Recruiting

Singulair

Sponsor:

Bernstein, Jonathan A., M.D.

Code:

NCT00406094

Conditions

Rhinitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

montelukast

placebo

Study Details

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.

Conditions

Rhinitis

Study ID

NCT00406094

Start date

Nov, 2006

Status verified date

Jan, 2009

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

6 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

montelukast

placebo comparator: 2

placebo

Interventions

montelukast

10mg

placebo

placebo

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jonathan A Bernstein, MD

513-931-0775bernsteincrc@fuse.net

Locations

Bernstein Allergy Group

Recruiting

Cincinnati, Ohio, United States, 45231

Contacts

Jonathan A Bernstein, MD

513-931-0775bernsteincrc@fuse.net

Principal Investigator:

Jonathan A Bernstein, MD

More Information

Sponsor

Bernstein, Jonathan A., M.D.

Last update posted

Jan 16, 2009

Last verified

Jan, 2009

Keywords

  • NARES
  • eosinophils
  • nasal symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bernstein, Jonathan A., M.D. on 2009-01-16.