[Multicenter hospital study on the efficacy of Zyrtec (R) (cetirizine) compared to a placebo, in the treatment of perennial allergic rhinitis in 254 adolescents aged 12-15].
In this multicenter parallel group randomized trial 254 teenagers, aged 12-15, suffering from perennial allergic rhinitis were investigated. Four evaluations (D-10, D0, D15, D30) were performed according to the following design: a 10-day run-in period (D-10, D0) to determine/establish the patient eligibility and to perform an allergologic checkup. The decision to include the patient was made at D0 according to selection criteria. a 30-day treatment period (D0 to D30). The patient received either cetirizine 10 mg once a day or placebo given in a double blind way according to randomization. Efficacy was assessed at each visit with a nasal symptom score (sneezing, rhinorrhea, obstruction, pruritus) and an ocular symptom score (watery eyes, conjunctival pruritus, red eyes). In addition, an objective evaluation was performed by means of anterior rhinoscopy. Global evaluations by the investigator and the patient on visual analog scales were assessed. Side effects were recorded. At baseline there was no significant difference between the two groups. At day 15 and day 30, all symptoms, subjective as well as objective, were significantly improved in the cetirizine group. Tolerance was good with no significant difference between cetirizine and placebo.
Molkhou
P
P
Hôpital Saint-Vincent de Paul, Paris.
Billardon
M
M
Jouan
A M
AM
Fondarai
J
J
D000293:Adolescent; D017332:Cetirizine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D008297:Male; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D013997:Time Factors
D017332:Cetirizine