Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites...
Brief Summary
Official Title: “Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults”
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: December 2002
Intervention(s) in this Clinical Trial
- Drug: levocetirizine dihydrochloride
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
Secondary Measures
- The change from baseline of the mean MSC score over time interval 3
- the change from baseline of the mean MSC score over time intervals 1 and 4.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- adults 18 to 55 years both inclusive
- suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
- positive RAST and/or positive skin prick test
- comply with study restrictions
Exclusion Criteria:
- known alcohol or drug addiction or abuse
- known allergy/intollerance to lactose, cellullose, cornstarch
- presence of nasal anatomical deformities leading to > 50% obstruction
- ENT infection within 30 days of the study
- use of disallowed medication
- ongoing desensitivation
- known cardiac, renal or hepatic dysfunction
- presenting allergic bronchial asthma
- use of cimetidine
- intenting to donate blood during the trial
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: UCB, Inc. Industry
Overall Clinical Trial Officials and Contacts
UCb Clinical Trial Call Center Study Director UCB, Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542607
Study ID Number: A00324
ClinicalTrials.gov Identifier: NCT00542607
Health Authority: Austria: Federal Office for Safety in Health Care
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00542607
