Long-term safety and efficacy of rupatadine in Japanese patients with perennial allergic rhinitis: a 52-week open-label clinical trial.

ABSTRACT: Objective: Long-term safety and efficacy of 10- and 20-mg rupatadine in Japanese patients with perennial allergic rhinitis (PAR) were investigated in a 52-week open-label study (JapicCTI-152952, clinicaltrials.jp). Methods: The rupatadine dose was fixed to 10 mg once daily for the first 2 weeks. Thereafter, the study investigator was allowed to increase the dosage to 20 mg if the response was insufficient. Safety was evaluated on the basis of treatment-emergent adverse events, laboratory findings, and vital sign measurements. The primary efficacy endpoint was changed from baseline to Week 2 in the total 4 nasal symptom score. Secondary efficacy endpoints included changes over time in ocular symptoms, patient and physician clinical overall impression, and patient quality-of-li

SUBMITTER: Okubo K 

PROVIDER: S-EPMC6567265 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature