Chronic RhinosinusitisNCT00871286
Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study
A study testing Pre-treatment Sinus CT Scan and Post-treatment Sinus CT Scan in people with Chronic Rhinosinusitis, run by Northwestern University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Pre-treatment Sinus CT Scan and Post-treatment Sinus CT Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2010
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University/Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
About this study
Official title: Role of Point-of-Care CT Scanning in Patients Presenting With Symptoms of Chronic Rhinosinusitis
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.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Pre-treatment Sinus CT Scan, Post-treatment Sinus CT Scan
- Keywords
- Chronic rhinosinusitis, Chronic sinusitis, CRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatment Sinus CT ScanProcedure or surgery
Pre-treatment Sinus CT Scan
Post-treatment Sinus CT ScanProcedure or surgery
Post-treatment Sinus CT Scan
| Study group | Role | What they receive |
|---|---|---|
| CT scan (sinus) pre-tx | Experimental | Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit Receives: 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 Receives: Procedure: Post-treatment Sinus CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Compliance With Medical Recommendations
Number of participants in each group who complied with medical advice given at the initial appointment.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh Chandra, Northwestern University
- Investigators
- Rakesh K Chandra, MD, Principal investigator, Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00871286
- Sponsor's protocol ID
- STU 8997
- Other IDs
- STU 8997
- Status last verified
- Jan 2012
- First submitted
- 26 Mar 2009
- Last updated
- 18 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 12222944Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.
PubMed 12862401Meltzer 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.
PubMed 15577816