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

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: NCT01714687
Recruitment Status : Completed
First Posted : October 26, 2012
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Acclarent

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Recurrent Acute Rhinosinusitis
Interventions Device: balloon sinus dilation
Other: medical therapy
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description Subjects treated with balloon sinus dilation Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Period Title: Overall Study
Started 29 30
Completed 26 26
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             2             4
Arm/Group Title Balloon Sinus Dilation Medical Therapy Total
Hide Arm/Group Description Subjects treated with balloon sinus dilation Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement. Total of all reporting groups
Overall Number of Baseline Participants 29 30 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 59 participants
47.1  (10.0) 43.8  (9.7) 45.4  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
Female
17
  58.6%
19
  63.3%
36
  61.0%
Male
12
  41.4%
11
  36.7%
23
  39.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
Hispanic or Latino
1
   3.4%
3
  10.0%
4
   6.8%
Not Hispanic or Latino
28
  96.6%
27
  90.0%
55
  93.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.4%
0
   0.0%
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  17.2%
1
   3.3%
6
  10.2%
White
23
  79.3%
28
  93.3%
51
  86.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.3%
1
   1.7%
1.Primary Outcome
Title CSS Total Score Change From Baseline to 24 Week Visit
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description:
Subjects treated with balloon sinus dilation
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
37.3  (24.4) 21.8  (29.0)
2.Secondary Outcome
Title CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All available date for each follow-up visit is presented.
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description:
Subjects treated with balloon sinus dilation
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
CSS Symptom Sub-score Change at Procedure Number Analyzed 28 participants 30 participants
3.9  (19.4) -7.5  (21.4)
CSS Symptom Sub-score Change at Week 8 Number Analyzed 28 participants 28 participants
39.6  (33.7) 24.1  (39.6)
CSS Symptom Sub-score Change at Week 16 Number Analyzed 27 participants 28 participants
46.3  (32.0) 30.1  (38.9)
CSS Symptom Sub-score Change at Week 24 Number Analyzed 26 participants 27 participants
48.7  (28.7) 27.2  (40.1)
CSS Symptom Sub-score Change at Week 32 Number Analyzed 24 participants 8 participants
45.8  (33.8) 35.4  (24.7)
CSS Symptom Sub-score Change at Week 40 Number Analyzed 23 participants 7 participants
52.9  (32.7) 29.8  (22.0)
CSS Symptom Sub-score Change at Week 48 Number Analyzed 22 participants 6 participants
53.8  (24.6) 33.3  (25.9)
CSS Medication Sub-score Change at Procedure Number Analyzed 28 participants 30 participants
-1.5  (17.1) -7.0  (17.4)
CSS Medication Sub-score Change at Week 8 Number Analyzed 28 participants 28 participants
27.7  (27.4) 12.2  (22.9)
CSS Medication Sub-score Change at Week 16 Number Analyzed 27 participants 28 participants
25.0  (27.6) 12.2  (22.5)
CSS Medication Sub-score Change at Week 24 Number Analyzed 26 participants 27 participants
26.0  (26.6) 16.4  (24.0)
CSS Medication Sub-score Change at Week 32 Number Analyzed 24 participants 8 participants
35.1  (23.2) 26.0  (32.0)
CSS Medication Sub-score Change at Week 40 Number Analyzed 23 participants 7 participants
37.0  (24.5) 30.9  (31.1)
CSS Medication Sub-score Change at Week 48 Number Analyzed 22 participants 6 participants
30.7  (22.0) 27.8  (30.6)
Total CSS Change Change at Procedure Number Analyzed 28 participants 30 participants
1.2  (14.3) -7.2  (16.1)
Total CSS Change Change at Week 8 Number Analyzed 28 participants 28 participants
33.6  (27.5) 18.2  (26.4)
Total CSS Change Change at Week 16 Number Analyzed 27 participants 28 participants
35.6  (24.9) 21.1  (27.1)
Total CSS Change Change at Week 24 Number Analyzed 26 participants 27 participants
37.3  (24.4) 21.8  (29.0)
Total CSS Change Change at Week 32 Number Analyzed 24 participants 8 participants
40.5  (22.9) 30.7  (24.3)
Total CSS Change Change at Week 40 Number Analyzed 23 participants 7 participants
44.9  (22.5) 30.4  (24.0)
Total CSS Change Change at Week 48 Number Analyzed 22 participants 6 participants
42.2  (17.9) 30.6  (24.2)
3.Secondary Outcome
Title RSDI Total and Sub-score Changes From Baseline Over 48 Weeks
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
All available data for each follow-up visit is presented.
