Chronic SinusitisPhase 3ADVANCE IINCT01253577
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
A Phase 3 study testing Sinus Stent with drug coating and Non Coated Sinus Stent in people with Chronic Sinusitis, run by Intersect ENT at 11 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Sinus Stent with drug coating and Non Coated Sinus Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2009to Oct 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- insulin dependent diabetics
- oral steroid dependent condition
- glaucoma, ocular hypertension, posterior subcapsular cataracts
- middle turbinate resection
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Austin ENT Clinics
Austin, Texas
Charlotte Eye, ENT Associates
Charlotte, North Carolina, 28210
Northwestern University
Chicago, Illinois, 60611
Colorado ENT & Allergy
Colorado Springs, Colorado, 80909
University of Texas SW Medical School
Dallas, Texas
Northshore University Health System
Evanston, Illinois, 60201
Central California ENT
Fresno, California, 93720
University of Texas Medical School
Houston, Texas, 77098
Advanced ENT & Allergy
Louisville, Kentucky, 40207
Eastern Virgina Medical School
Norfolk, Virginia, 23507
Intermountain ENT
Salt Lake City, Utah, 84102
About this study
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).
Read the 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.
- Conditions
- Chronic Sinusitis
- Being tested
- Sinus Stent with drug coating, Non Coated Sinus Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus Stent with drug coatingDevice
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
Non Coated Sinus StentDevice
Sinus stent (visually identical) without drug coating
| Study group | Role | What they receive |
|---|---|---|
| Drug Coated | Active comparator | Sinus stent coated with steroid Receives: Device: Sinus Stent with drug coating |
| Non coated | Placebo comparator | Sinus stent without drug coating Receives: Device: Non Coated Sinus Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30-days
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
Measured: 90 days
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intersect ENT
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley Marple, MD, Principal investigator, University of TexasNeil Bhattacharyya, MD, Principal investigator, Brighan & Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253577
- Sponsor's protocol ID
- P500-1009
- Acronym
- ADVANCE II
- Status last verified
- May 2015
- First submitted
- 2 Dec 2010
- Last updated
- 22 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Han JK, Marple BF, Smith TL, Murr AH, Lanier BJ, Stambaugh JW, Mugglin AS. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012 Jul-Aug;2(4):271-9. doi: 10.1002/alr.21044. Epub 2012 May 1.
PubMed 22550039
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT01253577
- Acronym / sponsor ID
- ADVANCE II / P500-1009
- Conditions
- Chronic Sinusitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Intersect ENTIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 13 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Coated | Active comparator | Device: Sinus Stent with drug coatingSinus stent coated with steroid |
| Non coated | Placebo comparator | Device: Non Coated Sinus StentSinus stent without drug coating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- insulin dependent diabetics
- oral steroid dependent condition
- glaucoma, ocular hypertension, posterior subcapsular cataracts
- middle turbinate resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinus Stent with drug coatingSinus stent coated with 370 ug of the corticosteroid mometasone furoate | Device | Drug Coated |
| Non Coated Sinus StentSinus stent (visually identical) without drug coating | Device | Non coated |
Primary outcome
Percentage of Sinuses Requiring Post-operative Intervention
Time frame: 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
Time frame: 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
1 secondary outcome
Percentage of Sinuses That Developed Frank Polyposis
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22550039Han JK, Marple BF, Smith TL, Murr AH, Lanier BJ, Stambaugh JW, Mugglin AS. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol. 2012 Jul-Aug;2(4):271-9. doi: 10.1002/alr.21044. Epub 2012 May 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Marple, MD principal investigator
University of Texas
Neil Bhattacharyya, MD principal investigator
Brighan & Women's Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sinus Stent with drug coating and Non Coated Sinus Stent in people with Chronic Sinusitis, run by Intersect ENT at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Sinuses Requiring Post-operative Intervention (time frame: 30-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01253577, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2015.