- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406094
Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
January 15, 2009 updated by: Bernstein, Jonathan A., M.D.
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 Overview
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 Type
Interventional
Enrollment (Anticipated)
6
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jonathan A Bernstein, MD
- Phone Number: 513-931-0775
- Email: bernsteincrc@fuse.net
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45231
- Recruiting
- Bernstein Allergy Group
-
Principal Investigator:
- Jonathan A Bernstein, MD
-
Contact:
- Jonathan A Bernstein, MD
- Phone Number: 513-931-0775
- Email: bernsteincrc@fuse.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
placebo
|
placebo
|
Experimental: 1
montelukast
|
10mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES
Time Frame: December 2008
|
December 2008
|
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores
Time Frame: December 2008
|
December 2008
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan A Bernstein, MD, Bernstein Allergy Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
November 30, 2006
First Submitted That Met QC Criteria
November 30, 2006
First Posted (Estimate)
December 4, 2006
Study Record Updates
Last Update Posted (Estimate)
January 16, 2009
Last Update Submitted That Met QC Criteria
January 15, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Picornaviridae Infections
- Nose Diseases
- Rhinitis
- Common Cold
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- NARES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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