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description:
Subjects treated with balloon sinus dilation
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: scores on a scale
RSDI Total Change at Procedure Number Analyzed 28 participants 30 participants
-1.0  (13.4) 2.5  (9.0)
RSDI Total Change at Week 8 Number Analyzed 28 participants 28 participants
-32.9  (26.8) -17.9  (30.9)
RSDI Total Change at Week 24 Number Analyzed 26 participants 27 participants
-35.6  (28.2) -18.7  (27.4)
RSDI Total Change at Week 48 Number Analyzed 22 participants 6 participants
-36.9  (21.1) -17.2  (14.9)
RSDI Physical Sub-score Change at Procedure Number Analyzed 28 participants 30 participants
-1.8  (5.7) 0.5  (3.4)
RSDI Physical Sub-score Change at Week 8 Number Analyzed 28 participants 28 participants
-14.5  (11.2) -8.6  (12.4)
RSDI Physical Sub-score Change at Week 24 Number Analyzed 26 participants 27 participants
-15.4  (10.8) -9.1  (12.1)
RSDI Physical Sub-score Change at Week 48 Number Analyzed 22 participants 6 participants
-15.1  (9.3) -8.5  (6.3)
RSDI Emotional Sub-score Change at Procedure Number Analyzed 28 participants 30 participants
1.2  (5.0) 1.8  (3.8)
RSDI Emotional Sub-score Change at Week 8 Number Analyzed 28 participants 28 participants
-8.6  (8.9) -4.0  (11.2)
RSDI Emotional Sub-score Change at Week 24 Number Analyzed 26 participants 27 participants
-9.8  (9.2) -3.9  (9.1)
RSDI Emotional Sub-score Change at Week 48 Number Analyzed 22 participants 6 participants
-10.4  (7.3) -3.7  (5.6)
RSDI Functional Sub-score Change at Procedure Number Analyzed 28 participants 30 participants
-0.4  (5.2) 0.2  (3.9)
RSDI Functional Sub-score Change at Week 8 Number Analyzed 28 participants 28 participants
-9.8  (8.2) -5.3  (9.4)
RSDI Functional Sub-score Change at Week 24 Number Analyzed 26 participants 27 participants
-10.4  (9.6) -5.7  (7.9)
RSDI Functional Sub-score Change at Week 48 Number Analyzed 22 participants 6 participants
-11.4  (7.1) -5.0  (4.9)
4.Secondary Outcome
Title Medication Usage at 24 and 48 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All available data for each follow-up visit is presented.
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description:
Subjects treated with balloon sinus dilation
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: Days
Oral Antibiotics at 24 Week Visit Number Analyzed 26 participants 27 participants
0.7  (2.3) 2.9  (6.6)
Oral Antibiotics at 48 Week Visit Number Analyzed 22 participants 5 participants
0.5  (2.1) 2.0  (3.1)
Injected Antibiotics at 24 Week Visit Number Analyzed 26 participants 27 participants
0.0  (0.0) 0.0  (0.0)
Injected Antibiotics at 48 Week Visit Number Analyzed 22 participants 5 participants
0.0  (0.2) 0.0  (0.0)
Oral Steroids at 24 Week Visit Number Analyzed 26 participants 27 participants
0.6  (2.8) 1.0  (3.1)
Oral Steroids at 48 Week Visit Number Analyzed 22 participants 5 participants
0.7  (2.4) 0.0  (0.0)
Nasal Steroid Sprays at 24 Week Visit Number Analyzed 26 participants 27 participants
10.5  (19.0) 21.5  (24.0)
Nasal Steroid Sprays at 48 Week Visit Number Analyzed 21 participants 5 participants
10.3  (19.8) 24.0  (29.4)
5.Secondary Outcome
Title Unscheduled Medical Care Visits Due to Sinusitis
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All available data for each follow-up visit is presented.
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description:
Subjects treated with balloon sinus dilation
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: Medical care visits
Sinus-related visits through 24 weeks Number Analyzed 26 participants 27 participants
0.2  (0.8) 0.9  (1.3)
Sinus-related visits through 48 Weeks Number Analyzed 22 participants 5 participants
0.2  (0.9) 0.2  (0.4)
6.Secondary Outcome
Title Sinus Infections and Sinus Severity - Part 1
Hide Description Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.
Time Frame 24 Weeks and 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All available data for each follow-up visit is presented.
Arm/Group Title Medical Therapy Balloon Sinus Dilation
Hide Arm/Group Description:
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Subjects treated with balloon sinus dilation
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Sinus Infections
Sinus infections thru 24 wks Number Analyzed 26 participants 27 participants
0.2  (0.4) 0.9  (0.9)
Sinus infections thru 48 wks Number Analyzed 22 participants 5 participants
0.2  (0.4) 0.4  (0.5)
7.Secondary Outcome
Title Sinus Infections and Sinus Severity - Part 2
Hide Description Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All available data for each follow-up visit is presented.
Arm/Group Title Medical Therapy Balloon Sinus Dilation
Hide Arm/Group Description:
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Subjects treated with balloon sinus dilation
Overall Number of Participants Analyzed 30 29
Measure Type: Count of Participants
Unit of Measure: Participants
Severity of Sinus Symptoms thru 24 wks Number Analyzed 26 participants 27 participants
Improved or No Sinus Infection
25
  96.2%
16
  59.3%
No Change
1
   3.8%
10
  37.0%
Worse
0
   0.0%
1
   3.7%
Severity of Sinus Infections thru 24 wks Number Analyzed 26 participants 27 participants
Improved or No Sinus Infection
25
  96.2%
18
  66.7%
No Change
1
   3.8%
8
  29.6%
Worse
0
   0.0%
1
   3.7%
8.Secondary Outcome
Title Frequency of Second Procedure
Hide Description Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Medical Therapy
Hide Arm/Group Description:
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
18
  60.0%
9.Secondary Outcome
Title Return to Normal Activity
Hide Description Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure
Time Frame 2 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description:
Subjects treated with balloon sinus dilation
Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: Days
1.8  (1.6) 1.3  (1.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Balloon Sinus Dilation Medical Therapy
Hide Arm/Group Description Subjects treated with balloon sinus dilation Subjects treated with medical therapy as needed per the subject's specific disease and as determined by the investigator's clinical judgement.
All-Cause Mortality
Balloon Sinus Dilation Medical Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Balloon Sinus Dilation Medical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      0/30 (0.00%)    
Injury, poisoning and procedural complications     
Facial Pain   1/29 (3.45%)  1 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Balloon Sinus Dilation Medical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/29 (58.62%)      18/30 (60.00%)    
Ear and labyrinth disorders     
Eustachian Tube Dysfunction  1/29 (3.45%)  1 0/30 (0.00%)  0
Gastrointestinal disorders     
Gastroesophageal reflux  0/29 (0.00%)  0 1/30 (3.33%)  1
Gastroenteritis  1/29 (3.45%)  1 0/30 (0.00%)  0
General disorders     
Pyrexia  1/29 (3.45%)  1 0/30 (0.00%)  0
Immune system disorders     
Cervical Lymphadenopathy  1/29 (3.45%)  1 0/30 (0.00%)  0
Infections and infestations     
Bronchitis  2/29 (6.90%)  2 2/30 (6.67%)  2
Sinusitis  2/29 (6.90%)  3 10/30 (33.33%)  18
Upper Respiratory Infection  3/29 (10.34%)  3 7/30 (23.33%)  7
Dental abcess  0/29 (0.00%)  0 1/30 (3.33%)  1
Pneumonia, aspiration  1/29 (3.45%)  1 0/30 (0.00%)  0
Mononucleosis  0/29 (0.00%)  0 1/30 (3.33%)  1
Pharyngitis  2/29 (6.90%)  3 1/30 (3.33%)  1
Injury, poisoning and procedural complications     
Nasal Fracture  1/29 (3.45%)  1 0/30 (0.00%)  0
Nausea  1/29 (3.45%)  1 0/30 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Hernia, abdominal  1/29 (3.45%)  1 0/30 (0.00%)  0
Arthritis, Psoriatic  0/29 (0.00%)  0 1/30 (3.33%)  1
Nervous system disorders     
Headache  1/29 (3.45%)  1 1/30 (3.33%)  1
Migraine, ocular  1/29 (3.45%)  1 0/30 (0.00%)  0
Vasovagal Reaction  1/29 (3.45%)  1 0/30 (0.00%)  0
Reproductive system and breast disorders     
Infertility  0/29 (0.00%)  0 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders     
Hyposmia  1/29 (3.45%)  1 0/30 (0.00%)  0
Nasal Congestion  0/29 (0.00%)  0 1/30 (3.33%)  1
Nodules of Vocal Code  0/29 (0.00%)  0 1/30 (3.33%)  1
Rhinitis Medicamentosa  1/29 (3.45%)  1 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders     
Poison Ivy rash  1/29 (3.45%)  1 0/30 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Patricia Chen
Organization: Acclarent, Inc
Phone: 949-453-6408
EMail: pchen126@its.jnj.com
Layout table for additonal information
Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01714687    
Other Study ID Numbers: CPR005030
First Submitted: October 24, 2012
First Posted: October 26, 2012
Results First Submitted: October 18, 2018
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019