Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Seasonal
Intervention: levocetirizine dihydrochloride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Marie-Etienne Pinelli, MD, Study Director, Affiliation: UCB
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Primary outcome: Change from baseline of the mean Major symptom complex score
over the last 2 hours of a 24-hour coverage
Secondary outcome: The change from baseline of the mean MSC score over time interval 3the change from baseline of the mean MSC score over time intervals 1 and 4.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: September 2002
Ending date: December 2002
Last updated: March 6, 2008
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