Practica oto-rhino-laryngologica. Suppl.

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A phase III double-blind comparative study was conducted to examine the superiority of loratadine (SCH 29851), a selective Hi-receptor antagonist, to placebo and non-inferiority to ketotifen fumarate (1mg b. i. d. ) in perennial allergic rhinitis when administered at a dose of 10 mg once a day for two weeks following a one-week pretreatment observation period. Of 280 patients enrolled, two were discontinued immediately due to incorrect administration of drug and 278 were included in FAS analysis (loratadine: 102 patients, ketotifen: 107 patients, placebo: 69 patients). Some imbalance in patient background factors was observed between these groups (p< 0.15), but there was no effect on the primary efficacy variable, although effect was observed on the baseline score of 5 nasal symptoms. Since the baseline was a covariate in the analysis of all nasal symptom scores, the imbalance was adjusted and was considered not to have affected the interpretation of results.
With the score of 5 nasal symptoms (total of scores for sneezing, rhinorrhea, nasal congestion, nasal itching, and post-nasal drip) as the primary efficacy variable, the superiority of the loratadine group to placebo was examined stepwise at one week after the start of treatment. It was then examined whether there was non-inferiority to ketotifen fumarate at the end of one week and two weeks of treatment. Koch's non-parametric ANCOVA was used to analyse nasal symptom scores.
Compared to placebo, there was a significant reduction in the score of 5 nasal symptoms at the end of one week of treatment (p<0.0001), verifying the superiority of loratadine to placebo. In addition, the superiority of loratadine to placebo was also verified by the score after 3 days and at the end of 2 weeks of treatment (p =0.0422, p = 0.0226, respectively). Non-inferiority of loratadine to ketotifen fumarate was also verified at the end of one week of treatment (p =0.0062) but not at the end of two weeks of treatment.

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