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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2009 by Bernstein, Jonathan A., M.D.. Recruitment status was Recruiting

First Received on November 30, 2006. Last Updated on January 15, 2009 History of Changes

Sponsor:	Bernstein, Jonathan A., M.D.
Collaborator:	Merck
Information provided by:	Bernstein, Jonathan A., M.D.
ClinicalTrials.gov Identifier:	NCT00406094

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (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:

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
Determine whether montelukast is more effective than placebo at reducing nasal symptom scores [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Investigators

Principal Investigator:

Jonathan A Bernstein, MD

Bernstein Allergy Group

More Information

No publications provided

Responsible Party:	Jonathan A. Bernstein, MD, Bernstein Clinical Research Center
ClinicalTrials.gov Identifier:	NCT00406094 History of Changes
Other Study ID Numbers:	NARES
Study First Received:	November 30, 2006
Last Updated:	January 15, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Bernstein, Jonathan A., M.D.:

NARES
eosinophils
nasal symptoms

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Montelukast
Leukotriene Antagonists

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012