Trial Outcomes & Findings for Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps (NCT NCT02927834)
NCT ID: NCT02927834
Last Updated: 2020-12-29
Results Overview
Sinonasal outcome test to access nasal/sinus symptoms. 20 questions, each question scored 0-5. 0 meaning no symptoms, 5 worse. 0- 100 total with lower number meaning better outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
4 weeks post treatment
Results posted on
2020-12-29
Participant Flow
Participant milestones
| Measure |
Antibiotic Only
1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 6 Day Steroid
Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)
6 day Prednisone: 6 day prednisone burst
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 21 Day Steroid
Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )
Augmentin: Antibiotic augmentin for 3 weeks
21 day Prednisone: 21 day prednisone burst
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
7
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
Antibiotic Only
1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 6 Day Steroid
Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)
6 day Prednisone: 6 day prednisone burst
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 21 Day Steroid
Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )
Augmentin: Antibiotic augmentin for 3 weeks
21 day Prednisone: 21 day prednisone burst
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
2
|
Baseline Characteristics
Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps
Baseline characteristics by cohort
| Measure |
Antibiotic Only
n=7 Participants
1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 6 Day Steroid
n=6 Participants
Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)
6 day Prednisone: 6 day prednisone burst
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 21 Day Steroid
n=6 Participants
Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )
Augmentin: Antibiotic augmentin for 3 weeks
21 day Prednisone: 21 day prednisone burst
|
Total
n=19 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
53.28 years
STANDARD_DEVIATION 1 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 1 • n=7 Participants
|
41.2 years
STANDARD_DEVIATION 1 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post treatmentSinonasal outcome test to access nasal/sinus symptoms. 20 questions, each question scored 0-5. 0 meaning no symptoms, 5 worse. 0- 100 total with lower number meaning better outcome
Outcome measures
| Measure |
Antibiotic Only
n=7 Participants
1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 6 Day Steroid
n=6 Participants
Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)
6 day Prednisone: 6 day prednisone burst
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 21 Day Steroid
n=6 Participants
Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )
Augmentin: Antibiotic augmentin for 3 weeks
21 day Prednisone: 21 day prednisone burst
|
|---|---|---|---|
|
Sinonasal Outcome Test (SNOT 20)
|
50.33 Score out of total 100
Interval -2.21 to 56.29
|
53.14 Score out of total 100
Interval 1.79 to 59.92
|
37 Score out of total 100
Interval 2.85 to 39.0
|
PRIMARY outcome
Timeframe: 4 weeks post treatmentPhysical exam findings of the nasal cavity. Scored 0-12. Lower score is better
Outcome measures
| Measure |
Antibiotic Only
n=7 Participants
1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 6 Day Steroid
n=6 Participants
Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)
6 day Prednisone: 6 day prednisone burst
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 21 Day Steroid
n=6 Participants
Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )
Augmentin: Antibiotic augmentin for 3 weeks
21 day Prednisone: 21 day prednisone burst
|
|---|---|---|---|
|
Nasal Endoscopy
|
2.55 score out of total 12
Interval -2.197 to 2.974
|
3.00 score out of total 12
Interval 1.793 to 3.492
|
2.16 score out of total 12
Interval -2.37 to 3.37
|
PRIMARY outcome
Timeframe: 4 week post treatmentCT scan of the sinuses, Lund Mackay score to access severity of sinus disease on CT scan. Scored on scale 0-20 with lower score better.
Outcome measures
| Measure |
Antibiotic Only
n=7 Participants
1\. Augmentin (amoxicillin/clavulanate 875/125mg) orally (PO) twice a day for 3 weeks.
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 6 Day Steroid
n=6 Participants
Augmentin with 6 day prednisone taper (40mg PO daily (QD) for 2 days, 20mg PO QD for 2 days, 10mg PO QD for 2 days, then stop)
6 day Prednisone: 6 day prednisone burst
Augmentin: Antibiotic augmentin for 3 weeks
|
Augmentin With 21 Day Steroid
n=6 Participants
Augmentin with 21 days prednisone taper (40mg PO QD for 5 days, 30mg PO QD for 5 days, 20mg PO QD for 5 days, 10mg PO QD for 5 days, then stop. )
Augmentin: Antibiotic augmentin for 3 weeks
21 day Prednisone: 21 day prednisone burst
|
|---|---|---|---|
|
CT Scan Changes
|
10.33 score out of total 20
Interval 8.15 to 11.3
|
11 score out of total 20
Interval 7.68 to 11.8
|
11.83 score out of total 20
Interval 5.13 to 13.15
|
Adverse Events
Antibiotic Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Augmentin With 6 Day Steroid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Augmentin With 21 Day Steroid
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place