Chronic Rhinosinusitis
Conditions
Keywords
Chronic rhinosinusitis, Chronic sinusitis, CRS
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.
Interventions
PROCEDUREPre-treatment Sinus CT Scan
Pre-treatment Sinus CT Scan
PROCEDUREPost-treatment Sinus CT Scan
Post-treatment Sinus CT Scan
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Compliance With Medical Recommendations | 8 weeks | Number of participants in each group who complied with medical advice given at the initial appointment. |
| Number of Participants Having a CT Done | 8 weeks | Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | CT Scan (Sinus) Post-tx | CT Scan (Sinus) Pre-tx | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age Continuous | 38.9 years STANDARD_DEVIATION 11.6 | 39 years STANDARD_DEVIATION 13.5 | 39 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 8 weeks
Population: Per protocol; this was a nonpowered convenience sample
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Scan (Sinus) Pre-tx | Number of Participants Having a CT Done | 20 participants |
| CT Scan (Sinus) Post-tx | Number of Participants Having a CT Done | 9 participants |
Primary
Number of Participants in Compliance With Medical Recommendations
Number of participants in each group who complied with medical advice given at the initial appointment.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Scan (Sinus) Pre-tx | Number of Participants in Compliance With Medical Recommendations | 20 participants |
| CT Scan (Sinus) Post-tx | Number of Participants in Compliance With Medical Recommendations | 10 participants |