Document Detail


Safety and tolerability of fexofenadine for the treatment of allergic rhinitis in children 2 to 5 years old.
MedLine Citation:
PMID:  17941284     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The safety of fexofenadine has been examined extensively in adults and school-age children. However, the safety of fexofenadine in children younger than 6 years has not been reported to date. OBJECTIVE: To compare the safety and tolerability of twice-daily fexofenadine hydrochloride, 30 mg, and placebo in preschool children aged 2 to 5 years with allergic rhinitis. METHODS: This was a multicenter, double-blind, randomized, placebo-controlled, parallel-group study, conducted between February 29, 2000, and June 14, 2001. Participants were randomized to either fexofenadine hydrochloride, 30 mg, or placebo twice daily for a 2-week period. To facilitate dosing, capsule content was mixed with applesauce (approximately 10 mL). Safety assessments depended on date of entry into the study because of an amendment to the protocol. Before the amendment, assessments included physical examination, vital signs reporting (oral temperature, heart rate, and respiratory rate), and adverse event (AE) reporting. After the amendment, safety assessments included laboratory testing (blood chemistry and hematology profiles), physical examination, 12-lead electrocardiography, and vital signs (oral temperature, blood pressure, heart rate, and respiratory rate) and AE reporting. RESULTS: Treatment-emergent AEs were observed in 116 of 231 participants receiving placebo and 111 of 222 receiving fexofenadine. These AEs were possibly related to study medication in 19 (8.2%) and 21 (9.5%) of the participants receiving placebo and fexofenadine, respectively, and most frequently involved the digestive system. No clinically relevant differences in laboratory measures, vital signs, and physical examinations were observed. CONCLUSIONS: The findings show that fexofenadine hydrochloride, 30 mg, is well tolerated and has a good safety profile in children aged 2 to 5 years with allergic rhinitis.
Authors:
Henry Milgrom; Barbara Kittner; Robert Lanier; Frank C Hampel
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology     Volume:  99     ISSN:  1081-1206     ISO Abbreviation:  Ann. Allergy Asthma Immunol.     Publication Date:  2007 Oct 
Date Detail:
Created Date:  2007-10-18     Completed Date:  2007-12-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9503580     Medline TA:  Ann Allergy Asthma Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  358-63     Citation Subset:  IM    
Affiliation:
Department of Pediatrics, University of Colorado Health Sciences Center, National Jewish Medical and Research Center, Denver 80206, USA. milgromh@njc.org
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MeSH Terms
Descriptor/Qualifier:
Age Factors
Anti-Allergic Agents / administration & dosage,  adverse effects,  therapeutic use
Body Temperature / drug effects
Child, Preschool
Cough / chemically induced
Double-Blind Method
Electrocardiography
Female
Heart Rate / drug effects
Humans
Infant
Male
Rhinitis, Allergic, Perennial / drug therapy*,  physiopathology
Rhinitis, Allergic, Seasonal / drug therapy*,  physiopathology
Terfenadine / administration & dosage,  adverse effects,  analogs & derivatives*,  therapeutic use
Treatment Outcome
Vomiting / chemically induced
Chemical
Reg. No./Substance:
0/Anti-Allergic Agents; 138452-21-8/fexofenadine; 50679-08-8/Terfenadine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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