Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

Rhinitis, Allergic, Seasonal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542607
• Other study ID #: A00324
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2007
• Last updated: December 11, 2013
• Start date: September 2002
• Est. completion date: December 2002

Study information

• Verified date: September 2009
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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/intolerance to lactose, cellulose, cornstarch

• presence of nasal anatomical deformities leading to > 50% obstruction

• ENT infection within 30 days of the study

• use of disallowed medication

• ongoing desensitization

• known cardiac, renal or hepatic dysfunction

• presenting allergic bronchial asthma

• use of cimetidine

• intending to donate blood during the trial

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• levocetirizine dihydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
Secondary	The change from baseline of the mean MSC score over time interval 3
Secondary	the change from baseline of the mean MSC score over time intervals 1 and 4.

External Links

•   Clinical Study Summary on UCB.com