Rhinitis
Conditions
Keywords
NARES, eosinophils, nasal symptoms
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.
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.
Interventions
DRUGmontelukast
10mg
DRUGplacebo
placebo
Sponsors
Merck Sharp & Dohme LLC
Bernstein, Jonathan A., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine whether montelukast is more effective than placebo at reducing the number of nasal eosinophils associated with NARES | December 2008 |
| Determine whether montelukast is more effective than placebo at reducing nasal symptom scores | December 2008 |
Countries
United States
Contacts
Primary ContactJonathan A Bernstein, MD
Outcome results
None listed