A randomized, double-blind, parallel-group study to compare the efficacy and safety of a once-daily loratadine-pseudoephedrine combination with that of a twice-daily loratadine-pseudoephedrine combination in the treatment of allergic rhinitis.
The aim of this study is to compare the efficacy and safety of a once-daily loratadine-pseudoephedrine sustained release tablet with that of a twice-daily loratadine-pseudoephedrine in the treatment of patients with allergic rhinitis. Forty-eight subjects were randomized into either the treatment or control group. The efficacy endpoint was assessed by total symptom scores (TSS). And the results were analyzed by non-inferiority testing and t-tests. Non-inferiority testing of the once daily loratadine 10 mg-pseudoephedrine 240 mg sustained release tablets to the twice-daily loratadine 5 mg-pseudoephedrine 120 mg combination tablets was not supported by statistical significance. However, both the treatment and control groups showed a significant reduction from the baseline in TSS (P < 0.05), and the difference between groups did not reach statistical significance (P > 0.05). In conclusion, once-daily and twice-daily preparations of loratadine-pseudoephedrine were comparable in efficacy and safety in the treatment of allergic rhinitis.
Chen
Yen-An
YA
Department of Otolaryngology Head and Neck surgery, Chang Gung Memorial Hospital and Chang Gung University, Taipei, Taiwan, R.O.C.
Chang
Kai-Ping
KP
Lin
Yaoh-Shiang
YS
Hao
Sheng-Po
SP
D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy*; D017336:Loratadine / Q000008:administration & dosage*; D008297:Male; D054199:Pseudoephedrine / Q000008:administration & dosage*; D012220:Rhinitis / Q000188:drug therapy*; D012449:Safety; D013997:Time Factors; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D017336:Loratadine; D054199:Pseudoephedrine