Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rakesh Chandra, Northwestern University

ClinicalTrials.gov Identifier:

NCT00871286

First received: March 26, 2009

Last updated: January 17, 2012

Last verified: January 2012

History of Changes

Results First Received: August 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Chronic Rhinosinusitis
Interventions:	Procedure: Pre-treatment Sinus CT Scan Procedure: Post-treatment Sinus CT Scan

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CT Scan (Sinus) Pre-tx	Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
CT Scan (Sinus) Post-tx	Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.

Participant Flow: Overall Study

	CT Scan (Sinus) Pre-tx	CT Scan (Sinus) Post-tx
STARTED	20	20
COMPLETED	20	14
NOT COMPLETED	0	6

Baseline Characteristics

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Reporting Groups

	Description
CT Scan (Sinus) Pre-tx	Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
CT Scan (Sinus) Post-tx	Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
Total	Total of all reporting groups

Baseline Measures

	CT Scan (Sinus) Pre-tx	CT Scan (Sinus) Post-tx	Total
Number of Participants [units: participants]	20	20	40
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	20	20	40
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	39 ± 13.5	38.9 ± 11.6	39 ± 12.4
Gender [units: participants]
Female	13	16	29
Male	7	4	11
Region of Enrollment [units: participants]
United States	20	20	40

Outcome Measures

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1. Primary:

Number of Participants in Compliance With Medical Recommendations [ Time Frame: 8 weeks ]

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2. Primary:

Number of Participants Having a CT Done [ Time Frame: 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Rakesh Chandra
Organization: Northwestern
phone: 312-695-8182
e-mail: rchandra@nmff.org

Publications:

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

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

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. Review. No abstract available.

Responsible Party:	Rakesh Chandra, Northwestern University
ClinicalTrials.gov Identifier:	NCT00871286 History of Changes
Other Study ID Numbers:	STU 8997, STU 8997
Study First Received:	March 26, 2009
Results First Received:	August 29, 2011
Last Updated:	January 17, 2012
Health Authority:	United States: Institutional Review Board

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