Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing SAR Symptoms in Ragweed Sensitive Subjects

This study has been completed.

First Received: February 20, 2006 Last Updated: September 9, 2009 History of Changes

Sponsor:	UCB, Inc.
Information provided by:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00295022

Purpose

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.

Condition	Intervention	Phase
Rhinitis, Allergic, Seasonal	Drug: Levocetirizine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
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 EEU.

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Compare the efficacy of Levocetirizine to montelukast as measured by the mean change from baseline of major symptoms (mean value) related to Seasonal Allergic Rhinitis.

Secondary Outcome Measures:

Efficacy of each active arm in reducing other SAR symptoms (calculated as mean value reduction for grouped symptoms and as absolute value reduction for each individual symptom), at different time points; Safety

Estimated Enrollment:	403
Study Start Date:	August 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295022

Locations

Canada, Ontario

Kingston, Ontario, Canada

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

UCB, Inc.

More Information

Additional Information:

Study Summary on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A00414
Study First Received:	February 20, 2006
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00295022 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by UCB, Inc.:

Levocetirizine
Xyzal
Rhinitis

Allergic
Seasonal
Ragweed

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Rhinitis
Leukotriene Antagonists
Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Levocetirizine
Therapeutic Uses
Otorhinolaryngologic Diseases

Immune System Diseases
Anti-Asthmatic Agents
Histamine Agents
Anti-Allergic Agents
Cetirizine
Nose Diseases
Pharmacologic Actions
Montelukast
Histamine Antagonists
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010