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Fexofenadine is Efficacious and Safe in Children (Aged 6-11 Years) with Seasonal Allergic Rhinitis

dc.contributor.authorRosado-Pinto, J
dc.contributor.authorWahn, U
dc.contributor.authorMeltzer, E
dc.contributor.authorFinn, A
dc.contributor.authorKowalski, M
dc.contributor.authorDecosta, P
dc.contributor.authorHedlin, G
dc.contributor.authorScheinmann, P
dc.contributor.authorBachert, C
dc.contributor.authorBaena-Cagnani, C
dc.contributor.authorPotter, P
dc.contributor.authorSimons, F
dc.contributor.authorRuuth, E
dc.date.accessioned2013-05-14T15:31:55Z
dc.date.available2013-05-14T15:31:55Z
dc.date.issued2003
dc.description.abstractBackground: This is the first prospective, randomized, doubleblind, placebo-controlled study showing statistical improvement of an H1-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period. Objective: This randomized, placebo-controlled, parallelgroup,double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis. Methods: 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.por
dc.identifier.citationJ Allergy Clin Immunol 2003;111:763-9por
dc.identifier.urihttp://hdl.handle.net/10400.17/1251
dc.language.isoengpor
dc.publisherElsevierpor
dc.subjectRinite Alérgicapor
dc.subjectAnti-Histamínicospor
dc.subjectCongestão Nasalpor
dc.subjectCriançapor
dc.subjectHDE ALER
dc.titleFexofenadine is Efficacious and Safe in Children (Aged 6-11 Years) with Seasonal Allergic Rhinitispor
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage769por
oaire.citation.startPage763por
oaire.citation.volume111por
rcaap.rightsopenAccesspor
rcaap.typearticlepor

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