Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)

NCT ID: NCT00406094

Last Updated: 2009-01-16

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.

Detailed Description

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Patients will receive either montelukast or placebo in the treatment of NARES. 4 visits will be conducted over 12 weeks. A history and physical will be performed at the beginning of the trial and at the end. Skin testing will be done at Visit 1. Nasal smears and lavages will be performed at every visit. Patients will be compensated for time and travel.

Conditions

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Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

montelukast

Group Type EXPERIMENTAL

montelukast

Intervention Type DRUG

10mg

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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montelukast

10mg

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Singulair

Eligibility Criteria

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Inclusion Criteria

* Aged 18 - 65 years
* Diagnosed with NARES

Exclusion Criteria

* Smokers, exposed to passive smoke
* Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Bernstein, Jonathan A., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Bernstein Clinical Research Center

Principal Investigators

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Jonathan A Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

Bernstein Allergy Group

Locations

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Bernstein Allergy Group

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan A Bernstein, MD

Role: CONTACT

513-931-0775

Facility Contacts

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Jonathan A Bernstein, MD

Role: primary

513-931-0775

Other Identifiers

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NARES

Identifier Type: -

Identifier Source: org_study_id

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