Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Information source: Bernstein, Jonathan A., M.D.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis
Intervention: montelukast (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bernstein, Jonathan A., M.D. Official(s) and/or principal investigator(s):
Jonathan A Bernstein, MD, Principal Investigator, Affiliation: Bernstein Allergy Group
Overall contact:
Jonathan A Bernstein, MD, Phone: 513-931-0775, Email: bernsteincrc@fuse.net
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.
Clinical Details
Official title: The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Study design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARESDetermine whether montelukast is more effective than placebo at reducing nasal symptom scores
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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)
Locations and Contacts
Jonathan A Bernstein, MD, Phone: 513-931-0775, Email: bernsteincrc@fuse.net
Bernstein Allergy Group, Cincinnati, Ohio 45231, United States; Recruiting
Jonathan A Bernstein, MD, Phone: 513-931-0775, Email: bernsteincrc@fuse.net
Jonathan A Bernstein, MD, Principal Investigator
Additional Information
Starting date: November 2006
Ending date: December 2009
Last updated: January 15, 2009
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