Trial Outcomes & Findings for Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study (NCT NCT00871286)

NCT ID: NCT00871286

Last Updated: 2012-01-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2012-01-18

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	14
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	CT Scan (Sinus) Pre-tx n=20 Participants 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 n=20 Participants 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 n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	39 years STANDARD_DEVIATION 13.5 • n=5 Participants	38.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	39 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	CT Scan (Sinus) Pre-tx n=20 Participants	CT Scan (Sinus) Post-tx n=20 Participants
Number of Participants in Compliance With Medical Recommendations	20 participants	10 participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Per protocol; this was a nonpowered convenience sample

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

Outcome measures

Measure	CT Scan (Sinus) Pre-tx n=20 Participants	CT Scan (Sinus) Post-tx n=20 Participants
Number of Participants Having a CT Done	20 participants	9 participants

Adverse Events

CT Scan (Sinus) Pre-tx

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CT Scan (Sinus) Post-tx

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rakesh Chandra

Northwestern

Phone: 312-695-8182

Email: rchandra@nmff.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place