NCT01714687: CABERNET

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

Completed NA Results posted Last updated 12 July 2024

What this trial tests

NA trial testing balloon sinus dilation in Recurrent Acute Rhinosinusitis in 59 participants. Completed in 1 April 2016.

Timeline

1 October 2012

Primary endpoint
1 October 2015

1 April 2016

Quick facts

Lead sponsor	Integra LifeSciences Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	59
Start date	1 October 2012
Primary completion	1 October 2015
Estimated completion	1 April 2016
Sites	5 locations across United States

Drugs / interventions tested

• balloon sinus dilation
• medical therapy

Conditions studied

• Recurrent Acute Rhinosinusitis — all drugs for Recurrent Acute Rhinosinusitis →

Sponsor

Integra LifeSciences Corporation — full company profile →

Who can join

19 and older, any sex, with Recurrent Acute Rhinosinusitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CSS Total Score Change From Baseline to 24 Week Visit Primary · 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 outcome

Group	Value	95% CI
Balloon Sinus Dilation	37.3	± 24.4
Medical Therapy	21.8	± 29.0

CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks Secondary · 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 i

CSS Symptom Sub-score Change at Procedure

Group	Value	95% CI
Balloon Sinus Dilation	3.9	± 19.4
Medical Therapy	-7.5	± 21.4

CSS Symptom Sub-score Change at Week 8

Group	Value	95% CI
Balloon Sinus Dilation	39.6	± 33.7
Medical Therapy	24.1	± 39.6

CSS Symptom Sub-score Change at Week 16

Group	Value	95% CI
Balloon Sinus Dilation	46.3	± 32.0
Medical Therapy	30.1	± 38.9

CSS Symptom Sub-score Change at Week 24

Group	Value	95% CI
Balloon Sinus Dilation	48.7	± 28.7
Medical Therapy	27.2	± 40.1

CSS Symptom Sub-score Change at Week 32

Group	Value	95% CI
Balloon Sinus Dilation	45.8	± 33.8
Medical Therapy	35.4	± 24.7

CSS Symptom Sub-score Change at Week 40

Group	Value	95% CI
Balloon Sinus Dilation	52.9	± 32.7
Medical Therapy	29.8	± 22.0

CSS Symptom Sub-score Change at Week 48

Group	Value	95% CI
Balloon Sinus Dilation	53.8	± 24.6
Medical Therapy	33.3	± 25.9

CSS Medication Sub-score Change at Procedure

Group	Value	95% CI
Balloon Sinus Dilation	-1.5	± 17.1
Medical Therapy	-7.0	± 17.4

RSDI Total and Sub-score Changes From Baseline Over 48 Weeks Secondary · 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 emot

RSDI Total Change at Procedure

Group	Value	95% CI
Balloon Sinus Dilation	-1.0	± 13.4
Medical Therapy	2.5	± 9.0

RSDI Total Change at Week 8

Group	Value	95% CI
Balloon Sinus Dilation	-32.9	± 26.8
Medical Therapy	-17.9	± 30.9

RSDI Total Change at Week 24

Group	Value	95% CI
Balloon Sinus Dilation	-35.6	± 28.2
Medical Therapy	-18.7	± 27.4

RSDI Total Change at Week 48

Group	Value	95% CI
Balloon Sinus Dilation	-36.9	± 21.1
Medical Therapy	-17.2	± 14.9

RSDI Physical Sub-score Change at Procedure

Group	Value	95% CI
Balloon Sinus Dilation	-1.8	± 5.7
Medical Therapy	0.5	± 3.4

RSDI Physical Sub-score Change at Week 8

Group	Value	95% CI
Balloon Sinus Dilation	-14.5	± 11.2
Medical Therapy	-8.6	± 12.4

RSDI Physical Sub-score Change at Week 24

Group	Value	95% CI
Balloon Sinus Dilation	-15.4	± 10.8
Medical Therapy	-9.1	± 12.1

RSDI Physical Sub-score Change at Week 48

Group	Value	95% CI
Balloon Sinus Dilation	-15.1	± 9.3
Medical Therapy	-8.5	± 6.3

Medication Usage at 24 and 48 Weeks Secondary · 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.

