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S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps (RESOLVE_II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291549
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : July 9, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Sinusitis
Nasal Polyposis
Interventions Drug: S8 Sinus Implant
Drug: Mometasone furoate nasal spray
Procedure: Sham
Enrollment 300
Recruitment Details Patients were recruited at 40 sites across the US between December 2014 and May 2016, of which 34 sites enrolled at least 1 patient.
Pre-assignment Details Patients were considered enrolled into the study after signing the ICF and entered a 2-week screening period. A video-recorded screening endoscopy and symptom scoring, using a daily diary, were required to confirm patient eligibility. Video-endoscopies were assessed by an independent reviewer in order to confirm bilateral polyposis.
Arm/Group Title S8 Sinus Implant Control
Hide Arm/Group Description

Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray (200 mcg) once daily

Bilateral in-office sham procedure

Mometasone furoate nasal spray (200 mcg) once daily

Period Title: Overall Study
Started 201 99
Completed 200 98
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
Arm/Group Title Treatment Control Total
Hide 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 Number of Baseline Participants 201 99 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 99 participants 300 participants
50.5  (12.9) 47.9  (12.4) 49.6  (12.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 99 participants 300 participants
Female
74
  36.8%
43
  43.4%
117
  39.0%
Male
127
  63.2%
56
  56.6%
183
  61.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 201 participants 99 participants 300 participants
White
164
  81.6%
80
  80.8%
244
  81.3%
Black
27
  13.4%
13
  13.1%
40
  13.3%
Asian
4
   2.0%
4
   4.0%
8
   2.7%
Other
6
   3.0%
2
   2.0%
8
   2.7%
1.Primary Outcome
Title Nasal Obstruction/Congestion Score
Hide Description Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Scoring for >=4 days in 7 days before the baseline and Day 30 visits was required. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 4 (1.3%) participants (2 treatment, 2 control) with missing values at Day 30. No imputation of missing values was performed.
Arm/Group Title Treatment Control
Hide 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

Overall Number of Participants Analyzed 201 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 200 participants 99 participants
2.36  (0.488) 2.35  (0.479)
30 Day Number Analyzed 199 participants 97 participants
1.56  (0.743) 1.79  (0.674)
Change from baseline Number Analyzed 199 participants 97 participants
-0.80  (0.729) -0.56  (0.619)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the Nasal Obstruction/Congestion score compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0074
Comments The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparison.
Method ANCOVA
Comments Where appropriate, confidence intervals of the difference were constructed using the estimate of the least-squares means
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.39 to -0.06
Estimation Comments [Not Specified]
2.Primary Outcome
Title Bilateral Polyp Grade
Hide Description Polyp grade was determined by an independent panel of 3 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 indicated reduction (improvement) in bilateral polyp grade.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.
Arm/Group Title Treatment Control
Hide Arm/Group Description:

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray (200 mcg) once daily

In-office bilateral sham procedure

Mometasone furoate nasal spray (200 mcg) once daily

Overall Number of Participants Analyzed 201 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 201 participants 99 participants
5.48  (1.132) 5.43  (1.009)
Day 90 Number Analyzed 195 participants 97 participants
4.91  (1.432) 5.26  (1.378)
Change from baseline Number Analyzed 195 participants 97 participants
-0.56  (1.059) -0.15  (0.907)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments The between treatment group difference was estimated using the ANCOVA model with site and treatment group as fixed effects. The primary efficacy hypothesis was that the use of the S8 Sinus Implant would reduce the bilateral polyp grade compared to the control group. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0073
Comments The 2-sided alpha was 0.05. P-value was not adjusted for multiple comparisons.
Method ANCOVA
Comments ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.60 to -0.09
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)
Hide Description Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade >= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population, consisting of all patients in whom an implant or sham procedure was attempted. 2 participants did not complete Day 90 visit. No imputation of missing values was performed.
Arm/Group Title Treatment Control
Hide 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

Overall Number of Participants Analyzed 201 99
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 201 participants 99 participants
201
 100.0%
99
 100.0%
Day 90 Number Analyzed 200 participants 98 participants
78
  39.0%
62
  63.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments Test: H0: OR = 1 vs. OR ≠ 1 by Cochrane-Mantel-Haenszel test
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.
Method Cochran-Mantel-Haenszel
Comments Adjusted p-value is presented.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.69
Confidence Interval (2-Sided) 95%
1.63 to 4.44
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Ethmoid Sinus Obstruction
Hide Description Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 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 indicated reduction (improvement) in ethmoid sinus obstruction.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.
Arm/Group Title Treatment Control
Hide Arm/Group Description:

