To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-01

Study Completion Date

2006-01-18

Brief Summary

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To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0476, montelukast sodium / Duration of Treatment: 12 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
* Male or female outpatient 20 years of age and older
* Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

Exclusion Criteria

* Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
* Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
* Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
* Treated with montelukast within 3 months before enrollment
* Unable to perform acceptable, reproducible spirometry and peak flow measurement
* Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No