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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Bernstein, Jonathan A., M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406094
First Posted: December 4, 2006
Last Update Posted: October 12, 2017
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.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Bernstein, Jonathan A., M.D.
  Purpose
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 Intervention Phase
Rhinitis Drug: montelukast Drug: placebo Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Bernstein, Jonathan A., M.D.:

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

Estimated Enrollment: 6
Study Start Date: November 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
montelukast
Drug: montelukast
10mg
Other Name: Singulair
Placebo Comparator: 2
placebo
Drug: placebo
placebo

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00406094


Contacts
Contact: Jonathan A Bernstein, MD 513-931-0775 bernsteincrc@fuse.net

Locations
United States, Ohio
Bernstein Allergy Group Recruiting
Cincinnati, Ohio, United States, 45231
Contact: Jonathan A Bernstein, MD    513-931-0775    bernsteincrc@fuse.net   
Principal Investigator: Jonathan A Bernstein, MD         
Sponsors and Collaborators
Bernstein, Jonathan A., M.D.
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jonathan A Bernstein, MD Bernstein Allergy Group
  More Information

Responsible Party: Jonathan A. Bernstein, MD, Bernstein Clinical Research Center
ClinicalTrials.gov Identifier: NCT00406094     History of Changes
Other Study ID Numbers: NARES
First Submitted: November 30, 2006
First Posted: December 4, 2006
Last Update Posted: October 12, 2017
Last Verified: January 2009

Keywords provided by Bernstein, Jonathan A., M.D.:
NARES
eosinophils
nasal symptoms

Additional relevant MeSH terms:
Rhinitis
Common Cold
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Montelukast
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