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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00315523

Purpose

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.

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

MedlinePlus related topics: Hay Fever

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride Montelukast sodium Montelukast

U.S. FDA Resources

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 EEC.

Further study details as provided by UCB:

Primary Outcome Measures:

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 Outcome Measures:

Reduction in other SAR symptoms at different time points; Safety .

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

Eligibility

Ages Eligible for Study:	18 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: NCT00315523

Locations

Canada, Ontario

Mississauga, Ontario, Canada

Sponsors and Collaborators

UCB

Investigators

Study Director:

Marie-Etienne Pinelli, MD

UCB

More Information

No publications provided by UCB

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Patel P, Patel D. Efficacy comparison of levocetirizine vs montelukast in ragweed sensitized patients. Ann Allergy Asthma Immunol. 2008 Sep;101(3):287-94.

Study ID Numbers:	A00415
Study First Received:	April 14, 2006
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00315523 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by UCB:

Levocetirizine
Xyzal
Rhinitis

Allergic
Seasonal
Ragweed

Study placed in the following topic categories:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Cetirizine
Hormones
Histamine
Leukotriene Antagonists

Montelukast
Hypersensitivity
Histamine Antagonists
Respiratory Tract Diseases
Respiratory Tract Infections
Levocetirizine
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine phosphate
Histamine H1 Antagonists
Respiratory Hypersensitivity

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 May 07, 2009