RESOLVE: Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

• Sponsor: Intersect ENT (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01732536
• Collaborator: (none)
• Enrollment: 100
• Locations: 19
• Arms: 2
• Actual Duration (Months): 15.9
• Patients Per Site: 5.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.

Condition or Disease	Intervention/Treatment	Phase
Chronic Sinusitis; Nasal Polyps	Drug: S8 Sinus Implant; Procedure: Sham procedure; Drug: Mometasone furoate nasal spray	Phase 2/Phase 3

Detailed Description

RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days, with the majority of drug released within 60 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were removed at Day 60 to allow blinded assessment of bilateral polyp grade at Day 90 by a centralized videoendoscopy review by a panel of 3 independent sinus surgeons.
• Primary Purpose: Treatment
• Official Title: A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction
• Actual Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S8 Sinus Implant In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily	Drug: S8 Sinus Implant; In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses; Other Names: SINUVA (mometasone furoate) sinus implant ; Drug: Mometasone furoate nasal spray; Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90; Other Names: Nasonex Nasal Spray
Sham Comparator: Control In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily	Procedure: Sham procedure; In-office bilateral sham procedure; Drug: Mometasone furoate nasal spray; Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90; Other Names: Nasonex Nasal Spray

Outcome Measures

Primary Outcome Measures

1. Nasal Obstruction/Congestion Score [90 days]

   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

2. Bilateral Polyp Grade [90 days]

   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.

Secondary Outcome Measures

1. Ethmoid Sinus Obstruction [90 days]

   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.

2. Bilateral Polyp Grade [90 days, 6 months]

   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.

3. Nasal Obstruction Symptom Evaluation (NOSE) Score [6 months]

   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.

4. Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS) [90 days, 6 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

Candidates for this study had to meet ALL of the following inclusion criteria:

1. General Inclusion Criteria

2. Patient has provided written informed consent using a form approved by the reviewing IRB.

3. Patient is ≥ 18 years of age.

4. Patient is willing and able to comply with protocol requirements.

5. Patient has a previous confirmed diagnosis of CS defined as inflammation of the mucosa of the paranasal sinuses.

6. Patient has undergone bilateral total ethmoidectomy (must be at least 90 day beyond the date of last sinus surgery).

7. Patient has recurrent bilateral sinus obstruction due to polyposis (Grades 1 through 3 only).

8. Patient must have a Grade 2 polyposis on at least 1 ethmoid side.

9. Patient is able to tolerate the use of Nasonex topical intranasal steroid spray once daily.

10. Patient is indicated for a repeat ESS per the study definition. Patient must have: (i) a minimum symptom burden on the SNOT 22, consisting of a minimum score of 2 on at least 2 of the 5 hallmark symptoms of CS (nasal blockage, post-nasal discharge, thick nasal discharge, facial pain/pressure, and decreased sense of smell); (ii) persistent symptoms of CS despite ongoing treatment with topical intranasal steroid irrigations or sprays at least once daily for at least 2 weeks preceding enrollment; (iii) had treatment with a high-dose form of steroids (e.g., oral, parenteral, injection into polyps) and/or sinus steroid irrigations within the preceding 2 years, or refused such therapy due to intolerance/side effects; (iv) a known history of repeated courses of treatment with aggressive steroid therapy for recurrent sinusitis; and (v) endoscopic evidence of polyp recurrence, scarring, and/or obstructive mucosal edema.

11. Patient is able to tolerate use of topical/local anesthesia and the implant procedure in an office or clinic setting.

12. In the opinion of the physician, treatment with S8 Sinus Implant or sham procedure is technically feasible (able to pass 5-9 mm device into middle meatus) bilaterally.

13. Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.

14. Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study.

Exclusion Criteria

Candidates were excluded if they met ANY of the following criteria:

General Exclusion Criteria

1. Patient had bilateral total ethmoidectomy less than 90 days previously.

2. Patient had Propel implanted postoperatively less than 90 days previously.

3. Patient has presence of adhesions/synechiae Grades 3 or 4.

4. Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.

5. Patient has presence of Grade 4 polyposis.

6. Patient has known history of immune deficiency (e.g., IGG] subclass deficiency or IGA deficiency, HIV).

7. Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).

8. Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD), asthma or other condition.

9. Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate (MF).

10. Patient has known history of resistance or poor response to oral steroids.

11. Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for device delivery (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the nasal passage with severe scarring, polyposis).

12. Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase in purulent discharge, fever, facial pain etc.).

13. Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on prior CT scan, necrotic sinus tissue, etc.).

14. Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 6 month follow-up period.

