Trial Outcomes & Findings for Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET) (NCT NCT01714687)

NCT ID: NCT01714687

Last Updated: 2024-07-12

Results Overview

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: 24 Week Visit
• Results posted on: 2024-07-12

Participant Flow

Participant milestones

Measure	Balloon Sinus Dilation Subjects treated with balloon sinus dilation	Medical Therapy Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Study STARTED	29	30
Overall Study COMPLETED	26	26
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Balloon Sinus Dilation Subjects treated with balloon sinus dilation	Medical Therapy Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)

Baseline characteristics by cohort

Measure	Balloon Sinus Dilation n=29 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=30 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.	Total n=59 Participants Total of all reporting groups
Age, Continuous	47.1 years STANDARD_DEVIATION 10.0 • n=93 Participants	43.8 years STANDARD_DEVIATION 9.7 • n=4 Participants	45.4 years STANDARD_DEVIATION 9.9 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	19 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	11 Participants n=4 Participants	23 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=93 Participants	27 Participants n=4 Participants	55 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	23 Participants n=93 Participants	28 Participants n=4 Participants	51 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 Week Visit

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum).

The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes.

The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only.

Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).

Higher score indicates greater improvement.

Outcome measures

Measure	Balloon Sinus Dilation n=29 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=30 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
CSS Total Score Change From Baseline to 24 Week Visit	37.3 scores on a scale Standard Deviation 24.4	21.8 scores on a scale Standard Deviation 29.0

SECONDARY outcome

Timeframe: 8, 16, 24, 32, 40, and 48 Weeks

Population: All available date for each follow-up visit is presented.

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("0 Weeks" (minimum) to "7-8 Weeks" (maximum)) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores over 24 and 48 weeks, and average total CSS score over 48 weeks for subjects randomized to BSD versus medical management. Higher score indicates greater improvement.

Outcome measures

Measure	Balloon Sinus Dilation n=29 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=30 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Symptom Sub-score Change at Procedure	3.9 scores on a scale Standard Deviation 19.4	-7.5 scores on a scale Standard Deviation 21.4
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Symptom Sub-score Change at Week 8	39.6 scores on a scale Standard Deviation 33.7	24.1 scores on a scale Standard Deviation 39.6
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Symptom Sub-score Change at Week 16	46.3 scores on a scale Standard Deviation 32.0	30.1 scores on a scale Standard Deviation 38.9
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Symptom Sub-score Change at Week 24	48.7 scores on a scale Standard Deviation 28.7	27.2 scores on a scale Standard Deviation 40.1
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Symptom Sub-score Change at Week 32	45.8 scores on a scale Standard Deviation 33.8	35.4 scores on a scale Standard Deviation 24.7
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Symptom Sub-score Change at Week 40	52.9 scores on a scale Standard Deviation 32.7	29.8 scores on a scale Standard Deviation 22.0
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Symptom Sub-score Change at Week 48	53.8 scores on a scale Standard Deviation 24.6	33.3 scores on a scale Standard Deviation 25.9
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Medication Sub-score Change at Procedure	-1.5 scores on a scale Standard Deviation 17.1	-7.0 scores on a scale Standard Deviation 17.4
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Medication Sub-score Change at Week 8	27.7 scores on a scale Standard Deviation 27.4	12.2 scores on a scale Standard Deviation 22.9
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Medication Sub-score Change at Week 16	25.0 scores on a scale Standard Deviation 27.6	12.2 scores on a scale Standard Deviation 22.5
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Medication Sub-score Change at Week 24	26.0 scores on a scale Standard Deviation 26.6	16.4 scores on a scale Standard Deviation 24.0
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Medication Sub-score Change at Week 32	35.1 scores on a scale Standard Deviation 23.2	26.0 scores on a scale Standard Deviation 32.0
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Medication Sub-score Change at Week 40	37.0 scores on a scale Standard Deviation 24.5	30.9 scores on a scale Standard Deviation 31.1
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks CSS Medication Sub-score Change at Week 48	30.7 scores on a scale Standard Deviation 22.0	27.8 scores on a scale Standard Deviation 30.6
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Total CSS Change Change at Procedure	1.2 scores on a scale Standard Deviation 14.3	-7.2 scores on a scale Standard Deviation 16.1
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Total CSS Change Change at Week 8	33.6 scores on a scale Standard Deviation 27.5	18.2 scores on a scale Standard Deviation 26.4
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Total CSS Change Change at Week 16	35.6 scores on a scale Standard Deviation 24.9	21.1 scores on a scale Standard Deviation 27.1
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Total CSS Change Change at Week 24	37.3 scores on a scale Standard Deviation 24.4	21.8 scores on a scale Standard Deviation 29.0
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Total CSS Change Change at Week 32	40.5 scores on a scale Standard Deviation 22.9	30.7 scores on a scale Standard Deviation 24.3
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Total CSS Change Change at Week 40	44.9 scores on a scale Standard Deviation 22.5	30.4 scores on a scale Standard Deviation 24.0
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Total CSS Change Change at Week 48	42.2 scores on a scale Standard Deviation 17.9	30.6 scores on a scale Standard Deviation 24.2

