Investigation on the efficacy and tolerance of azelastine (HCL) nasal spray versus ebastine tablets in patients with seasonal allergic rhinitis.

Author(s): Conde Hernandez J, Palma Aguilar JL, Delgado Romero J

Affiliation(s): Regional Service of Allergy and Clinical Immunology, University Hospital Virgen Macarena, Sevilla, Spain.

Publication date & source: 1995-03, Allergol Immunopathol (Madr)., 23(2):51-7.

Publication type: Clinical Trial; Randomized Controlled Trial

We compared the efficacy and tolerance of Azelastine nasal spray (0.14 mg in each nostril twice a day) versus Ebastine tablets (10 mg) as a single night dose in a Phase IV open, randomized, parallel-group clinical trial lasting 14 days, conducted with 63 patients diagnosed of seasonal allergic rhinitis. The symptoms assessed before and after the treatment period were: sneezing, nasal pruritus, rhinorrhea, nasal obstruction, conjunctival erythema, eye pruritus, eye watering, photophobia, pharyngeal pruritus and cough. Each symptom was rated by the patients according to a 4-point scale: absent: 0, mild: 1, moderate: 2, and severe: 3. The score required to be included in the study was 8 or above. In addition, the resistance of nasal fossae was assessed, before and after the treatment, by active anterior rhinomanometry, as well as the appearance of adverse events. Both drugs were equally effective both in the control of symptoms and in decreasing the airway resistance and no statistically significant differences were observed in the variables tested in both groups. We concluded that Azelastine nasal spray is a treatment as effective as Ebastine in the relief of symptoms of seasonal allergic rhinitis, with an excellent tolerance and minimum adverse effects.