Loratadine-pseudoephedrine in children with allergic rhinitis, a controlled double-blind trial.
OBJECTIVE
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.
Serra
H A
HA
Pharmacological Department, School of Medicine, University of Buenos Aires, Argentina.
Alves
O
O
Rizzo
L F
LF
Devoto
F M
FM
Ascierto
H
H
D000293:Adolescent; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001118:Argentina / Q000453:epidemiology; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004809:Ephedrine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000187:drug effects / Q000378:metabolism; D017336:Loratadine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010919:Placebos; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D012720:Severity of Illness Index; D012882:Skin Tests; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced
D018926:Anti-Allergic Agents; D001993:Bronchodilator Agents; D010919:Placebos; D007073:Immunoglobulin E; D017336:Loratadine; D004809:Ephedrine