NCT00843869

Brief Summary

This study is focused on identifying the prevalence of passive or active smoke exposure and zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

6.5 years

First QC Date

February 12, 2009

Last Update Submit

March 24, 2015

Conditions

Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • prevalence of passive or active smoke exposure

    This study is focused on identifying the prevalence of passive or active smoke exposure and zinc deficiency in a cohort of patients who meet the objective and subjective guidelines for chronic rhinosinusitis set forth by the Sinus and Allergy Health Partnership.

    Completion of study

Study Arms (1)

Chronic Rhinosinusitis

Participants with chronic rhinosinusitis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic rhinosinusitis undergoing routine sinus and skull base surgery

You may qualify if:

  • CRS and skull base surgery patients; CRS patients that meet the objective and subjective guidelines for CRS set forth by the Sinus and Allergy Health Partnership.

You may not qualify if:

  • Ciliary dysfunction, autoimmune disease, CF or any known immunodeficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Zinc levels and hair samples will be collected.

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

RhinitisRespiratory Tract InfectionsInfectionsSinusitisParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Brad Woodworth, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

August 1, 2008

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

US(1)