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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00406094
Recruitment Status : Unknown
Verified January 2009 by Bernstein, Jonathan A., M.D..
Recruitment status was:  Recruiting
First Posted : December 4, 2006
Last Update Posted : January 16, 2009
Merck Sharp & Dohme Corp.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Rhinitis Drug: montelukast Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of Singulair for the Treatment of Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Study Start Date : November 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold

Arm Intervention/treatment
Experimental: 1
Drug: montelukast
Other Name: Singulair

Placebo Comparator: 2
Drug: placebo

Primary Outcome Measures :
  1. Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES [ Time Frame: December 2008 ]
  2. Determine whether montelukast is more effective than placebo at reducing nasal symptom scores [ Time Frame: December 2008 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00406094

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Contact: Jonathan A Bernstein, MD 513-931-0775

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United States, Ohio
Bernstein Allergy Group Recruiting
Cincinnati, Ohio, United States, 45231
Contact: Jonathan A Bernstein, MD    513-931-0775   
Principal Investigator: Jonathan A Bernstein, MD         
Sponsors and Collaborators
Bernstein, Jonathan A., M.D.
Merck Sharp & Dohme Corp.
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Principal Investigator: Jonathan A Bernstein, MD Bernstein Allergy Group
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Responsible Party: Jonathan A. Bernstein, MD, Bernstein Clinical Research Center Identifier: NCT00406094    
Other Study ID Numbers: NARES
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: January 16, 2009
Last Verified: January 2009
Keywords provided by Bernstein, Jonathan A., M.D.:
nasal symptoms
Additional relevant MeSH terms:
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Common Cold
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action