Trial Outcomes & Findings for S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps (NCT NCT02291549)

NCT ID: NCT02291549

Last Updated: 2018-08-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 300 participants
• Primary outcome timeframe: Day 30
• Results posted on: 2018-08-15

Participant Flow

Patients were recruited at 40 sites across the US between December 2014 and May 2016, of which 34 sites enrolled at least 1 patient.

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.

Participant milestones

Measure	S8 Sinus Implant 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	Control Bilateral in-office sham procedure Mometasone furoate nasal spray (200 mcg) once daily
Overall Study STARTED	201	99
Overall Study COMPLETED	200	98
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	S8 Sinus Implant 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	Control Bilateral in-office sham procedure Mometasone furoate nasal spray (200 mcg) once daily
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

Baseline characteristics by cohort

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily	Total n=300 Participants Total of all reporting groups
Age, Continuous	50.5 years STANDARD_DEVIATION 12.9 • n=5 Participants	47.9 years STANDARD_DEVIATION 12.4 • n=7 Participants	49.6 years STANDARD_DEVIATION 12.74 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	43 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	56 Participants n=7 Participants	183 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	164 Participants n=5 Participants	80 Participants n=7 Participants	244 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	27 Participants n=5 Participants	13 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: 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.

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.

Outcome measures

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Nasal Obstruction/Congestion Score Baseline	2.36 units on a scale Standard Deviation 0.488	2.35 units on a scale Standard Deviation 0.479
Nasal Obstruction/Congestion Score 30 Day	1.56 units on a scale Standard Deviation 0.743	1.79 units on a scale Standard Deviation 0.674
Nasal Obstruction/Congestion Score Change from baseline	-0.80 units on a scale Standard Deviation 0.729	-0.56 units on a scale Standard Deviation 0.619

PRIMARY outcome

Timeframe: Day 90

Population: 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.

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.

Outcome measures

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Bilateral Polyp Grade Baseline	5.48 units on a scale Standard Deviation 1.132	5.43 units on a scale Standard Deviation 1.009
Bilateral Polyp Grade Day 90	4.91 units on a scale Standard Deviation 1.432	5.26 units on a scale Standard Deviation 1.378
Bilateral Polyp Grade Change from baseline	-0.56 units on a scale Standard Deviation 1.059	-0.15 units on a scale Standard Deviation 0.907

SECONDARY outcome

Timeframe: Day 90

Population: 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.

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.

Outcome measures

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS) Baseline	201 Participants	99 Participants
Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS) Day 90	78 Participants	62 Participants

SECONDARY outcome

Timeframe: Day 90

Population: 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.

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.

Outcome measures

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Ethmoid Sinus Obstruction Baseline	69.2 units on a scale Standard Deviation 19.87	67.0 units on a scale Standard Deviation 18.55
Ethmoid Sinus Obstruction Day 90	57.7 units on a scale Standard Deviation 23.57	64.8 units on a scale Standard Deviation 23.14
Ethmoid Sinus Obstruction Change from baseline	-11.3 units on a scale Standard Deviation 18.11	-1.9 units on a scale Standard Deviation 14.36

SECONDARY outcome

Timeframe: Day 90

Population: 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.

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.

Outcome measures

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Nasal Obstruction/Congestion Score Baseline	2.36 units on a scale Standard Deviation 0.488	2.35 units on a scale Standard Deviation 0.479
Nasal Obstruction/Congestion Score Day 90	1.42 units on a scale Standard Deviation 0.814	1.68 units on a scale Standard Deviation 0.812
Nasal Obstruction/Congestion Score Change from baseline	-0.93 units on a scale Standard Deviation 0.798	-0.69 units on a scale Standard Deviation 0.791

SECONDARY outcome

Timeframe: Day 90

Population: 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.

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.

Outcome measures

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Decreased Sense of Smell Score Baseline	4.1 units on a scale Standard Deviation 1.38	4.1 units on a scale Standard Deviation 1.36
Decreased Sense of Smell Score Day 90	2.9 units on a scale Standard Deviation 1.96	3.4 units on a scale Standard Deviation 1.86
Decreased Sense of Smell Score Change from baseline	-1.20 units on a scale Standard Deviation 1.659	-0.76 units on a scale Standard Deviation 1.599

SECONDARY outcome

Timeframe: Day 90

Population: 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.

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.

Outcome measures

Measure	Treatment n=201 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=99 Participants In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Facial Pain/Pressure Score Baseline	1.9 units on a scale Standard Deviation 1.40	2.2 units on a scale Standard Deviation 1.42
Facial Pain/Pressure Score Day 90	1.1 units on a scale Standard Deviation 1.25	1.2 units on a scale Standard Deviation 1.20
Facial Pain/Pressure Score Change from baseline	-0.77 units on a scale Standard Deviation 1.209	-0.90 units on a scale Standard Deviation 1.269

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=201 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=99 participants at risk In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Respiratory, thoracic and mediastinal disorders Epistaxis	0.50% 1/201 • Number of events 1 • 90 days	0.00% 0/99 • 90 days

Other adverse events

Measure	Treatment n=201 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=99 participants at risk In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Infections and infestations Acute Sinusitis	10.9% 22/201 • 90 days	12.1% 12/99 • 90 days
Infections and infestations Chronic Sinusitis	5.0% 10/201 • 90 days	8.1% 8/99 • 90 days
Infections and infestations Upper respiratory tract infection	5.5% 11/201 • 90 days	4.0% 4/99 • 90 days
Respiratory, thoracic and mediastinal disorders Asthma	5.0% 10/201 • 90 days	4.0% 4/99 • 90 days

Additional Information

James Stambaugh, Vice President of Clinical & Medical Affairs

Intersect ENT, Inc.

Phone: 650-641-2103

Email: jstambaugh@intersectent.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place