Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrom... | NCT00406094

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

NCT00406094

Sponsor

Bernstein, Jonathan A., M.D.

Status

Unknown status

Last Update Posted

Jan 16, 2009Estimated

Enrollment

6Estimated

Phase

Phase 4

Conditions

Rhinitis

Interventions

montelukast
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Nov 30, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2009

Last Update Posted Date

Jan 16, 2009Estimated

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	montelukast	Drug: montelukast
2	Placebo Comparator	placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
montelukast	Drug	10mg	1	Singulair

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jonathan A Bernstein, MD	Contact	513-931-0775		bernsteincrc@fuse.net

Overall Officials

Name	Affiliation	Role
Jonathan A Bernstein, MD	Bernstein Allergy Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bernstein Allergy Group	Recruiting	Cincinnati	Ohio	45231	United States

Type	Date	Date Unknown
Release	Oct 30, 2014
Reset	Nov 4, 2014

Submission Tracking

Estimated Results First Submitted Date

Oct 30, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 30, 2014			Nov 4, 2014

Condition Browse Module

MeSH Terms

ID	Term
D012220	Rhinitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C093875	montelukast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided