Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-29

Study Completion Date

2006-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo (PBO)

Placebo was administered orally on Days 1 and 2.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

* Pharmaceutical form: Over-encapsulated tablet
* Route of administration: Oral use

Montelukast (MLKT)

10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.

Group Type EXPERIMENTAL

Montelukast

Intervention Type DRUG

* Pharmaceutical form: Over-encapsulated tablet
* Concentration: 10 mg
* Route of administration: Oral use

Levocetirizine (LCTZ)

5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.

Group Type EXPERIMENTAL

Levocetirizine

Intervention Type DRUG

* Pharmaceutical form: Over-encapsulated tablet
* Concentration: 5 mg
* Route of administration: Oral use

Interventions

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Placebo

* Pharmaceutical form: Over-encapsulated tablet
* Route of administration: Oral use

Intervention Type DRUG

Montelukast

* Pharmaceutical form: Over-encapsulated tablet
* Concentration: 10 mg
* Route of administration: Oral use

Intervention Type DRUG

Levocetirizine

* Pharmaceutical form: Over-encapsulated tablet
* Concentration: 5 mg
* Route of administration: Oral use

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
* Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No