Trial Outcomes & Findings for Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps (NCT NCT01732536)
NCT ID: NCT01732536
Last Updated: 2018-07-20
Results Overview
Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in
COMPLETED
PHASE2/PHASE3
100 participants
90 days
2018-07-20
Participant Flow
Patients were enrolled between January 2013 and November 2013 at 18 clinical sites (12 private, 6 academic).
A total of 100 patients were enrolled and randomized. met final eligibility. There was a 2-week run-in period before screening during which participants were required to use an intranasal corticosteroid spray.
Participant milestones
| Measure |
Treatment
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
|
Control
In-office bilateral sham procedure
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
47
|
|
Overall Study
COMPLETED
|
52
|
46
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Treatment
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
|
Control
In-office bilateral sham procedure
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
Baseline characteristics by cohort
| Measure |
Treatment
n=53 Participants
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 Participants
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 12.61 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 13.12 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3%) participants (1 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.
Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in
Outcome measures
| Measure |
Treatment
n=53 Participants
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 Participants
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Nasal Obstruction/Congestion Score
Baseline
|
3.62 units on a scale
Standard Deviation 1.180
|
3.30 units on a scale
Standard Deviation 1.159
|
|
Nasal Obstruction/Congestion Score
Day 90
|
2.31 units on a scale
Standard Deviation 1.422
|
2.62 units on a scale
Standard Deviation 1.336
|
|
Nasal Obstruction/Congestion Score
Change from baseline
|
-1.33 units on a scale
Standard Deviation 1.465
|
-0.67 units on a scale
Standard Deviation 1.446
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 2 (2%) participants (2 treatment, 0 control) with missing values. No imputation of missing values was performed. Negative values for change from baseline represent improvement.
Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.
Outcome measures
| Measure |
Treatment
n=53 Participants
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 Participants
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Bilateral Polyp Grade
Baseline
|
4.90 units on a scale
Standard Deviation 0.918
|
4.39 units on a scale
Standard Deviation 1.448
|
|
Bilateral Polyp Grade
Day 90
|
4.12 units on a scale
Standard Deviation 1.162
|
4.00 units on a scale
Standard Deviation 1.720
|
|
Bilateral Polyp Grade
Change from baseline
|
-0.76 units on a scale
Standard Deviation 0.875
|
-0.38 units on a scale
Standard Deviation 0.998
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There was1 (1.0%) participant (treatment) with missing values at baseline and Day 90. No imputation of missing values was performed.
Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.
Outcome measures
| Measure |
Treatment
n=53 Participants
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 Participants
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Ethmoid Sinus Obstruction
Baseline
|
70.59 units on a scale
Standard Deviation 18.201
|
62.74 units on a scale
Standard Deviation 25.673
|
|
Ethmoid Sinus Obstruction
Day 90
|
53.54 units on a scale
Standard Deviation 20.140
|
57.17 units on a scale
Standard Deviation 28.516
|
|
Ethmoid Sinus Obstruction
Change from baseline
|
-17.05 units on a scale
Standard Deviation 19.361
|
-5.57 units on a scale
Standard Deviation 18.279
|
SECONDARY outcome
Timeframe: 90 days, 6 monthsPopulation: Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at 90 days and 4 (4.0%) participants (2 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.
Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.
Outcome measures
| Measure |
Treatment
n=53 Participants
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 Participants
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Bilateral Polyp Grade
Baseline
|
4.68 units on a scale
Standard Error 0.956
|
4.32 units on a scale
Standard Error 1.105
|
|
Bilateral Polyp Grade
90 days
|
3.65 units on a scale
Standard Error 1.655
|
4.24 units on a scale
Standard Error 1.667
|
|
Bilateral Polyp Grade
Change from baseline to 90 days
|
-1.04 units on a scale
Standard Error 1.680
|
-0.09 units on a scale
Standard Error 1.203
|
|
Bilateral Polyp Grade
Month 6
|
3.96 units on a scale
Standard Error 1.587
|
4.36 units on a scale
Standard Error 1.708
|
|
Bilateral Polyp Grade
Change from baseline to 6 months
|
-0.71 units on a scale
Standard Error 1.527
|
0.02 units on a scale
Standard Error 1.158
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.
NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.
Outcome measures
| Measure |
Treatment
n=53 Participants
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 Participants
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Nasal Obstruction Symptom Evaluation (NOSE) Score
Baseline
|
66.79 units on a scale
Standard Deviation 26.658
|
63.19 units on a scale
Standard Deviation 23.943
|
|
Nasal Obstruction Symptom Evaluation (NOSE) Score
Month 6
|
41.83 units on a scale
Standard Deviation 24.395
|
50.67 units on a scale
Standard Deviation 25.597
|
|
Nasal Obstruction Symptom Evaluation (NOSE) Score
Change from baseline
|
-25.58 units on a scale
Standard Deviation 28.174
|
-12.22 units on a scale
Standard Deviation 23.874
|
SECONDARY outcome
Timeframe: 90 days, 6 monthsPopulation: Intent-to-treat population consisted of all patients in whom an implant or sham procedure was attempted. There were 2 (2.0%) participants (1 treatment, 1 control) who withdrew from the study prior to Day 90. No imputation of missing values was performed.
To be indicated for RESS, the following criteria had to be met: * Continued to use topical intranasal steroids daily; * Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use * Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and * Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade \>=2 on at least one side)
Outcome measures
| Measure |
Treatment
n=53 Participants
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 Participants
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)
Baseline
|
53 Participants
|
47 Participants
|
|
Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)
Day 90
|
25 Participants
|
36 Participants
|
|
Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)
Month 6
|
36 Participants
|
41 Participants
|
Adverse Events
Treatment
Control
Serious adverse events
| Measure |
Treatment
n=53 participants at risk
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 participants at risk
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/53 • Adverse events were collected from enrollment though month 6
|
2.1%
1/47 • Adverse events were collected from enrollment though month 6
|
Other adverse events
| Measure |
Treatment
n=53 participants at risk
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Mometasone furoate nasal spray (200mcg) once daily
|
Control
n=47 participants at risk
In-office bilateral sham procedure
Mometasone furoate nasal spray (200mcg) once daily
|
|---|---|---|
|
Infections and infestations
Chronic Sinusitits
|
20.8%
11/53 • Adverse events were collected from enrollment though month 6
|
29.8%
14/47 • Adverse events were collected from enrollment though month 6
|
|
Infections and infestations
Upper respiratory tract infection
|
9.4%
5/53 • Adverse events were collected from enrollment though month 6
|
4.3%
2/47 • Adverse events were collected from enrollment though month 6
|
|
Infections and infestations
Acute sinusitis
|
15.1%
8/53 • Adverse events were collected from enrollment though month 6
|
23.4%
11/47 • Adverse events were collected from enrollment though month 6
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
3/53 • Adverse events were collected from enrollment though month 6
|
6.4%
3/47 • Adverse events were collected from enrollment though month 6
|
|
Nervous system disorders
Headache
|
5.7%
3/53 • Adverse events were collected from enrollment though month 6
|
4.3%
2/47 • Adverse events were collected from enrollment though month 6
|
|
Nervous system disorders
Presyncope
|
3.8%
2/53 • Adverse events were collected from enrollment though month 6
|
6.4%
3/47 • Adverse events were collected from enrollment though month 6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.5%
4/53 • Adverse events were collected from enrollment though month 6
|
6.4%
3/47 • Adverse events were collected from enrollment though month 6
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.7%
3/53 • Adverse events were collected from enrollment though month 6
|
6.4%
3/47 • Adverse events were collected from enrollment though month 6
|
Additional Information
James Stambaugh, Vice President of Clinical & Medical Affairs
Intersect ENT, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place