15. Patient is currently participating in or recently participated in another clinical trial (within the last 30 days).

16. Patient has history of insulin dependent diabetes mellitus.

17. Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure.

18. Patient has completely resected middle turbinate.

19. Patient has known dehiscence of the lamina papyracea.

20. Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox, or measles).

Ocular Exclusion Criteria

1. Patient has history or diagnosis of glaucoma or ocular hypertension (baseline or a known prior ocular exam indicating IOP >21 mm Hg)

2. Patient has closed angle (with or without the presence of peripheral anterior synechiae on gonioscopy)

3. Patient has presence in either eye of: (i) posterior subcapsular cataract, (ii) nuclear sclerosis of Grade +3 or higher; or (iii) cortical cataract of Grade +3 or higher.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Sinus Centers	Atherton	California	United States	94027
2	Cedars-Sinai Medical Center, Sinus Center of Excellence	Los Angeles	California	United States	90048
3	Sacramento Ear, Nose and Throat	Sacramento	California	United States	95815
4	Colorado Ear, Nose, Throat & Allergy	Colorado Springs	Colorado	United States	80909
5	South Florida ENT Associates	Miami	Florida	United States	33176
6	ENT of Georgia	Atlanta	Georgia	United States	30342
7	Northwestern University, Department of Otolaryngology-Head & Neck Surgery	Chicago	Illinois	United States	60611
8	Advanced ENT & Allergy	Louisville	Kentucky	United States	40207
9	Summit Medical Group	Berkeley Heights	New Jersey	United States	07922
10	Albany ENT & Allergy Services	Albany	New York	United States	12206
11	ENT and Allergy Associates	Lake Success	New York	United States	11042
12	Piedmont Ear, Nose & Throat Associates	Winston-Salem	North Carolina	United States	27103
13	Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery	Portland	Oregon	United States	97239
14	Bethlehem ENT Specialty Physicians Associates	Bethlehem	Pennsylvania	United States	18017
15	University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery	Philadelphia	Pennsylvania	United States	19104
16	Medical University of South Carolina	Charleston	South Carolina	United States	29425
17	Intermountain Ear, Nose & Throat Center	Salt Lake City	Utah	United States	84102
18	Eastern Virginia Medical School Department of Otolaryngology	Norfolk	Virginia	United States	23507
19	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53266

Sponsors and Collaborators

• Intersect ENT

Investigators

• Principal Investigator: Keith D Forwith, MD, Advanced ENT and Allergy
• Principal Investigator: Joseph K Han, MD, Eastern Virginia Medical School Department of Otolaryngology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.

• Responsible Party: Intersect ENT
• ClinicalTrials.gov Identifier: NCT01732536
• Other Study ID Numbers: P500-1012
• First Posted: Nov 26, 2012
• Last Update Posted: Jul 20, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Intersect ENT: corticosteroid-eluting sinus implant; chronic rhinosinusitis; mometasone furoate; polyposis
• Additional relevant MeSH terms: Sinusitis; Nasal Polyps; Polyps; Mometasone Furoate

Study Results

Participant Flow

Recruitment Details	Patients were enrolled between January 2013 and November 2013 at 18 clinical sites (12 private, 6 academic).
Pre-assignment Detail	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.

Arm/Group Title	Treatment	Control
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses	In-office bilateral sham procedure
Period Title: Overall Study
STARTED	53	47
COMPLETED	52	46
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Treatment	Control	Total
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily	In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily	Total of all reporting groups
Overall Participants	53	47	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.8 (12.61)	51.6 (13.12)	49.6 (12.93)
Sex: Female, Male (Count of Participants)
Female	24 45.3%	16 34%	40 40%
Male	29 54.7%	31 66%	60 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 7.5%	1 2.1%	5 5%
Not Hispanic or Latino	49 92.5%	46 97.9%	95 95%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 2.1%	1 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 11.3%	2 4.3%	8 8%
White	47 88.7%	44 93.6%	91 91%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	53 100%	47 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Nasal Obstruction/Congestion Score
Description	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
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment	Control
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily	In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Measure Participants	53	47
Baseline	3.62 (1.180)	3.30 (1.159)
Day 90	2.31 (1.422)	2.62 (1.336)
Change from baseline	-1.33 (1.465)	-0.67 (1.446)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1365
	Comments
	Method	ANCOVA
	Comments	Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments	The change from baseline to Day 90 in Nasal Obstruction/Congestion score in the subset of participants with higher polyp burden at baseline (grade 2 or higher polyps on each side; N=67).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0505
	Comments	Based on between group comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects
	Method	ANCOVA
	Comments