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray (200 mcg) once daily

In-office bilateral sham procedure

Mometasone furoate nasal spray (200 mcg) once daily

Overall Number of Participants Analyzed 201 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 201 participants 99 participants
69.2  (19.87) 67.0  (18.55)
Day 90 Number Analyzed 195 participants 97 participants
57.7  (23.57) 64.8  (23.14)
Change from baseline Number Analyzed 201 participants 99 participants
-11.3  (18.11) -1.9  (14.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups.The null hypothesis was H0: β1 = 0 and the alternative hypothesis was H1: β1 ≠ 0. Although the alternative hypothesis was specified as 2-sided, only a statistically significant, negative estimate of β1 constituted evidence of effectiveness. The 2-sided alpha for this test was 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.
Method ANCOVA
Comments Adjusted p-value is presented.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.96
Confidence Interval (2-Sided) 95%
-12.10 to -3.83
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Nasal Obstruction/Congestion Score
Hide Description Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Scoring for >=4 of 7 days immediately preceding the baseline and Day 90 visits was required. There were 34 (11.3%) participants with missing scores: 23 treatment and 10 control at Day 90 and 1 (treatment) at baseline. No imputation of missing values was performed.
Arm/Group Title Treatment Control
Hide 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

Overall Number of Participants Analyzed 201 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 200 participants 99 participants
2.36  (0.488) 2.35  (0.479)
Day 90 Number Analyzed 178 participants 89 participants
1.42  (0.814) 1.68  (0.812)
Change from baseline Number Analyzed 177 participants 89 participants
-0.93  (0.798) -0.69  (0.791)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and the alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0248
Comments P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.
Method ANCOVA
Comments Adjusted p-value is presented.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.48 to -0.07
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Decreased Sense of Smell Score
Hide Description Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.
Arm/Group Title Treatment Control
Hide 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

Overall Number of Participants Analyzed 201 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 201 participants 99 participants
4.1  (1.38) 4.1  (1.36)
Day 90 Number Analyzed 198 participants 97 participants
2.9  (1.96) 3.4  (1.86)
Change from baseline Number Analyzed 198 participants 97 participants
-1.20  (1.659) -0.76  (1.599)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0470
Comments P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.
Method ANCOVA
Comments The adjusted p-value is presentenced.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.46
Confidence Interval (2-Sided) 95%
-0.85 to -0.06
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Facial Pain/Pressure Score
Hide Description Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms.
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values: 3 at baseline (1 treatment, 1 control)) and 2 at Day 90 (1 treatment, 1 control) No imputation of missing values was performed.
Arm/Group Title Treatment Control
Hide 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

Overall Number of Participants Analyzed 201 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 200 participants 98 participants
1.9  (1.40) 2.2  (1.42)
Day 90 Number Analyzed 198 participants 97 participants
1.1  (1.25) 1.2  (1.20)
Change from baseline Number Analyzed 197 participants 96 participants
-0.77  (1.209) -0.90  (1.269)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment, Control
Comments ANCOVA model with site and treatment group as fixed effects and contrasts constructed to estimate the difference between treatment groups. The null hypothesis was H0: β1=0 and alternative hypothesis was H1: β1 ≠ 0. Only a statistically significant, negative estimate of β1 was to constitute evidence of effectiveness.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9130
Comments P-value adjusted for multiplicity using the Holm’s step-down procedure at a 2-sided significance level of 0.05.
Method ANCOVA
Comments Adjusted p-value is presented.
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Control
Hide 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 (%) Affected / at Risk (%)
Total   0/201 (0.00%)      0/99 (0.00%)    
Hide Serious Adverse Events
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/201 (0.50%)      0/99 (0.00%)    
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1 [1]  1/201 (0.50%)  1 0/99 (0.00%)  0
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
SAE that was judged to be related to the S8 Sinus Implant
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/201 (26.37%)      28/99 (28.28%)    
Infections and infestations     
Acute Sinusitis  1  22/201 (10.95%)  12/99 (12.12%) 
Chronic Sinusitis  1  10/201 (4.98%)  8/99 (8.08%) 
Upper respiratory tract infection  1  11/201 (5.47%)  4/99 (4.04%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  10/201 (4.98%)  4/99 (4.04%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
  1. The absence of a defined medical regimen prior to enrollment.
  2. The clinical investigators performing assessment of indication for RESS at Day 90 were unblinded.
  3. The relatively short duration of the trial (90 days).
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Stambaugh, Vice President of Clinical & Medical Affairs
Organization: Intersect ENT, Inc.
Phone: 650-641-2103
EMail: jstambaugh@intersectent.com
Layout table for additonal information
Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02291549    
Other Study ID Numbers: P500-1113
First Submitted: November 11, 2014
First Posted: November 14, 2014
Results First Submitted: April 16, 2018
Results First Posted: July 9, 2018
Last Update Posted: August 15, 2018