Recurrent Acute Rhinosinusitis
Conditions
Brief summary
This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.
Interventions
DEVICEballoon sinus dilation
OTHERmedical therapy
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 19 years of age or greater * diagnosis of recurrent acute rhinosinusitis * suitable candidate for office-based procedure * willing and able to read and sign informed consent and remain compliant with protocol and study procedures * able to read and understand English
Exclusion criteria
* diagnosis of chronic rhinosinusitis * prior sinus surgery * physician determined need for ancillary procedures * known immune deficiency, ciliary dysfunction and/or autoimmune disease * clinically significant illness that may interfere with evaluation of the study * participation in clinical studies 6 months prior to study participation * pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSS Total Score Change From Baseline to 24 Week Visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | 8, 24, and 48 Weeks | 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). |
| Medication Usage at 24 and 48 Weeks | 24 Weeks and 48 Weeks | 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. |
| Unscheduled Medical Care Visits Due to Sinusitis | 24 Weeks and 48 Weeks | Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management. |
| CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | 8, 16, 24, 32, 40, and 48 Weeks | 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. |
| Sinus Infections and Sinus Severity - Part 2 | 24 Weeks | Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management. |
| Frequency of Second Procedure | Up to 24 weeks | Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure. |
| Return to Normal Activity | 2 week | Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure |
| Sinus Infections and Sinus Severity - Part 1 | 24 Weeks and 48 Weeks | Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Balloon Sinus Dilation Subjects treated with balloon sinus dilation | 29 |
| Medical Therapy Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement. | 30 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Medical Therapy | Total | Balloon Sinus Dilation |
|---|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 9.7 | 45.4 years STANDARD_DEVIATION 9.9 | 47.1 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 55 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 51 Participants | 23 Participants |
| Sex: Female, Male Female | 19 Participants | 36 Participants | 17 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 |
| other Total, other adverse events | 17 / 29 | 18 / 30 |
| serious Total, serious adverse events | 1 / 29 | 0 / 30 |
Outcome results
Primary
CSS Total Score Change From Baseline to 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.
Time frame: 24 Week Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | CSS Total Score Change From Baseline to 24 Week Visit | 37.3 scores on a scale | Standard Deviation 24.4 |
| Medical Therapy | CSS Total Score Change From Baseline to 24 Week Visit | 21.8 scores on a scale | Standard Deviation 29 |
Secondary
CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks
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.
Time frame: 8, 16, 24, 32, 40, and 48 Weeks
Population: All available date for each follow-up visit is presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Symptom Sub-score Change at Week 16 | 30.1 scores on a scale | Standard Deviation 38.9 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Medication Sub-score Change at Week 48 | 27.8 scores on a scale | Standard Deviation 30.6 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Medication Sub-score Change at Week 24 | 16.4 scores on a scale | Standard Deviation 24 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | Total CSS Change Change at Procedure | -7.2 scores on a scale | Standard Deviation 16.1 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Symptom Sub-score Change at Week 24 | 27.2 scores on a scale | Standard Deviation 40.1 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | Total CSS Change Change at Week 8 | 18.2 scores on a scale | Standard Deviation 26.4 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Medication Sub-score Change at Week 8 | 12.2 scores on a scale | Standard Deviation 22.9 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | Total CSS Change Change at Week 16 | 21.1 scores on a scale | Standard Deviation 27.1 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Symptom Sub-score Change at Week 32 | 35.4 scores on a scale | Standard Deviation 24.7 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | Total CSS Change Change at Week 24 | 21.8 scores on a scale | Standard Deviation 29 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Medication Sub-score Change at Week 40 | 30.9 scores on a scale | Standard Deviation 31.1 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | Total CSS Change Change at Week 32 | 30.7 scores on a scale | Standard Deviation 24.3 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Symptom Sub-score Change at Week 40 | 29.8 scores on a scale | Standard Deviation 22 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | Total CSS Change Change at Week 40 | 30.4 scores on a scale | Standard Deviation 24 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Medication Sub-score Change at Week 16 | 12.2 scores on a scale | Standard Deviation 22.5 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | Total CSS Change Change at Week 48 | 30.6 scores on a scale | Standard Deviation 24.2 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Symptom Sub-score Change at Week 48 | 33.3 scores on a scale | Standard Deviation 25.9 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Symptom Sub-score Change at Procedure | -7.5 scores on a scale | Standard Deviation 21.4 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Medication Sub-score Change at Week 32 | 26.0 scores on a scale | Standard Deviation 32 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Symptom Sub-score Change at Week 8 | 24.1 scores on a scale | Standard Deviation 39.6 |
| Medical Therapy | CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks | CSS Medication Sub-score Change at Procedure | -7.0 scores on a scale | Standard Deviation 17.4 |
Secondary
Frequency of Second Procedure
Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.
Time frame: Up to 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Balloon Sinus Dilation | Frequency of Second Procedure | 18 Participants |
Secondary
Medication Usage at 24 and 48 Weeks
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.
Time frame: 24 Weeks and 48 Weeks
Population: All available data for each follow-up visit is presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Oral Antibiotics at 24 Week Visit | 0.7 Days | Standard Deviation 2.3 |
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Oral Antibiotics at 48 Week Visit | 0.5 Days | Standard Deviation 2.1 |
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Injected Antibiotics at 24 Week Visit | 0.0 Days | Standard Deviation 0 |
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Injected Antibiotics at 48 Week Visit | 0.0 Days | Standard Deviation 0.2 |
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Oral Steroids at 24 Week Visit | 0.6 Days | Standard Deviation 2.8 |
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Oral Steroids at 48 Week Visit | 0.7 Days | Standard Deviation 2.4 |
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Nasal Steroid Sprays at 24 Week Visit | 10.5 Days | Standard Deviation 19 |
| Balloon Sinus Dilation | Medication Usage at 24 and 48 Weeks | Nasal Steroid Sprays at 48 Week Visit | 10.3 Days | Standard Deviation 19.8 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Nasal Steroid Sprays at 48 Week Visit | 24.0 Days | Standard Deviation 29.4 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Oral Antibiotics at 24 Week Visit | 2.9 Days | Standard Deviation 6.6 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Oral Steroids at 24 Week Visit | 1.0 Days | Standard Deviation 3.1 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Oral Antibiotics at 48 Week Visit | 2.0 Days | Standard Deviation 3.1 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Nasal Steroid Sprays at 24 Week Visit | 21.5 Days | Standard Deviation 24 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Injected Antibiotics at 24 Week Visit | 0.0 Days | Standard Deviation 0 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Oral Steroids at 48 Week Visit | 0.0 Days | Standard Deviation 0 |
| Medical Therapy | Medication Usage at 24 and 48 Weeks | Injected Antibiotics at 48 Week Visit | 0.0 Days | Standard Deviation 0 |
Secondary
Return to Normal Activity
Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure
Time frame: 2 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Balloon Sinus Dilation | Return to Normal Activity | 1.8 Days | Standard Deviation 1.6 |
| Medical Therapy | Return to Normal Activity | 1.3 Days | Standard Deviation 1.3 |
Secondary
RSDI Total and Sub-score Changes From Baseline Over 48 Weeks
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).
