Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
149
Ketotifen dry syrup 0.1%; 1 mg b.i.d.; for 2 weeks
Cetirizine tablet; 10 mg o.d.; for 2 weeks and 5 mg b.i.d.; for 2 weeks
Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
Time frame: TSS: 2 weeks - Safety: 3 weeks
Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating
Time frame: T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period
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