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

Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00406094
• Other study ID #: NARES
• Status: Unknown status
• Phase: Phase 4
• First received: November 30, 2006
• Last updated: January 15, 2009
• Start date: November 2006
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Bernstein, Jonathan A., M.D.
• Contact: Jonathan A Bernstein, MD
• Phone: 513-931-0775
• Email: bernsteincrc[@]fuse.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 6
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Common Cold
• Rhinitis

Intervention

Drug:
• montelukast
10mg
• placebo
placebo

Locations

Country	Name	City	State
United States	Bernstein Allergy Group	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Bernstein, Jonathan A., M.D.	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES		December 2008
Primary	Determine whether montelukast is more effective than placebo at reducing nasal symptom scores		December 2008