Trial Outcomes & Findings for Comparison of Nasal Steroids After FESS in CRSwNP (NCT NCT02194062)
NCT ID: NCT02194062
Last Updated: 2018-02-08
Results Overview
SNOT22 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
32 participants
Primary outcome timeframe
6 months post-op.
Results posted on
2018-02-08
Participant Flow
Participant milestones
| Measure |
Fluticasone Nasal Spray
Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day
|
Budesonide Respule in Head Upright
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
|
Budesonide Head Forward
Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
12
|
|
Overall Study
COMPLETED
|
8
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
5
|
Reasons for withdrawal
| Measure |
Fluticasone Nasal Spray
Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day
|
Budesonide Respule in Head Upright
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
|
Budesonide Head Forward
Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
5
|
Baseline Characteristics
Comparison of Nasal Steroids After FESS in CRSwNP
Baseline characteristics by cohort
| Measure |
Fluticasone Nasal Spray
n=10 Participants
Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day
|
Budesonide Respule in Head Upright
n=10 Participants
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
|
Budesonide Head Forward
n=12 Participants
Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 1 • n=93 Participants
|
44.8 years
STANDARD_DEVIATION 1 • n=4 Participants
|
39.6 years
STANDARD_DEVIATION 1 • n=27 Participants
|
43.9 years
STANDARD_DEVIATION 1 • n=483 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
12 participants
n=27 Participants
|
32 participants
n=483 Participants
|
|
asthma
yes
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
15 participants
n=483 Participants
|
|
asthma
no
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
7 participants
n=27 Participants
|
17 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 months post-op.SNOT22 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 |
Fluticasone Nasal Spray
n=8 Participants
Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day
|
Budesonide Respule in Head Upright
n=8 Participants
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
|
Budesonide Head Forward
n=7 Participants
Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
|
|---|---|---|---|
|
SNOT-22 Scores
|
31.5 units on a scale
Interval 28.35 to 34.65
|
10.29 units on a scale
Interval 9.59 to 10.99
|
15.88 units on a scale
Interval 13.78 to 17.98
|
SECONDARY outcome
Timeframe: 6 months post-opThe Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.
Outcome measures
| Measure |
Fluticasone Nasal Spray
n=8 Participants
Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day
|
Budesonide Respule in Head Upright
n=8 Participants
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
|
Budesonide Head Forward
n=7 Participants
Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
|
|---|---|---|---|
|
Lund-Kennedy Scoring for Nasal Endoscopy
|
2.69 units on a scale
Interval 2.06 to 3.3
|
0.5 units on a scale
Interval 0.25 to 0.74
|
1.13 units on a scale
Interval 0.71 to 1.54
|
Adverse Events
Fluticasone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Budesonide Respule in Head Upright
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Budesonide Head Forward
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