Dg. Tinkelman et al., TREATMENT OF SEASONAL ALLERGIC RHINITIS IN CHILDREN WITH CETIRIZINE OR CHLORPHENIRAMINE - A MULTICENTER STUDY, Pediatric asthma, allergy & immunology, 10(1), 1996, pp. 9-17
Cetirizine, a selective H-1-antagonist, has been found efficacious in
the treatment of seasonal allergic rhinitis (SAR) when given once dail
y. In the present multicenter, randomized, parallel-group study the ef
ficacy and safety of cetirizine (5-10 mg in a single dose or 2 divided
doses) and of an active control, chlorpheniramine (2 mg tid), were co
mpared in children aged 6-11 years with SAR at 4 centers. Patients rat
ed symptoms twice daily on diary cards on a 4-point scale, for sneezin
g, nasal discharge, itchy eyes, itchy nose or mouth, conjunctivitis, a
nd nasal congestion. A total symptom severity (TSS) score was derived
from all symptoms except nasal congestion. TSS score at entry was 5.8
for each treatment group and was markedly reduced after 2 weeks' treat
ment: cetirizine once daily, -2.5; cetirizine twice daily, -2.6; chlor
pheniramine -2.6; there were no statistically significant differences
between groups (p = 0.91). Individual symptoms and investigator rating
s followed this pattern. Reduction in TSS occurred after the first dos
e within the first 12 h [-1.6, -2.1, and -1.2, respectively (p < 0.03)
] confirming a rapid onset of action. There was no exacerbation of ast
hma among the 117 patients entering with mild-to-moderate asthma. Most
of the patients who experienced adverse events reported only mild-to-
moderate severity. Cetirizine, given once daily or in divided doses tw
ice daily and chlorpheniramine given 3 times daily for SAR in children
aged 6-11 years, had a rapid onset of action. Neither drug was associ
ated with worsening of asthma.