Cetirizine and pseudoephedrine retard, given alone or in combination, in patients with seasonal allergic rhinitis.

We compared the efficacy and safety of cetirizine (5 mg), pseudoephedrine retard (120 mg), and the combination of cetirizine (5 mg) with pseudoephedrine retard (120 mg), each given twice daily for two weeks to subjects with pollen-associated allergic rhinitis. The study was multicentre and of randomized, double-blind, parallel-group design. Five rhinitis symptoms were rated according to severity on a scale of 0 - 3, daily by patients and at each clinic visit by investigators. A total of 687 patients, aged 9 - 66 years (mean: 32 years) was randomised to treatment (cetirizine: 231; pseudoephedrine: 226; combination: 230). On entry, the three groups were comparable in relevant respects. The primary outcome measure was based on the five symptoms assessed by the patients over the 2-week treatment period. The combination was more effective, providing at least 20% more "comfortable days" (symptoms absent or at most mild) than cetirizine or pseudoephedrine given alone (median values: 53.3%, 30.8%, and 33.3%, respectively; p < 0.001). For nasal obstruction, the combination (mean score: 1.19) was more effective than cetirizine (mean score: 1.43; p = 0.0005), but there was little difference between the combination and pseudoephedrine (mean score: 1.22; not significant). Sneezing, rhinorrhoea, nasal and ocular pruritus were better controlled by combination (mean 4-symptom score: 0.77) than by pseudoephedrine alone (mean 4-symptom score: 1.12; p < 0.001) and also better than by cetirizine alone (mean 4-symptom score: 0.93; p < 0.001). No unexpected adverse reactions were observed. A combination of cetirizine and pseudoephedrine retard is well tolerated and superior to each given alone for moderate to severe allergic seasonal rhinitis, especially when nasal obstruction is a predominant symptom.

A placebo-controlled trial of cetirizine in seasonal allergic rhino-conjunctivitis in children aged 6 to 12 years.

A total of 124 children of both sexes aged between 6 and 12 years with pollen-associated rhino-conjunctivitis were included in a multicentre double-blind study of parallel group design to compare the effects of cetirizine 10 mg daily, given as 5 mg morning and evening for 2 weeks, with those of placebo of identical appearance. Rhinorrhea, sneezing, nasal obstruction and nasal and ocular pruritus were evaluated using symptom scores by patients on daily self-evaluation cards and by investigators who, in addition, made a global evaluation at the end of treatment. Appropriate wash-out periods for previous medicines were observed. Unchanged treatment of asthma was allowed and inhaled corticosteroids were continued in 3 placebo patients. Compliance was checked and found to be less than 80% of the prescribed dosage in 2 cetirizine patients. The mean percentage of study days when symptoms were absent or at the most mild (i.e. present but not disturbing), as reported daily by the patients, was significantly greater with cetirizine (56.2%) than placebo (29.7%). This 26.5% difference was considered clinically significant. The value of this method of expressing treatment effects in allergic rhinitis is discussed. Improvement in maximum symptom scores (severest symptoms) assessed by investigators was better for cetirizine than placebo after treatment for 1 week and 2 weeks. Improvement in individual daily symptoms was greater for cetirizine than placebo after a few days.(ABSTRACT TRUNCATED AT 250 WORDS)

Assessment of the efficacy and safety of three dose levels of cetirizine given once daily in children with perennial allergic rhinitis.

The present study compared the efficacy and safety of three dose levels of cetirizine (2.5, 5, and 10 mg) once a day with placebo over 14 days in 6-12-year-old children with perennial allergic rhinitis. The design was a double-blind, randomized, multicenter, parallel-group study. Five symptoms (sneezing, nasal discharge, nasal obstruction, nasal pruritus, and ocular pruritus) were rated according to severity by investigators at the visits and daily by patients. Eighty-three patients were randomized to placebo, 84 to 2.5 mg cetirizine, 85 to 5 mg cetirizine, and 76 to 10 mg cetirizine. Groups were comparable at inclusion. The primary efficacy variable was the percentage of days with no or only mild symptoms: at all doses, cetirizine appeared to be more effective than placebo, but a significant difference was reached only in the 10-mg group (difference in medians of 22%; P = 0.016). The test of linearity was significant (P = 0.026) for the percentage of asymptomatic days. The investigators' assessments at each visit scored the symptoms in the placebo group higher, i.e., more severe, than in the active groups, the 10-mg dose causing the greatest reduction in symptoms. Adverse events were infrequent and generally mild or moderate in severity. It was concluded that cetirizine at a 10-mg, once daily dose could be used to treat effectively 6-12-year-old children with perennial allergic rhinitis.