Trial Outcomes & Findings for Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP) (NCT NCT02748070)
NCT ID: NCT02748070
Last Updated: 2020-08-04
Results Overview
SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Baseline, 1, week, 1 month, 3 months, and 6 months
Results posted on
2020-08-04
Participant Flow
Participant milestones
| Measure |
Prednisone
Participants received oral prednisone taper for 12 days postoperatively.
|
Placebo
Participants received oral placebo for 12 days postoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
Randomized and Treated
|
40
|
40
|
|
Overall Study
COMPLETED
|
33
|
39
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)
Baseline characteristics by cohort
| Measure |
Prednisone
n=33 Participants
Participants received oral prednisone taper for 12 days postoperatively.
|
Placebo
n=39 Participants
Participants received oral placebo for 12 days postoperatively.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 14.7 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sino-nasal Outcome Test 22 (SNOT-22)
|
43.8 score on a scale
STANDARD_DEVIATION 21.5 • n=5 Participants
|
43.0 score on a scale
STANDARD_DEVIATION 22.4 • n=7 Participants
|
43.4 score on a scale
STANDARD_DEVIATION 21.8 • n=5 Participants
|
|
Lund-Kennedy Endoscopy Score
|
3.8 score on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
2.9 score on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
3.3 score on a scale
STANDARD_DEVIATION 2.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1, week, 1 month, 3 months, and 6 monthsPopulation: Participants who completed the protocol are included in the analysis.
SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
Outcome measures
| Measure |
Prednisone
n=33 Participants
Participants received oral prednisone taper for 12 days postoperatively.
|
Placebo
n=39 Participants
Participants received oral placebo for 12 days postoperatively.
|
|---|---|---|
|
Sino-nasal Outcome Test (SNOT-22) Over Time
Baseline
|
43.8 score on a scale
Standard Deviation 21.5
|
42.9 score on a scale
Standard Deviation 22.4
|
|
Sino-nasal Outcome Test (SNOT-22) Over Time
1 week
|
39.7 score on a scale
Standard Deviation 22.5
|
38.5 score on a scale
Standard Deviation 21.2
|
|
Sino-nasal Outcome Test (SNOT-22) Over Time
1 month
|
26.6 score on a scale
Standard Deviation 20.8
|
28.6 score on a scale
Standard Deviation 18.0
|
|
Sino-nasal Outcome Test (SNOT-22) Over Time
3 months
|
28.3 score on a scale
Standard Deviation 19.5
|
20.3 score on a scale
Standard Deviation 15.2
|
|
Sino-nasal Outcome Test (SNOT-22) Over Time
6 months
|
34.2 score on a scale
Standard Deviation 20.6
|
25.2 score on a scale
Standard Deviation 19.7
|
PRIMARY outcome
Timeframe: Baseline, 1, week, 1 month, 3 months, and 6 monthsPopulation: Participants who completed the protocol are included in the analysis.
The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance.
Outcome measures
| Measure |
Prednisone
n=33 Participants
Participants received oral prednisone taper for 12 days postoperatively.
|
Placebo
n=39 Participants
Participants received oral placebo for 12 days postoperatively.
|
|---|---|---|
|
Lund Kennedy Endoscopy Score Over Time
1 month
|
3.5 score on a scale
Standard Deviation 2.7
|
3.8 score on a scale
Standard Deviation 2.6
|
|
Lund Kennedy Endoscopy Score Over Time
Baseline
|
2.9 score on a scale
Standard Deviation 2.5
|
3.8 score on a scale
Standard Deviation 3.1
|
|
Lund Kennedy Endoscopy Score Over Time
1 week
|
5.9 score on a scale
Standard Deviation 3.0
|
5.3 score on a scale
Standard Deviation 2.6
|
|
Lund Kennedy Endoscopy Score Over Time
3 months
|
1.9 score on a scale
Standard Deviation 2.1
|
2.4 score on a scale
Standard Deviation 2.1
|
|
Lund Kennedy Endoscopy Score Over Time
6 months
|
1.3 score on a scale
Standard Deviation 1.7
|
1.8 score on a scale
Standard Deviation 1.8
|
Adverse Events
Prednisone
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prednisone
n=41 participants at risk
Participants received oral prednisone taper for 12 days postoperatively.
|
Placebo
n=40 participants at risk
Participants received oral placebo for 12 days postoperatively.
|
|---|---|---|
|
Blood and lymphatic system disorders
Easy bruising
|
0.00%
0/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
7.5%
3/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Blood and lymphatic system disorders
Water retention
|
7.3%
3/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
10.0%
4/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Eye disorders
Blurry vision
|
7.3%
3/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
12.5%
5/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Gastrointestinal disorders
Increased appetite
|
9.8%
4/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
5.0%
2/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Gastrointestinal disorders
Weight gain
|
4.9%
2/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
10.0%
4/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Gastrointestinal disorders
Stomach discomfort
|
19.5%
8/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
27.5%
11/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
9.8%
4/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
22.5%
9/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Nervous system disorders
Headache
|
29.3%
12/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
45.0%
18/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Psychiatric disorders
Mood swings
|
7.3%
3/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
10.0%
4/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Psychiatric disorders
Increased aggression
|
2.4%
1/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
5.0%
2/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Psychiatric disorders
Nervouseness
|
14.6%
6/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
12.5%
5/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Psychiatric disorders
Difficulty sleeping
|
29.3%
12/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
32.5%
13/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Vascular disorders
High blood pressure
|
2.4%
1/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
2.5%
1/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
|
Respiratory, thoracic and mediastinal disorders
Nosebleed
|
2.4%
1/41 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
0.00%
0/40 • 6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place