2. Primary Outcome

Title	Bilateral Polyp Grade
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment	Control
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily	In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Measure Participants	53	47
Baseline	4.90 (0.918)	4.39 (1.448)
Day 90	4.12 (1.162)	4.00 (1.720)
Change from baseline	-0.76 (0.875)	-0.38 (0.998)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0985
	Comments
	Method	ANCOVA
	Comments	Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments	Bilateral polyp grade change in a subset of 67 patients with higher polyp burden at baseline (grade 2 or higher on each side confirmed by the independent panel)
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0490
	Comments
	Method	ANOVA
	Comments	Based on ANCOVA model with baseline as a covariate, site and treatment as fixed effect

3. Secondary Outcome

Title	Ethmoid Sinus Obstruction
Description	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.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	S8 Sinus Implant	Control
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily	In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Measure Participants	53	47
Baseline	70.59 (18.201)	62.74 (25.673)
Day 90	53.54 (20.140)	57.17 (28.516)
Change from baseline	-17.05 (19.361)	-5.57 (18.279)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0099
	Comments
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Bilateral Polyp Grade
Description	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.
Time Frame	90 days, 6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	S8 Sinus Implant	Control
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily	In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Measure Participants	53	47
Baseline	4.68 (0.956)	4.32 (1.105)
90 days	3.65 (1.655)	4.24 (1.667)
Change from baseline to 90 days	-1.04 (1.680)	-0.09 (1.203)
Month 6	3.96 (1.587)	4.36 (1.708)
Change from baseline to 6 months	-0.71 (1.527)	0.02 (1.158)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0162
	Comments	P-value for change from baseline to 90 days not adjusted for multiplicity
	Method	ANCOVA
	Comments	ANCOVA model with baseline as a covariate and site and treatment as fixed effects

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0175
	Comments	P-value for change from baseline to 6 months not adjusted for multiplicity
	Method	ANCOVA
	Comments	ANCOVA model with baseline as a covariate and site and treatment as fixed effects

5. Secondary Outcome

Title	Nasal Obstruction Symptom Evaluation (NOSE) Score
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	S8 Sinus Implant	Control
Arm/Group Description	Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg) S8 Sinus Implant: Bilateral in-office placement of S8 sinus implant with 1350 mcg of mometasone furoate and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily	Bilateral in-office sham procedure in the ethmoid sinuses and continued Nasonex (mometasone furoate nasal spray, 200 mcg) Sham procedure: Bilateral in-office sham procedure and continued steroid nasal spray (mometasone furoate, 200 mcg) once daily
Measure Participants	53	47
Baseline	66.79 (26.658)	63.19 (23.943)
Month 6	41.83 (24.395)	50.67 (25.597)
Change from baseline	-25.58 (28.174)	-12.22 (23.874)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0209
	Comments	P-value not adjusted for multiplicity.
	Method	ANCOVA
	Comments	Based on between arm comparison using ANCOVA model with baseline as a covariate and site and treatment as fixed effects

6. Secondary Outcome

Title	Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)
Description	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)
Time Frame	90 days, 6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	S8 Sinus Implant	Control
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily	In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Measure Participants	53	47
Baseline	53 100%	47 100%
Day 90	25 47.2%	36 76.6%
Month 6	36 67.9%	41 87.2%

Adverse Events

Time Frame	Adverse events were collected from enrollment though month 6
Arm/Group Title	Treatment		Control
Arm/Group Description	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily		In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
All Cause Mortality
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/47 (0%)
Serious Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		1/47 (2.1%)
Psychiatric disorders
Suicidal ideation	0/53 (0%)		1/47 (2.1%)
Other (Not Including Serious) Adverse Events
	Treatment		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	38/53 (71.7%)		36/47 (76.6%)
Infections and infestations
Chronic Sinusitits	11/53 (20.8%)		14/47 (29.8%)
Upper respiratory tract infection	5/53 (9.4%)		2/47 (4.3%)
Acute sinusitis	8/53 (15.1%)		11/47 (23.4%)
Nasopharyngitis	3/53 (5.7%)		3/47 (6.4%)
Nervous system disorders
Headache	3/53 (5.7%)		2/47 (4.3%)
Presyncope	2/53 (3.8%)		3/47 (6.4%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	4/53 (7.5%)		3/47 (6.4%)
Asthma	3/53 (5.7%)		3/47 (6.4%)

Limitations/Caveats

Absence of defined medical regimen prior to enrollment Investigators grading polyps and assessing indication for RESS were not blinded Indication for RESS at baseline allowed for 1 sinus side to have polyp grade >=1

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.