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    
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.
Henry Milgrom; Barbara Kittner; Robert Lanier; Frank C Hampel
Related Documents :
7606964 - The characteristics of bronchial asthma among a young adult population.
18252914 - Age-related changes in eosinophil function in human subjects.
18681854 - A cross-sectional study on the prevalence of food allergy to eggplant (solanum melongen...
8885004 - Magnitude and determinants of short-term tachyphylaxis to methacholine in subjects with...
2228334 - Personality and alcohol and marijuana use: patterns of convergence in young adulthood.
3786514 - Fixed interval performance in weanling rats: a comparison with adult and senile subjects.
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    
Department of Pediatrics, University of Colorado Health Sciences Center, National Jewish Medical and Research Center, Denver 80206, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Age Factors
Anti-Allergic Agents / administration & dosage,  adverse effects,  therapeutic use
Body Temperature / drug effects
Child, Preschool
Cough / chemically induced
Double-Blind Method
Heart Rate / drug effects
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
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

Previous Document:  Effectiveness of maintenance bee venom immunotherapy administered at 6-month intervals.
Next Document:  Subcutaneous immunoglobulin therapy in an 11-year-old patient with common variable immunodeficiency ...