NCT00871286

Brief Summary

The purpose of this research study is to determine whether or not computed tomography (CT) scans performed on patients with symptoms of chronic rhinosinusitis (CRS) but without any physical signs of the disease will (1) prove to be less expensive in the treatment and evaluation as compared to current practices, (2) avoid the use of unnecessary antibiotic prescriptions, and (3) provide a more efficient way to diagnose conditions in patients who have had CRS ruled out as a cause. The investigators hypothesize that current guidelines, when applied to subjects with symptoms of CRS in the absence of physical signs may be associated with (1) increased unnecessary prescription of antibiotics, (2) delay in further essential workup, and (3) increased overall health care costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

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

March 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 18, 2012

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

March 26, 2009

Results QC Date

August 29, 2011

Last Update Submit

January 17, 2012

Conditions

Chronic Rhinosinusitis

Keywords

Chronic rhinosinusitisChronic sinusitisCRS

Outcome Measures

Primary Outcomes (2)

  • Number of Participants in Compliance With Medical Recommendations

    Number of participants in each group who complied with medical advice given at the initial appointment.

    8 weeks

  • Number of Participants Having a CT Done

    Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.

    8 weeks

Study Arms (2)

CT scan (sinus) pre-tx

EXPERIMENTAL

Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit

Procedure: Pre-treatment Sinus CT Scan

CT scan (sinus) post-tx

OTHER

Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines

Procedure: Post-treatment Sinus CT Scan

Interventions

Pre-treatment Sinus CT ScanPROCEDURE

Pre-treatment Sinus CT Scan

CT scan (sinus) pre-tx
Post-treatment Sinus CT ScanPROCEDURE

Post-treatment Sinus CT Scan

CT scan (sinus) post-tx

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects actively meeting the symptomatic criteria for CRS as defined by the Taskforce on Rhinosinusitis but with physical and endoscopic examination that is within normal limits

You may not qualify if:

  • Subjects who are pregnant
  • Subjects with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses
  • Subjects who have had prior sinus surgery or who have been previously treated with a \>3 week course of broad spectrum antibiotics for CRS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University/Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

  • Stankiewicz JA, Chow JM. A diagnostic dilemma for chronic rhinosinusitis: definition accuracy and validity. Am J Rhinol. 2002 Jul-Aug;16(4):199-202.

    PMID: 12222944BACKGROUND

  • Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.

    PMID: 12862401BACKGROUND

  • Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, Bachert C, Baraniuk J, Baroody FM, Benninger MS, Brook I, Chowdhury BA, Druce HM, Durham S, Ferguson B, Gwaltney JM Jr, Kaliner M, Kennedy DW, Lund V, Naclerio R, Pawankar R, Piccirillo JF, Rohane P, Simon R, Slavin RG, Togias A, Wald ER, Zinreich SJ; American Academy of Allergy, Asthma and Immunology; American Academy of Otolaryngic Allergy; American Academy of Otolaryngology-Head and Neck Surgery; American College of Allergy, Asthma and Immunology; American Rhinologic Society. Rhinosinusitis: Establishing definitions for clinical research and patient care. Otolaryngol Head Neck Surg. 2004 Dec;131(6 Suppl):S1-62. doi: 10.1016/j.otohns.2004.09.067.

    PMID: 15577816BACKGROUND

Results Point of Contact

Title
Rakesh Chandra
Organization
Northwestern
rchandra@nmff.org
312-695-8182

Study Officials

  • Rakesh K Chandra, MD

    Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 30, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 18, 2012

Results First Posted

January 18, 2012

Record last verified: 2012-01

Locations

US(1)