Objective: An open randomized comparative study versus loratadine was conducted in order to examine the efficacy and safety of mizolastine in the treatment of seasonal allergic rhinitis (SAR).
Method: Six-seven adult patients completed mizolastine 10 mg (34/67) and loratadine 10 mg (33/67) once daily for 14 days. Other 5 patients withdrew or dropped out from the trial.
Result: All symptom score decreased significantly after treatment in both groups. Efficacy assessment based on symptom score reducing index showed that the efficacy of Mizolastine was 82.4%, and the excellent rate was 20.6%, while the efficacy of Loratadine was 66.7%, and the excellent rate was 6.1%. No serious adverse events were reported in the two groups. The incidences of adverse drug reactions (ADRs) of Mizolastine and Loratadine were 38.2% and 33.3% respectively. The mild or moderate drowsiness and dry mouth in Mizolastine group were 26.5% and 8.8% respectively, and in Loratadine group they were 18.2% and 9.0%. There were no significant changes in laboratory examinations including blood and urine routine tests, liver and renal functions and ECG.
Conclusion: Mizolastine is effective in relieving SAR symptoms. The efficacy and ADR of mizolastine is similar to Loratadine in the treatment of SAR.