  • Clinical Trial Registration: CUHK_CCT00113.



This study was designed to assess the hypothesis that leukotriene receptor antagonists (LTRAs) would provide additional symptom relief in asthmatic children with persistent AR already taking regular antihistamine. The effects of 16-week treatment of LTRA in addition to fexofenadine (FEX) on persistent AR in asthmatic children were examined.

Study Design

Consecutive children with stable asthma and persistent AR were invited in this randomized, double-blind, placebo-controlled study. After a 2-week run-in period in which subjects were given FEX alone, they were randomly assigned to take LTRA or placebo in addition to FEX for 16 weeks, followed by 8 weeks of follow-up phase with FEX taken alone. Symptom scoring, rhinoscopy, acoustic rhinometry, spirometry, nasal secretion extraction and blood taking for IL-4 and IL-13 analysis were performed after a 2-week run-in and at the end of treatment.


Forty-four subjects with a median (IQR) age of 12.2 (10.1–14.1) years were recruited. At week 4 of treatment, the between-group differences in the mean changes of daytime sneezing score (mean difference (95% CI) = −0.35 (−0.59, −0.12), P = 0.004), nighttime sneezing score (mean difference (95% CI) = −0.37 (−0.62, −0.11), P = 0.007) and daytime composite score (mean difference (95% CI) = −1.08 (−1.92, −0.25), P = 0.013) were significant. Acoustic rhinometry also demonstrated a nearly significant difference in nasal volume change between groups at 16 weeks of treatment (mean difference (95% CI) = 0.572 (0.090–1.054), P = 0.021). IL-4 and IL-13 were not detected in the majority of nasal secretion or serum samples.


Additional LTRA provided a more rapid relief on sneezing at the 4-week time point. This combination therapy also maintained a greater nasal volume and this might translate to lesser nasal congestion. Pediatr Pulmonol. 2009; 44:1085–1092. ©2009 Wiley-Liss, Inc.