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

Primary Purpose

Rhinitis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
montelukast
placebo
Sponsored by
Bernstein, Jonathan A., M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis focused on measuring NARES, eosinophils, nasal symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Bernstein Allergy GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

montelukast

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 30, 2006
Last Updated
January 15, 2009
Sponsor
Bernstein, Jonathan A., M.D.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00406094
Brief Title
Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Official Title
The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bernstein, Jonathan A., M.D.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis
Keywords
NARES, eosinophils, nasal symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
montelukast
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
montelukast
Other Intervention Name(s)
Singulair
Intervention Description
10mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
Time Frame
December 2008
Title
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
Time Frame
December 2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan A Bernstein, MD
Phone
513-931-0775
Email
bernsteincrc@fuse.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan A Bernstein, MD
Organizational Affiliation
Bernstein Allergy Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bernstein Allergy Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan A Bernstein, MD
Phone
513-931-0775
Email
bernsteincrc@fuse.net
First Name & Middle Initial & Last Name & Degree
Jonathan A Bernstein, MD

12. IPD Sharing Statement

Learn more about this trial

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

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