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

January 15, 2009 updated by: Bernstein, Jonathan A., M.D.

The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Recruiting
        • Bernstein Allergy Group
        • Principal Investigator:
          • Jonathan A Bernstein, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
placebo
placebo
Experimental: 1
montelukast
10mg
Other Names:
  • Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
Time Frame: December 2008
December 2008
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
Time Frame: December 2008
December 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jonathan A Bernstein, MD, Bernstein Allergy Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 16, 2009

Last Update Submitted That Met QC Criteria

January 15, 2009

Last Verified

January 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rhinitis

Clinical Trials on placebo

3
Subscribe