Trial Outcomes & Findings for The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant (NCT NCT02668302)
NCT ID: NCT02668302
Last Updated: 2018-10-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Change from baseline to Day 90
Results posted on
2018-10-12
Participant Flow
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.
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.
Participant milestones
| Measure |
Sinus Implant+Post-op Standard of Care
Bilateral in-office placement a steroid-eluting sinus implant in the ethmoid sinuses in addition to post-op standard of care, including debridement, irrigation, and topical steroids
|
Post-op Standard of Care
Post-op standard of care, including debridement, irrigation, and topical steroids
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sinus Implant+Post-op Standard of Care
Bilateral in-office placement a steroid-eluting sinus implant in the ethmoid sinuses in addition to post-op standard of care, including debridement, irrigation, and topical steroids
|
Post-op Standard of Care
Post-op standard of care, including debridement, irrigation, and topical steroids
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
Baseline characteristics by cohort
| Measure |
Treatment
n=20 Participants
Steroid-eluting sinus implant placement following ethmoidectomy in addition to post-op standard of care (i.e. debridement, irrigation, and topical steroids)
|
Control
n=20 Participants
Post-op standard of care (i.e. debridement, irrigation, and topical steroids)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 12.81 • n=39 Participants
|
51.6 years
STANDARD_DEVIATION 10.83 • n=41 Participants
|
50.1 years
STANDARD_DEVIATION 11.82 • n=35 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
37 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Number of prior ESS
None
|
17 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
31 Participants
n=35 Participants
|
|
Number of prior ESS
1 ESS
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Number of prior ESS
2 ESS
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Number of prior ESS
3 ESS
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Number of prior ESS
4 ESS
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
History of asthma diagnosed by physician
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
History of allergic rhinitis diagnosed by physician
|
10 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
History of allergies
None
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
History of allergies
Environmental
|
8 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
History of allergies
Food
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
History of allergies
Other
|
8 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
History of aspirin exacerbated respiratory disease (AERD)
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
History of smoking
Never smoked
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
History of smoking
Former smoker
|
6 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
History of smoking
Current smoker
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to Day 90Population: 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.
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.
Outcome measures
| Measure |
Sinus Implant+Post-op Standard of Care
n=20 Participants
Bilateral in-office placement a steroid-eluting sinus implant in the ethmoid sinuses in addition to post-op standard of care, including debridement, irrigation, and topical steroids
|
Post-op Standard of Care
n=20 Participants
Post-op standard of care, including debridement, irrigation, and topical steroids
|
|---|---|---|
|
Inflammation Score
Baseline
|
26.7 units on a scale
Standard Deviation 8.24
|
26.8 units on a scale
Standard Deviation 6.27
|
|
Inflammation Score
Day 90
|
21.5 units on a scale
Standard Deviation 20.84
|
17.6 units on a scale
Standard Deviation 8.83
|
|
Inflammation Score
Change from baseline
|
-5.2 units on a scale
Standard Deviation 24.36
|
-9.7 units on a scale
Standard Deviation 9.20
|
Adverse Events
Treatment
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Control
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=20 participants at risk
Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids
|
Control
n=20 participants at risk
Post-op standard of care, including debridement, irrigation, and topical steroids
|
|---|---|---|
|
Reproductive system and breast disorders
Pelvic abscess
|
5.0%
1/20 • 6 months
|
0.00%
0/20 • 6 months
|
|
Cardiac disorders
Myocardial Infarction
|
5.0%
1/20 • 6 months
|
0.00%
0/20 • 6 months
|
|
Surgical and medical procedures
Synechiae nose
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • 6 months
|
Other adverse events
| Measure |
Treatment
n=20 participants at risk
Bilateral in-office placement of a steroid-eluting sinus implant following ethmoidectomy in addition to post-op standard of care, including debridement, irrigation, and topical steroids
|
Control
n=20 participants at risk
Post-op standard of care, including debridement, irrigation, and topical steroids
|
|---|---|---|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • 6 months
|
5.0%
1/20 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Congestion chest
|
5.0%
1/20 • 6 months
|
0.00%
0/20 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Congestion nasal
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • 6 months
|
|
Immune system disorders
Allergy aggravated
|
0.00%
0/20 • 6 months
|
5.0%
1/20 • 6 months
|
|
Infections and infestations
Cellulitis nasal
|
5.0%
1/20 • 6 months
|
0.00%
0/20 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
5.0%
1/20 • 6 months
|
10.0%
2/20 • 6 months
|
|
Ear and labyrinth disorders
Pain ear
|
5.0%
1/20 • 6 months
|
0.00%
0/20 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • 6 months
|
0.00%
0/20 • 6 months
|
Additional Information
Keith E Matheny, MD (Principal Investigator)
Collin County ENT
Phone: (972) 596-4005
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place