Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2002-05-31

Brief Summary

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This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

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Detailed Description

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Conditions

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Perennial Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

montelukast

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

montelukast 10 mg tablet orally once daily at bedtime for 6 weeks

2

cetirizine

Group Type ACTIVE_COMPARATOR

Comparator: cetirizine

Intervention Type DRUG

cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks

3

placebo

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

placebo tablet orally once daily at bedtime for 6 weeks

Interventions

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montelukast sodium

montelukast 10 mg tablet orally once daily at bedtime for 6 weeks

Intervention Type DRUG

Comparator: cetirizine

cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks

Intervention Type DRUG

Comparator: placebo

placebo tablet orally once daily at bedtime for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient has a documented clinical history of perennial allergic rhinitis
* Patient is a nonsmoker
* Patient is in good general health

Exclusion Criteria

* Patient is hospitalized
* Patient is a woman who is \<8 weeks postpartum or is breast-feeding
* Patient is a current or past abuser of alcohol or illicit drugs

Minimum Eligible Age

15 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No