Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Recurrent Acute Rhinosinusitis Device: balloon sinus dilation Other: medical therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
Actual Study Start Date : October 1, 2012
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : April 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Active Comparator: balloon sinus dilation
Balloon sinus dilation will be conducted in-office under local anesthesia.
Device: balloon sinus dilation
Other Name: balloon sinuplasty

Other: medical therapy
Other Name: medical management

Active Comparator: medical therapy
Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.
Other: medical therapy
Other Name: medical management




Primary Outcome Measures :
  1. CSS Total Score Change From Baseline to 24 Week Visit [ Time Frame: 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 Outcome Measures :
  1. CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks [ Time Frame: 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.

  2. RSDI Total and Sub-score Changes From Baseline Over 48 Weeks [ Time Frame: 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).


  3. Medication Usage at 24 and 48 Weeks [ Time Frame: 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.

  4. Unscheduled Medical Care Visits Due to Sinusitis [ Time Frame: 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.

  5. Sinus Infections and Sinus Severity - Part 1 [ Time Frame: 24 Weeks and 48 Weeks ]
    Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.

  6. Sinus Infections and Sinus Severity - Part 2 [ Time Frame: 24 Weeks ]
    Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.

  7. Frequency of Second Procedure [ Time Frame: Up to 24 weeks ]
    Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.

  8. Return to Normal Activity [ Time Frame: 2 week ]
    Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714687


Locations
Layout table for location information
United States, Alabama
Birmingham, Alabama, United States, 35242
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Nevada
Las Vegas, Nevada, United States, 89113
United States, Texas
Dallas, Texas, United States, 75231
McKinney, Texas, United States, 75070
Sponsors and Collaborators
Acclarent
Investigators
Layout table for investigator information
Principal Investigator: Ashley Sikand, MD Ear Nose and Throat Consultants of Nevada
Principal Investigator: Ford Albritton, MD Texas Institute for Sinus & Respiratory Disease
Layout table for additonal information
Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01714687    
Other Study ID Numbers: CPR005030
First Posted: October 26, 2012    Key Record Dates
Results First Posted: March 11, 2019
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication planned in the future

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases