Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: montelukast
  • 10mg
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • montelukast
• Placebo Comparator: 2
  • placebo

Primary Measures

• Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
  • Time Frame: December 2008
    Safety Issue?: No
• Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
  • Time Frame: December 2008
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bernstein, Jonathan A., M.D.

Overall Clinical Trial Officials and Contacts

Jonathan A Bernstein, MD Principal Investigator Bernstein Allergy Group  

Overall Contact: Jonathan A Bernstein, MD 513-931-0775 bernsteincrc@fuse.net

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00406094

Study ID Number: NARES

ClinicalTrials.gov Identifier: NCT00406094

Health Authority: United States: Institutional Review Board