Vasomotor rhinitis: clinical efficacy of azelastine nasal spray in comparison with placebo
Autor: | M. Baehre, E. Deschamps, R.P. Garay, P. Gehanno, E. Garay |
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Rok vydání: | 2001 |
Předmět: |
Adult
Male medicine.medical_specialty Randomization Adolescent medicine.drug_class medicine.medical_treatment Placebo Vasomotor Rhinitis medicine Humans Nose Administration Intranasal Aged Aged 80 and over business.industry Middle Aged Dermatology Azelastine Nasal decongestant Rhinitis Vasomotor medicine.anatomical_structure Treatment Outcome Otorhinolaryngology Nasal spray Anesthesia Histamine H1 Antagonists Phthalazines Female Nasal Obstruction business H1 antagonist medicine.drug |
Zdroj: | ORL; journal for oto-rhino-laryngology and its related specialties. 63(2) |
ISSN: | 0301-1569 |
Popis: | The H1 antagonist azelastine is used in nasal sprays for the treatment of allergic rhinitis, but its therapeutic efficacy in vasomotor rhinitis is unknown. We performed a multicenter randomized double-blind placebo-controlled study of the efficacy and tolerance of azelastine nasal spray in 89 adult patients with vasomotor rhinitis (confirmed by negative Phadiatop). Following a washout period, patients were treated for 15 days with one puff three times daily per nostril of azelastine (n = 44) or placebo (n = 45) nasal spray. Efficacy was evaluated by the reduction in symptomatology and by rhinoscopy. Intent-to-treat analysis revealed better results in the azelastine group for all assessed symptoms; the significance level was reached for nasal obstruction on day 15 (p = 0.042). Using per protocol analysis (in 85 patients complying with the protocol), the significance level was reached for nasal obstruction on day 15 (p = 0.017) and for the percentage of success in rhinorrhea (p = 0.023). In the azelastine group, rhinoscopy examination showed a significantly higher reduction in the inflammatory level and edema of the nasal mucosa (p = 0.03 and 0.02 for VAS on day 15 respectively, per protocol analysis). General efficacy assessment by the physician and the patient was in favor of azelastine (with significance levels 1 antagonism or from another, not well-characterized pharmacological action of azelastine. |
Databáze: | OpenAIRE |
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