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NCT00315523 Clinical Trial

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
Secondary ID
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
Accepts healthy volunteers
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

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 .
See also
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Completed NCT00659594 - Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406) Phase 3
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