SECONDARY outcome

Timeframe: 8, 24, and 48 Weeks

Population: All available data for each follow-up visit is presented.

The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values include "Never" (minimum), "Almost Never", "Sometimes", "Almost Always", "Always" (maximum).

RSDI scores range from 0 to 120. Subscores are averaged to calculate a total score. Higher score indicates increased impact of sinus disease.

The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 8, 24 and 48 weeks for subjects randomized to BSD versus medical management.

Lower score indicates greater improvement (decreased impact of sinus disease).

Outcome measures

Measure	Balloon Sinus Dilation n=29 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=30 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Total Change at Procedure	-1.0 scores on a scale Standard Deviation 13.4	2.5 scores on a scale Standard Deviation 9.0
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Total Change at Week 8	-32.9 scores on a scale Standard Deviation 26.8	-17.9 scores on a scale Standard Deviation 30.9
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Total Change at Week 24	-35.6 scores on a scale Standard Deviation 28.2	-18.7 scores on a scale Standard Deviation 27.4
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Total Change at Week 48	-36.9 scores on a scale Standard Deviation 21.1	-17.2 scores on a scale Standard Deviation 14.9
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Physical Sub-score Change at Procedure	-1.8 scores on a scale Standard Deviation 5.7	0.5 scores on a scale Standard Deviation 3.4
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Physical Sub-score Change at Week 8	-14.5 scores on a scale Standard Deviation 11.2	-8.6 scores on a scale Standard Deviation 12.4
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Physical Sub-score Change at Week 24	-15.4 scores on a scale Standard Deviation 10.8	-9.1 scores on a scale Standard Deviation 12.1
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Physical Sub-score Change at Week 48	-15.1 scores on a scale Standard Deviation 9.3	-8.5 scores on a scale Standard Deviation 6.3
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Emotional Sub-score Change at Procedure	1.2 scores on a scale Standard Deviation 5.0	1.8 scores on a scale Standard Deviation 3.8
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Emotional Sub-score Change at Week 8	-8.6 scores on a scale Standard Deviation 8.9	-4.0 scores on a scale Standard Deviation 11.2
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Emotional Sub-score Change at Week 24	-9.8 scores on a scale Standard Deviation 9.2	-3.9 scores on a scale Standard Deviation 9.1
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Emotional Sub-score Change at Week 48	-10.4 scores on a scale Standard Deviation 7.3	-3.7 scores on a scale Standard Deviation 5.6
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Functional Sub-score Change at Procedure	-0.4 scores on a scale Standard Deviation 5.2	0.2 scores on a scale Standard Deviation 3.9
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Functional Sub-score Change at Week 8	-9.8 scores on a scale Standard Deviation 8.2	-5.3 scores on a scale Standard Deviation 9.4
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Functional Sub-score Change at Week 24	-10.4 scores on a scale Standard Deviation 9.6	-5.7 scores on a scale Standard Deviation 7.9
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks RSDI Functional Sub-score Change at Week 48	-11.4 scores on a scale Standard Deviation 7.1	-5.0 scores on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 24 Weeks and 48 Weeks

Population: All available data for each follow-up visit is presented.

