Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis
| Autor: | E. Ruuth, Paola Decosta, Carlos E. Baena-Cagnani, Ulrich Wahn, Pierre Scheinmann, Albert F. Finn, Claus Bachert, Gunilla Hedlin, Paul Potter, F. Estelle R. Simons, Marek L. Kowalski, Eli O. Meltzer, José Rosado Pinto |
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| Rok vydání: | 2003 |
| Předmět: |
Male
medicine.medical_specialty Allergy Evening medicine.medical_treatment Immunology Criança Nasal congestion Placebo law.invention Randomized controlled trial Double-Blind Method law Internal medicine HDE ALER Anti-Allergic Agents medicine Rinite Alérgica Immunology and Allergy Humans Child rhinorrhea Fexofenadine business.industry Rhinitis Allergic Seasonal medicine.disease Anesthesia Congestão Nasal Histamine H1 Antagonists Antihistamine Female Terfenadine medicine.symptom business Anti-Histamínicos medicine.drug |
| Zdroj: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) Agência para a Sociedade do Conhecimento (UMIC)-FCT-Sociedade da Informação instacron:RCAAP |
| ISSN: | 0091-6749 |
| Popis: | This is the first prospective, randomized, double-blind, placebo-controlled study showing statistical improvement of an H(1)-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period.This randomized, placebo-controlled, parallel-group, double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis.This study was conducted at 148 centers in 15 countries. Nine hundred thirty-five children (aged 6-11 years) were randomized and treated with either fexofenadine HCl 30 mg (n = 464) or placebo (n = 471) tablets twice a day for 14 days. Individual symptoms (sneezing; rhinorrhea; itchy nose, mouth, throat, and/or ears; itchy, watery, and/or red eyes; and nasal congestion) were assessed at baseline and then daily at 7:00 AM and 7:00 PM (+/-1 hour) during the double-blind treatment period. Each total symptom score was the sum of all symptoms, excluding nasal congestion. The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment. Safety was evaluated from adverse-event reporting, vital signs, physical examinations, and clinical laboratory data at screening and study end point.Fexofenadine was significantly superior to placebo in the primary efficacy analysis (P/=.0001). Individual symptom scores showed statistically significant superiority compared with placebo (P.05), including nasal congestion in the evening reflective assessment (P.05). There was no significant difference in adverse events between fexofenadine and placebo, either overall or by causality.The efficacy and safety of the H(1)-antihistamine fexofenadine has been confirmed in this multicenter, multinational study of children aged 6 to 11 years with seasonal allergic rhinitis. |
| Databáze: | OpenAIRE |
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