Time frame: 8, 24, and 48 Weeks
Population: All available data for each follow-up visit is presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Balloon Sinus Dilation | 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 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Functional Sub-score Change at Week 48 | -5.0 scores on a scale | Standard Deviation 4.9 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Total Change at Procedure | 2.5 scores on a scale | Standard Deviation 9 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Emotional Sub-score Change at Procedure | 1.8 scores on a scale | Standard Deviation 3.8 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Total Change at Week 8 | -17.9 scores on a scale | Standard Deviation 30.9 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Functional Sub-score Change at Procedure | 0.2 scores on a scale | Standard Deviation 3.9 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Total Change at Week 24 | -18.7 scores on a scale | Standard Deviation 27.4 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Emotional Sub-score Change at Week 8 | -4.0 scores on a scale | Standard Deviation 11.2 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Total Change at Week 48 | -17.2 scores on a scale | Standard Deviation 14.9 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Functional Sub-score Change at Week 24 | -5.7 scores on a scale | Standard Deviation 7.9 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Physical Sub-score Change at Procedure | 0.5 scores on a scale | Standard Deviation 3.4 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Emotional Sub-score Change at Week 24 | -3.9 scores on a scale | Standard Deviation 9.1 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Physical Sub-score Change at Week 8 | -8.6 scores on a scale | Standard Deviation 12.4 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Functional Sub-score Change at Week 8 | -5.3 scores on a scale | Standard Deviation 9.4 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Physical Sub-score Change at Week 24 | -9.1 scores on a scale | Standard Deviation 12.1 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Emotional Sub-score Change at Week 48 | -3.7 scores on a scale | Standard Deviation 5.6 |
| Medical Therapy | RSDI Total and Sub-score Changes From Baseline Over 48 Weeks | RSDI Physical Sub-score Change at Week 48 | -8.5 scores on a scale | Standard Deviation 6.3 |
Secondary
Sinus Infections and Sinus Severity - Part 1
Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.
Time frame: 24 Weeks and 48 Weeks
Population: All available data for each follow-up visit is presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 1 | Sinus infections thru 24 wks | 0.2 Sinus Infections | Standard Deviation 0.4 |
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 1 | Sinus infections thru 48 wks | 0.2 Sinus Infections | Standard Deviation 0.4 |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 1 | Sinus infections thru 24 wks | 0.9 Sinus Infections | Standard Deviation 0.9 |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 1 | Sinus infections thru 48 wks | 0.4 Sinus Infections | Standard Deviation 0.5 |
Secondary
Sinus Infections and Sinus Severity - Part 2
Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.
Time frame: 24 Weeks
Population: All available data for each follow-up visit is presented.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Symptoms thru 24 wks | Improved or No Sinus Infection | 25 Participants |
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Symptoms thru 24 wks | No Change | 1 Participants |
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Symptoms thru 24 wks | Worse | 0 Participants |
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Infections thru 24 wks | Improved or No Sinus Infection | 25 Participants |
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Infections thru 24 wks | No Change | 1 Participants |
| Balloon Sinus Dilation | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Infections thru 24 wks | Worse | 0 Participants |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Infections thru 24 wks | No Change | 8 Participants |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Symptoms thru 24 wks | Improved or No Sinus Infection | 16 Participants |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Infections thru 24 wks | Improved or No Sinus Infection | 18 Participants |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Symptoms thru 24 wks | No Change | 10 Participants |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Infections thru 24 wks | Worse | 1 Participants |
| Medical Therapy | Sinus Infections and Sinus Severity - Part 2 | Severity of Sinus Symptoms thru 24 wks | Worse | 1 Participants |
Secondary
Unscheduled Medical Care Visits Due to Sinusitis
Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management.
Time frame: 24 Weeks and 48 Weeks
Population: All available data for each follow-up visit is presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Balloon Sinus Dilation | Unscheduled Medical Care Visits Due to Sinusitis | Sinus-related visits through 24 weeks | 0.2 Medical care visits | Standard Deviation 0.8 |
| Balloon Sinus Dilation | Unscheduled Medical Care Visits Due to Sinusitis | Sinus-related visits through 48 Weeks | 0.2 Medical care visits | Standard Deviation 0.9 |
| Medical Therapy | Unscheduled Medical Care Visits Due to Sinusitis | Sinus-related visits through 24 weeks | 0.9 Medical care visits | Standard Deviation 1.3 |
| Medical Therapy | Unscheduled Medical Care Visits Due to Sinusitis | Sinus-related visits through 48 Weeks | 0.2 Medical care visits | Standard Deviation 0.4 |