Comparison of medication usage at 24 and 48 weeks (days oral antibiotics, oral steroids, topical intranasal steroid sprays, and 'atypical' topical steroids (drops or respules)) for subjects randomized to BSD versus medical management.

Outcome measures

Measure	Balloon Sinus Dilation n=29 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=30 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Medication Usage at 24 and 48 Weeks Oral Antibiotics at 24 Week Visit	0.7 Days Standard Deviation 2.3	2.9 Days Standard Deviation 6.6
Medication Usage at 24 and 48 Weeks Oral Antibiotics at 48 Week Visit	0.5 Days Standard Deviation 2.1	2.0 Days Standard Deviation 3.1
Medication Usage at 24 and 48 Weeks Injected Antibiotics at 24 Week Visit	0.0 Days Standard Deviation 0.0	0.0 Days Standard Deviation 0.0
Medication Usage at 24 and 48 Weeks Injected Antibiotics at 48 Week Visit	0.0 Days Standard Deviation 0.2	0.0 Days Standard Deviation 0.0
Medication Usage at 24 and 48 Weeks Oral Steroids at 24 Week Visit	0.6 Days Standard Deviation 2.8	1.0 Days Standard Deviation 3.1
Medication Usage at 24 and 48 Weeks Oral Steroids at 48 Week Visit	0.7 Days Standard Deviation 2.4	0.0 Days Standard Deviation 0.0
Medication Usage at 24 and 48 Weeks Nasal Steroid Sprays at 24 Week Visit	10.5 Days Standard Deviation 19.0	21.5 Days Standard Deviation 24.0
Medication Usage at 24 and 48 Weeks Nasal Steroid Sprays at 48 Week Visit	10.3 Days Standard Deviation 19.8	24.0 Days Standard Deviation 29.4

SECONDARY outcome

Timeframe: 24 Weeks and 48 Weeks

Population: All available data for each follow-up visit is presented.

Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management.

Outcome measures

Measure	Balloon Sinus Dilation n=29 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=30 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Unscheduled Medical Care Visits Due to Sinusitis Sinus-related visits through 24 weeks	0.2 Medical care visits Standard Deviation 0.8	0.9 Medical care visits Standard Deviation 1.3
Unscheduled Medical Care Visits Due to Sinusitis Sinus-related visits through 48 Weeks	0.2 Medical care visits Standard Deviation 0.9	0.2 Medical care visits Standard Deviation 0.4

SECONDARY outcome

Timeframe: 24 Weeks and 48 Weeks

Population: All available data for each follow-up visit is presented.

Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.

Outcome measures

Measure	Balloon Sinus Dilation n=30 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=29 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Sinus Infections and Sinus Severity - Part 1 Sinus infections thru 24 wks	0.2 Sinus Infections Standard Deviation 0.4	0.9 Sinus Infections Standard Deviation 0.9
Sinus Infections and Sinus Severity - Part 1 Sinus infections thru 48 wks	0.2 Sinus Infections Standard Deviation 0.4	0.4 Sinus Infections Standard Deviation 0.5

SECONDARY outcome

Timeframe: 24 Weeks

Population: All available data for each follow-up visit is presented.

Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.

Outcome measures

Measure	Balloon Sinus Dilation n=30 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=29 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Sinus Infections and Sinus Severity - Part 2 Severity of Sinus Symptoms thru 24 wks · Improved or No Sinus Infection	25 Participants	16 Participants
Sinus Infections and Sinus Severity - Part 2 Severity of Sinus Symptoms thru 24 wks · No Change	1 Participants	10 Participants
Sinus Infections and Sinus Severity - Part 2 Severity of Sinus Symptoms thru 24 wks · Worse	0 Participants	1 Participants
Sinus Infections and Sinus Severity - Part 2 Severity of Sinus Infections thru 24 wks · Improved or No Sinus Infection	25 Participants	18 Participants
Sinus Infections and Sinus Severity - Part 2 Severity of Sinus Infections thru 24 wks · No Change	1 Participants	8 Participants
Sinus Infections and Sinus Severity - Part 2 Severity of Sinus Infections thru 24 wks · Worse	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 24 weeks

Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.

