Compare the Efficacy of Levocetirizine to Montelukast in Reducing Symptoms of SAR in Sensitive Subjects Exposed to Ragweed Pollen

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Double-blind, 3 Parallel Randomized Groups, Therapeutic Confirmatory. Clinical Trial to Compare the Efficacy of Levocetirizine 5 mg and Montelukast 10 mg to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects in an EEC.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315523
• Other study ID #: A00415
• Status: Completed
• Phase: Phase 3
• First received: April 14, 2006
• Last updated: December 13, 2013
• Start date: July 2006
• Est. completion date: October 2006

Study information

• Verified date: May 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg, administered once daily during two consecutive days, on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years

• Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

• Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety

• Have used forbidden concomitant medications as defined by the protocol

Study Design

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

Related Conditions & MeSH terms

• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Levocetirizine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare efficacy of Levocetirizine 5 mg to montelukast 10 mg as measured by the mean change from baseline of major symptoms related to SAR in ragweed sensitive subjects.
Secondary	Reduction in other SAR symptoms at different time points; Safety .

External Links

•   Clinical Study Summary on UCB.com