NCT00406094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 16, 2009

Status Verified

January 1, 2009

Enrollment Period

3.1 years

First QC Date

November 30, 2006

Last Update Submit

January 15, 2009

Conditions

Rhinitis

Keywords

NARESeosinophilsnasal symptoms

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

1

EXPERIMENTAL

montelukast

Drug: montelukast

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

montelukastDRUG

10mg

Also known as: Singulair
1
placeboDRUG

placebo

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 - 65 years
  • Diagnosed with NARES

You may not qualify if:

  • Smokers, exposed to passive smoke
  • Diagnosis of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), or vasomotor rhinitis (VMR)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bernstein Allergy Group

Cincinnati, Ohio, 45231, United States

RECRUITING

MeSH Terms

Conditions

Rhinitis

Interventions

montelukast

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jonathan A Bernstein, MD

    Bernstein Allergy Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan A Bernstein, MD

CONTACT

513-931-0775bernsteincrc@fuse.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

November 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 16, 2009

Record last verified: 2009-01

Locations

US(1)