Oral Antibiotics at 24 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	0.7	± 2.3
Medical Therapy	2.9	± 6.6

Oral Antibiotics at 48 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	0.5	± 2.1
Medical Therapy	2.0	± 3.1

Injected Antibiotics at 24 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	0.0	± 0.0
Medical Therapy	0.0	± 0.0

Injected Antibiotics at 48 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	0.0	± 0.2
Medical Therapy	0.0	± 0.0

Oral Steroids at 24 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	0.6	± 2.8
Medical Therapy	1.0	± 3.1

Oral Steroids at 48 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	0.7	± 2.4
Medical Therapy	0.0	± 0.0

Nasal Steroid Sprays at 24 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	10.5	± 19.0
Medical Therapy	21.5	± 24.0

Nasal Steroid Sprays at 48 Week Visit

Group	Value	95% CI
Balloon Sinus Dilation	10.3	± 19.8
Medical Therapy	24.0	± 29.4

Unscheduled Medical Care Visits Due to Sinusitis Secondary · 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.

Sinus-related visits through 24 weeks

Group	Value	95% CI
Balloon Sinus Dilation	0.2	± 0.8
Medical Therapy	0.9	± 1.3

Sinus-related visits through 48 Weeks

Group	Value	95% CI
Balloon Sinus Dilation	0.2	± 0.9
Medical Therapy	0.2	± 0.4

Sinus Infections and Sinus Severity - Part 1 Secondary · 24 Weeks and 48 Weeks

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

Sinus infections thru 24 wks

Group	Value	95% CI
Medical Therapy	0.2	± 0.4
Balloon Sinus Dilation	0.9	± 0.9

Sinus infections thru 48 wks

Group	Value	95% CI
Medical Therapy	0.2	± 0.4
Balloon Sinus Dilation	0.4	± 0.5

Sinus Infections and Sinus Severity - Part 2 Secondary · 24 Weeks

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

Severity of Sinus Symptoms thru 24 wks

Group	Value	95% CI
Medical Therapy	25
Balloon Sinus Dilation	16
Medical Therapy	1
Balloon Sinus Dilation	10
Medical Therapy	0
Balloon Sinus Dilation	1

Severity of Sinus Infections thru 24 wks

Group	Value	95% CI
Medical Therapy	25
Balloon Sinus Dilation	18
Medical Therapy	1
Balloon Sinus Dilation	8
Medical Therapy	0
Balloon Sinus Dilation	1

Frequency of Second Procedure Secondary · Up to 24 weeks

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

Group	Value	95% CI
Medical Therapy	18

Return to Normal Activity Secondary · 2 week

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

Group	Value	95% CI
Balloon Sinus Dilation	1.8	± 1.6
Medical Therapy	1.3	± 1.3

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Balloon Sinus Dilation

Serious: 1/29 (3%)

Deaths: 0/29

Medical Therapy

Serious: 0/30 (0%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	Balloon Sinus Dilation	Medical Therapy
Facial Pain	Injury, poisoning and procedural complications	—	—

Other adverse events (25 terms — click to expand)

Reaction	System	Balloon Sinus Dilation	Medical Therapy
Sinusitis	Infections and infestations	—	—
Upper Respiratory Infection	Infections and infestations	—	—
Bronchitis	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Dental abcess	Infections and infestations	—	—
Hyposmia	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonia, aspiration	Infections and infestations	—	—
Cervical Lymphadenopathy	Immune system disorders	—	—
Eustachian Tube Dysfunction	Ear and labyrinth disorders	—	—
Pyrexia	General disorders	—	—
Infertility	Reproductive system and breast disorders	—	—
Gastroesophageal reflux	Gastrointestinal disorders	—	—
Hernia, abdominal	Musculoskeletal and connective tissue disorders	—	—
Nasal Fracture	Injury, poisoning and procedural complications	—	—
Mononucleosis	Infections and infestations	—	—
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	—	—
Nausea	Injury, poisoning and procedural complications	—	—
Nodules of Vocal Code	Respiratory, thoracic and mediastinal disorders	—	—
Migraine, ocular	Nervous system disorders	—	—
Poison Ivy rash	Skin and subcutaneous tissue disorders	—	—
Arthritis, Psoriatic	Musculoskeletal and connective tissue disorders	—	—
Rhinitis Medicamentosa	Respiratory, thoracic and mediastinal disorders	—	—
Gastroenteritis	Gastrointestinal disorders	—	—
Vasovagal Reaction	Nervous system disorders	—	—

Most-reported serious reactions: Facial Pain.

Data from ClinicalTrials.gov NCT01714687 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.