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

Phase 4

• Conditions: Rhinitis
• Interventions: Drug: placebo; Drug: montelukast

• Registration Number: NCT00406094
• Lead Sponsor: Bernstein, Jonathan A., M.D.

Brief Summary

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

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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-15
• Last Update Posted: 2009-01-16
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo
1	montelukast	montelukast

Primary Outcome Measures

Name	Time	Method
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES	December 2008
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores	December 2008

Trial Locations

Locations (1)

Bernstein Allergy Group; 🇺🇸 Cincinnati, Ohio, United States