Paolo Tassinari1, Nelson R Suárez, Jorge Centeno, Janina Vergara Velásquez, Héctor Aguirre-Mariscal, Sandra N Gonzálezdíaz, Alfredo Fernández de Córdova Jerves. 1. From the 1Instituto de Immunología, Universidad Central de Venezuela; and 2Policlínica Metropolitana, Caracas, Venezuela; 3Universidad Peruana Cayetano Heredia, Lima, Perú; 4Centro Especializado San Fernando, Panamá City, Panamá; 5Hospital Angeles Pedregal, Mexico City; and 6Allergy and Clinical Immunology Department, Hospital Universitario, Monterrey, Mexico; and 7Hospital Universitario del Río, Universidad del Azuay, Cuenca, Ecuador.
Abstract
OBJECTIVE: : To determine the effectiveness of desloratadine syrup in relieving symptoms of allergic rhinitis (AR) among children in Latin America. METHODS: : In an open-label trial conducted in 5 Latin American countries, 455 children aged 6 to 12 years with seasonal or perennial AR were treated with desloratadine syrup 2.5 mg/d for 6 weeks. Thirty percent of subjects were concomitantly taking corticosteroids, and 21.3% had a history of asthma. Efficacy was measured by improvement in the Total Symptom Severity 4 questionnaire and decrease in severity of individual nasal symptoms of congestion, rhinorrhea, pruritus, and sneezing. Physicians and subjects' caregivers rated symptom improvement in a separate assessment at final visit. RESULTS: : Treatment with desloratadine led to a significant decrease in mean Total Symptom Severity 4 score, from 7.54 at baseline to 1.96 at study end (P < 0.0001), and in individual symptom scores, including congestion (P < 0.0001 for all). Similar improvements were found in groups receiving desloratadine monotherapy and desloratadine plus corticosteroids. Allergic rhinitis symptoms were rated "better" or "much better" by 94% of caregivers. Incidence of adverse events was 6%. CONCLUSIONS: : Desloratadine, with or without concomitant corticosteroids, was efficacious and safe in the treatment of AR in this group of Latin American children.
RCT Entities:
OBJECTIVE: : To determine the effectiveness of desloratadine syrup in relieving symptoms of allergic rhinitis (AR) among children in Latin America. METHODS: : In an open-label trial conducted in 5 Latin American countries, 455 children aged 6 to 12 years with seasonal or perennial AR were treated with desloratadine syrup 2.5 mg/d for 6 weeks. Thirty percent of subjects were concomitantly taking corticosteroids, and 21.3% had a history of asthma. Efficacy was measured by improvement in the Total Symptom Severity 4 questionnaire and decrease in severity of individual nasal symptoms of congestion, rhinorrhea, pruritus, and sneezing. Physicians and subjects' caregivers rated symptom improvement in a separate assessment at final visit. RESULTS: : Treatment with desloratadine led to a significant decrease in mean Total Symptom Severity 4 score, from 7.54 at baseline to 1.96 at study end (P < 0.0001), and in individual symptom scores, including congestion (P < 0.0001 for all). Similar improvements were found in groups receiving desloratadine monotherapy and desloratadine plus corticosteroids. Allergic rhinitis symptoms were rated "better" or "much better" by 94% of caregivers. Incidence of adverse events was 6%. CONCLUSIONS: : Desloratadine, with or without concomitant corticosteroids, was efficacious and safe in the treatment of AR in this group of Latin American children.
Authors: Wellington G Borges; Dennis Alexander R Burns; Maria Luísa B M Felizola; Bruno A Oliveira; Cejana S Hamu; Vanessa C Freitas Journal: J Pediatr (Rio J) Date: 2006 Mar-Apr Impact factor: 2.197
Authors: Eli O Meltzer; Alfredo A Jalowayski; Klaus Vogt; Domenic Iezzoni; Alan G Harris Journal: Ann Allergy Asthma Immunol Date: 2006-02 Impact factor: 6.347