Outcome measures

Measure	Balloon Sinus Dilation n=30 Participants Subjects treated with balloon sinus dilation	Medical Therapy Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Frequency of Second Procedure	18 Participants	—

SECONDARY outcome

Timeframe: 2 week

Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure

Outcome measures

Measure	Balloon Sinus Dilation n=29 Participants Subjects treated with balloon sinus dilation	Medical Therapy n=30 Participants Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Return to Normal Activity	1.8 Days Standard Deviation 1.6	1.3 Days Standard Deviation 1.3

Adverse Events

Balloon Sinus Dilation

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Medical Therapy

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Balloon Sinus Dilation n=29 participants at risk Subjects treated with balloon sinus dilation	Medical Therapy n=30 participants at risk Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Injury, poisoning and procedural complications Facial Pain	3.4% 1/29 • Number of events 1	0.00% 0/30

Other adverse events

Measure	Balloon Sinus Dilation n=29 participants at risk Subjects treated with balloon sinus dilation	Medical Therapy n=30 participants at risk Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Infections and infestations Bronchitis	6.9% 2/29 • Number of events 2	6.7% 2/30 • Number of events 2
Nervous system disorders Headache	3.4% 1/29 • Number of events 1	3.3% 1/30 • Number of events 1
Infections and infestations Sinusitis	6.9% 2/29 • Number of events 3	33.3% 10/30 • Number of events 18
Infections and infestations Upper Respiratory Infection	10.3% 3/29 • Number of events 3	23.3% 7/30 • Number of events 7
Infections and infestations Dental abcess	0.00% 0/29	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Hyposmia	3.4% 1/29 • Number of events 1	0.00% 0/30
Infections and infestations Pneumonia, aspiration	3.4% 1/29 • Number of events 1	0.00% 0/30
Immune system disorders Cervical Lymphadenopathy	3.4% 1/29 • Number of events 1	0.00% 0/30
Ear and labyrinth disorders Eustachian Tube Dysfunction	3.4% 1/29 • Number of events 1	0.00% 0/30
General disorders Pyrexia	3.4% 1/29 • Number of events 1	0.00% 0/30
Reproductive system and breast disorders Infertility	0.00% 0/29	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Gastroesophageal reflux	0.00% 0/29	3.3% 1/30 • Number of events 1
Musculoskeletal and connective tissue disorders Hernia, abdominal	3.4% 1/29 • Number of events 1	0.00% 0/30
Injury, poisoning and procedural complications Nasal Fracture	3.4% 1/29 • Number of events 1	0.00% 0/30
Infections and infestations Mononucleosis	0.00% 0/29	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/29	3.3% 1/30 • Number of events 1
Injury, poisoning and procedural complications Nausea	3.4% 1/29 • Number of events 1	0.00% 0/30
Respiratory, thoracic and mediastinal disorders Nodules of Vocal Code	0.00% 0/29	3.3% 1/30 • Number of events 1
Nervous system disorders Migraine, ocular	3.4% 1/29 • Number of events 1	0.00% 0/30
Skin and subcutaneous tissue disorders Poison Ivy rash	3.4% 1/29 • Number of events 1	0.00% 0/30
Musculoskeletal and connective tissue disorders Arthritis, Psoriatic	0.00% 0/29	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Rhinitis Medicamentosa	3.4% 1/29 • Number of events 1	0.00% 0/30
Gastrointestinal disorders Gastroenteritis	3.4% 1/29 • Number of events 1	0.00% 0/30
Infections and infestations Pharyngitis	6.9% 2/29 • Number of events 3	3.3% 1/30 • Number of events 1
Nervous system disorders Vasovagal Reaction	3.4% 1/29 • Number of events 1	0.00% 0/30

Additional Information

Patricia Chen

Acclarent, Inc

Phone: 949-453-6408

Email: pchen126@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60