Chronic Sinusitis
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).
Detailed description
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing function within the sinus anatomy to separate mucosal tissues, provide stabilization of the middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post surgical inflammation within the supported tissues. The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.
Interventions
DEVICESinus Stent with drug coating
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
DEVICENon Coated Sinus Stent
Sinus stent (visually identical) without drug coating
Sponsors
Intersect ENT
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration. * Patient is indicated for and has consented to FESS. * FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement. CT Imaging Inclusion Criteria: * CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure. * Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT.
Exclusion criteria
* insulin dependent diabetics * oral steroid dependent condition * glaucoma, ocular hypertension, posterior subcapsular cataracts * middle turbinate resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Sinuses Requiring Post-operative Intervention | 30-days | Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons. |
| Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure | 90 days | clinically significant IOP elevation is a change from baseline of \>10 mm Hg on sinus side with drug-coated implant but not on side with control implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Sinuses That Developed Frank Polyposis | 30 days | Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited in the United States between December 2009 and July 2010 from eleven otolaryngology-head and neck surgery centers by 31 surgeons representing both academic and private practices.
Pre-assignment details
Sinus randomization was performed at the end of successful endoscopic sinus surgery.
Participants by arm
| Arm | Count |
|---|---|
| Sinus Stent Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Sinus Stent |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants |
| Age, Continuous | 46.5 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 105 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 105 |
| serious Total, serious adverse events | 0 / 105 |
Outcome results
Primary
Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure
clinically significant IOP elevation is a change from baseline of \>10 mm Hg on sinus side with drug-coated implant but not on side with control implant
Time frame: 90 days
Population: Two patients did not have their ocular exam performed at day 90 (LTFU) but had ocular exams at earlier time points.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Drug-Coated Implant Side | Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure | 0 percentage of patients |
p-value: <0.0001Fisher Exact
Primary
Percentage of Sinuses Requiring Post-operative Intervention
Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.
Time frame: 30-days
Population: All 105 subjects were present for the primary endpoint exam. However n=96 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Drug-Coated Implant Side | Percentage of Sinuses Requiring Post-operative Intervention | 33.3 percentage of sinuses |
| Non-coated Implant Side | Percentage of Sinuses Requiring Post-operative Intervention | 46.9 percentage of sinuses |
p-value: 0.028McNemar
Secondary
Percentage of Sinuses That Developed Frank Polyposis
Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.
Time frame: 30 days
Population: All 105 subjects were present for this endpoint exam. However n=85 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Drug-Coated Implant Side | Percentage of Sinuses That Developed Frank Polyposis | 18.8 percentage of sinuses |
| Non-coated Implant Side | Percentage of Sinuses That Developed Frank Polyposis | 34.1 percentage of sinuses |
p-value: 0.0023McNemar