Clinical trial report of azelastine nasal spray in the treatment of allergic rhinitis
Hong Li
Abstract
Hong Li
Abstract
To evaluate the effectiveness and safety of azelastine nasal spray compared with levocabastine in patients with allergic rhinitis. This was a multi-center, double-blind, randomized, comparative study in patients with moderate-to-severe symptoms of allergic rhinitis. 136 subjects completed azelastine (1 spray per nostril twice daily) and levocabastine (2 sprays per nostril twice daily). Subjects received 14 days treatment for Seasonal allergic rhinitis and 28 days treatment for perennial allergic rhinitis. All symptom scores decreased significantly after treatment in both groups. Global efficacy assessment showed that the efficacy of Azelastine was 82 1%, and the excellent rate was 40 3%, while the efficacy of Levocabastine was 76 8%, and the excellent rate was 20 3%. No serious adverse events were reported in the two groups. The incidences of adverse drug reactions (ADRs) of Azelastine and Levocabastine were 22 1% and 31 5% respectively. The incidence of bitter taste and dry nose in Azelastine group were 8 8% and 8 8% respectively, and in Levocabastine group the incidence of dry nose and dry mouth were 16 4% and 9 6%. Azelastine nasal spray is effective and safe in relieving allergic rhinitis symptoms.
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To evaluate the effectiveness and safety of azelastine nasal spray compared with levocabastine in patients with allergic rhinitis. This was a multi-center, double-blind, randomized, comparative study in patients with moderate-to-severe symptoms of allergic rhinitis. 136 subjects completed azelastine (1 spray per nostril twice daily) and levocabastine (2 sprays per nostril twice daily). Subjects received 14 days treatment for Seasonal allergic rhinitis and 28 days treatment for perennial allergic rhinitis. All symptom scores decreased significantly after treatment in both groups. Global efficacy assessment showed that the efficacy of Azelastine was 82 1%, and the excellent rate was 40 3%, while the efficacy of Levocabastine was 76 8%, and the excellent rate was 20 3%. No serious adverse events were reported in the two groups. The incidences of adverse drug reactions (ADRs) of Azelastine and Levocabastine were 22 1% and 31 5% respectively. The incidence of bitter taste and dry nose in Azelastine group were 8 8% and 8 8% respectively, and in Levocabastine group the incidence of dry nose and dry mouth were 16 4% and 9 6%. Azelastine nasal spray is effective and safe in relieving allergic rhinitis symptoms.
Key concepts: Azelastine, Nostril, Medicine, Nasal spray, Adverse effect, Nose, Randomized controlled trial, Nasal administration