Chronic Sinusitis, Ethmoidal
Conditions
Keywords
Steroid-eluting sinus implant, Mometasone furoate, Endoscopic sinus surgery
Brief summary
Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control (post-op standard of care) group and followed for 6 months.
Detailed description
This prospective, randomized, controlled, blinded trial aimed to assess the efficacy of a drug-eluting sinus implant placed following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids, compared to the same standard of care alone (control). Patients returned for follow-up examination at 2 weeks and again at 1, 3 and 6 months after placement. Follow-up examination consisted of patient-reported outcomes and endoscopic grading by clinical investigators and an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
Interventions
COMBINATION_PRODUCTSteroid-eluting sinus implant
PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days
Post-op standard of care including debridement, irrigation, and/or topical steroids
Sponsors
Intersect ENT
Collin County Ear Nose & Throat
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients were wearing eye masked and noise-cancelling headsets during placement and follow-up endoscopies. The primary outcome was assessed by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
Intervention model description
Patients assigned to the treatment group underwent a bilateral in-office placement of a steroid-eluting sinus implant 7 days following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids. Patients randomized to the control group received same standard of care alone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of chronic rhinosinusitis, defined by the AAO-HNS 2015 guidelines, including presence of bilateral ethmoid disease. * ESS including bilateral ethmoidectomy with middle meatal antrostomy within 7 days prior to scheduled implant placement. Concurrent septoplasty and surgical treatment of the other paranasal sinuses also permitted.
Exclusion criteria
* Known history of intolerance to corticosteroids or an oral steroid-dependent condition. * Known history of immune deficiency, insulin-dependent diabetes, cataracts, or glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation Score | Change from baseline to Day 90 | Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review. |
Countries
United States
Participant flow
Recruitment details
A total of 45 patients were recruited at one clinical site between November 9, 2015 and May 24, 2016, of whom 40 met final eligibility.
Pre-assignment details
Participants underwent endoscopic sinus surgery, including bilateral ethmoidectomy with middle meatal antrostomy. Concurrent septoplasty and surgical treatment of the other paranasal sinuses were also permitted. Participants returned at 7 days post-op and those meeting final eligibility underwent baseline assessment and group assignment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Steroid-eluting sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids) | 20 |
| Control Post-op standard of care (i.e. debridement, irrigation, and topical steroids) | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control | Total | Treatment |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 10.83 | 50.1 years STANDARD_DEVIATION 11.82 | 48.6 years STANDARD_DEVIATION 12.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 37 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of allergic rhinitis diagnosed by physician | 9 Participants | 19 Participants | 10 Participants |
| History of allergies Environmental | 5 Participants | 13 Participants | 8 Participants |
| History of allergies Food | 2 Participants | 4 Participants | 2 Participants |
| History of allergies None | 8 Participants | 15 Participants | 7 Participants |
| History of allergies Other | 8 Participants | 16 Participants | 8 Participants |
| History of aspirin exacerbated respiratory disease (AERD) | 0 Participants | 0 Participants | 0 Participants |
| History of asthma diagnosed by physician | 4 Participants | 10 Participants | 6 Participants |
| History of smoking Current smoker | 1 Participants | 2 Participants | 1 Participants |
| History of smoking Former smoker | 4 Participants | 10 Participants | 6 Participants |
| History of smoking Never smoked | 15 Participants | 28 Participants | 13 Participants |
| Number of prior ESS 1 ESS | 4 Participants | 5 Participants | 1 Participants |
| Number of prior ESS 2 ESS | 1 Participants | 1 Participants | 0 Participants |
| Number of prior ESS 3 ESS | 0 Participants | 1 Participants | 1 Participants |
| Number of prior ESS 4 ESS | 1 Participants | 2 Participants | 1 Participants |
| Number of prior ESS None | 14 Participants | 31 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 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 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 19 Participants | 37 Participants | 18 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 6 / 20 | 4 / 20 |
| serious Total, serious adverse events | 2 / 20 | 1 / 20 |
Outcome results
Primary
Inflammation Score
Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.
Time frame: Change from baseline to Day 90
Population: Intent-to-treat population (all randomized participants). Values adjusted for any surgical or steroid intervention by caring forward last observation before intervention. Scores for 9 participants (7 treatment, 2 control) were missing because the video-endoscopies for those participants had insufficient content to allow grading.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sinus Implant+Post-op Standard of Care | Inflammation Score | Baseline | 26.7 units on a scale | Standard Deviation 8.24 |
| Sinus Implant+Post-op Standard of Care | Inflammation Score | Day 90 | 21.5 units on a scale | Standard Deviation 20.84 |
| Sinus Implant+Post-op Standard of Care | Inflammation Score | Change from baseline | -5.2 units on a scale | Standard Deviation 24.36 |
| Post-op Standard of Care | Inflammation Score | Baseline | 26.8 units on a scale | Standard Deviation 6.27 |
| Post-op Standard of Care | Inflammation Score | Day 90 | 17.6 units on a scale | Standard Deviation 8.83 |
| Post-op Standard of Care | Inflammation Score | Change from baseline | -9.7 units on a scale | Standard Deviation 9.2 |
p-value: 0.4709t-test, 2 sided