Loratadine-pseudoephedrine in children with allergic rhinitis, a controlled double-blind trial.

AIMS: To conduct a randomized placebo controlled double-blind crossover trial in order to evaluate a loratadine-pseudoephedrine combination (L + PS) in children with seasonal allergic rhinitis.

METHODS

Forty children (15 males; 25 females), aged 3-15 years, were included in this study. They were randomized to receive L + PS (0.2 mg kg[-1] body weight-2.4 mg kg[-1] body weight respectively) or placebo (PLA) for 14 days. After 7 days of washout, patients were shifted to the other treatment for a further 14 days. Nasal symptoms (sneezing/itching, congestion, nasal dripping) and signs (turbinal swelling, retronasal drainage), rated on a scale ranging from: 1. absent to 5. very intense, and their sum or mean total symptom score (MTSS) were used as efficacy measurement.

RESULTS

Significant relief was observed; post-treatment MTSS difference and its percent change were respectively; L + PS = -4.29; 95% CI: -3.64 and -4.94 (27.8%), and PLA = -1.63; 95% CI: -0.95 and -2.31 (10.7%) (P < 0.001 baseline vs endpoint and between treatments). Furthermore, L + PS and PLA significantly modified symptoms, but only L + PS significantly modified signs. No clinical changes were observed during the trial; only one patient showed slight transient insomnia when receiving L + PS.

CONCLUSIONS

It is concluded that L + PS is useful and well tolerated in children with seasonal allergic rhinitis. However, elements such as placebo effect must be taken into account for planning future trials.