Intranasal levocabastine for the treatment of seasonal allergic rhinitis: a multicentre, double-blind, placebo-controlled trial. 1995

R Dahl, and B Pedersen, and B Larsen
Department of Respiratory Diseases, Aarhus Hospital, Denmark.

In this international, multicentre, randomized, double-blind, parallel-group, placebo-controlled trial 262 patients participated to assess the efficacy and tolerability of levocabastine nasal spray in the treatment of seasonal allergic rhinitis. Patients were randomized to receive either twice daily 0.05% levocabastine or matching placebo nasal spray with a treatment duration of four weeks. Assessments of global therapeutic efficacy favoured levocabastine. At the end of the trial, 55% of levocabastine-treated patients considered therapeutic efficacy to be excellent or good compared to 36% of those who received placebo (p < 0.001). The corresponding values for the investigator assessments were 54% and 37% (p < 0.001), respectively. Analysis of patients' diary data showed significantly lower AUCs for all parameters in the levocabastine group (p < 0.05). Investigator assessments revealed a trend towards a greater reduction in individual symptom severity from baseline in levocabastine-treated patients compared to placebo-treated controls. Adverse experiences were reported by 21% of levocabastine-treated patients and by 19% of those who received placebo, with no statistically significant differences in incidence or type. Headache and local reactions following application were the most frequently reported adverse events. Levocabastine nasal spray appears to be effective and well-tolerated for the treatment of seasonal allergic rhinitis and is an alternative to oral antihistamines.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010880 Piperidines A family of hexahydropyridines.
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006255 Rhinitis, Allergic, Seasonal Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS. Hay Fever,Pollen Allergy,Pollinosis,Seasonal Allergic Rhinitis,Hayfever,Allergic Rhinitides, Seasonal,Allergic Rhinitis, Seasonal,Allergies, Pollen,Allergy, Pollen,Fever, Hay,Pollen Allergies,Pollinoses,Rhinitides, Seasonal Allergic,Rhinitis, Seasonal Allergic,Seasonal Allergic Rhinitides
D006634 Histamine H1 Antagonists Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. Antihistamines, Classical,Antihistaminics, Classical,Antihistaminics, H1,Histamine H1 Antagonist,Histamine H1 Receptor Antagonist,Histamine H1 Receptor Antagonists,Histamine H1 Receptor Blockaders,Antagonists, Histamine H1,Antagonists, Histamine H1 Receptor,Antihistamines, Sedating,Blockaders, Histamine H1 Receptor,First Generation H1 Antagonists,H1 Receptor Blockaders,Histamine H1 Blockers,Receptor Blockaders, H1,Antagonist, Histamine H1,Classical Antihistamines,Classical Antihistaminics,H1 Antagonist, Histamine,H1 Antagonists, Histamine,H1 Antihistaminics,Sedating Antihistamines
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000281 Administration, Intranasal Delivery of medications through the nasal mucosa. Drug Administration, Intranasal,Administration, Intranasal Drug,Administration, Nasal,Intranasal Administration,Intranasal Drug Administration,Administrations, Intranasal,Administrations, Intranasal Drug,Administrations, Nasal,Drug Administrations, Intranasal,Intranasal Administrations,Intranasal Drug Administrations,Nasal Administration,Nasal Administrations
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths

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