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Chronic SinusitisPhase 2/3RESOLVENCT01732536

Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

A Phase 2/3 study testing S8 Sinus Implant and Mometasone furoate nasal spray in people with Chronic Sinusitis and Nasal Polyps, run by Intersect ENT at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Sinusitis, Nasal Polyps
What is being tested?
S8 Sinus Implant and Mometasone furoate nasal spray
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
19 sitesUnited States
Study dates
Jan 2013to May 2014
Phase
Phase 2/3
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

  • Candidates for this study had to meet ALL of the following inclusion criteria:
  • 1. General Inclusion Criteria
  • Patient has provided written informed consent using a form approved by the reviewing IRB.
  • Patient is ≥ 18 years of age.
  • Patient is willing and able to comply with protocol requirements.
  • Patient has a previous confirmed diagnosis of CS defined as inflammation of the mucosa of the paranasal sinuses.
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  • Patient has undergone bilateral total ethmoidectomy (must be at least 90 day beyond the date of last sinus surgery).
  • Patient has recurrent bilateral sinus obstruction due to polyposis (Grades 1 through 3 only).
  • Patient must have a Grade 2 polyposis on at least 1 ethmoid side.
  • Patient is able to tolerate the use of Nasonex topical intranasal steroid spray once daily.
  • Patient is indicated for a repeat ESS per the study definition. Patient must have: (i) a minimum symptom burden on the SNOT 22, consisting of a minimum score of 2 on at least 2 of the 5 hallmark symptoms of CS (nasal blockage, post-nasal discharge, thick nasal discharge, facial pain/pressure, and decreased sense of smell); (ii) persistent symptoms of CS despite ongoing treatment with topical intranasal steroid irrigations or sprays at least once daily for at least 2 weeks preceding enrollment; (iii) had treatment with a high-dose form of steroids (e.g., oral, parenteral, injection into polyps) and/or sinus steroid irrigations within the preceding 2 years, or refused such therapy due to intolerance/side effects; (iv) a known history of repeated courses of treatment with aggressive steroid therapy for recurrent sinusitis; and (v) endoscopic evidence of polyp recurrence, scarring, and/or obstructive mucosal edema.
  • Patient is able to tolerate use of topical/local anesthesia and the implant procedure in an office or clinic setting.
  • In the opinion of the physician, treatment with S8 Sinus Implant or sham procedure is technically feasible (able to pass 5-9 mm device into middle meatus) bilaterally.
  • Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study.
  • Female patients of child-bearing potential must agree to use consistent and acceptable method/s of birth control during the course of the study.

Who cannot join

  • Candidates were excluded if they met ANY of the following criteria:
  • General Exclusion Criteria
  • Patient had bilateral total ethmoidectomy less than 90 days previously.
  • Patient had Propel implanted postoperatively less than 90 days previously.
  • Patient has presence of adhesions/synechiae Grades 3 or 4.
  • Patient has presence of severe scarring or adhesions within the ethmoid cavity itself.
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  • Patient has presence of Grade 4 polyposis.
  • Patient has known history of immune deficiency (e.g., IGG] subclass deficiency or IGA deficiency, HIV).
  • Patient has concurrent condition requiring active chemotherapy and/or immunotherapy management for the disease (e.g., cancer, HIV, etc.).
  • Patient has oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD), asthma or other condition.
  • Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate (MF).
  • Patient has known history of resistance or poor response to oral steroids.
  • Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for device delivery (e.g., severe septal deviation, septal spur, very small middle meatus, total obstruction of the nasal passage with severe scarring, polyposis).
  • Patient has clinical evidence of acute bacterial sinusitis (e.g., acute increase in purulent discharge, fever, facial pain etc.).
  • Patient has clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on prior CT scan, necrotic sinus tissue, etc.).
  • Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 6 month follow-up period.
  • Patient is currently participating in or recently participated in another clinical trial (within the last 30 days).
  • Patient has history of insulin dependent diabetes mellitus.
  • Patient has previously undergone ESS and experienced a CSF leak or has residual compromised vision as a result of a complication in a prior ESS procedure.
  • Patient has completely resected middle turbinate.
  • Patient has known dehiscence of the lamina papyracea.
  • Patient has evidence of active viral illness (e.g., tuberculosis, ocular herpes simplex, chickenpox, or measles).
  • Ocular Exclusion Criteria
  • Patient has history or diagnosis of glaucoma or ocular hypertension (baseline or a known prior ocular exam indicating IOP >21 mm Hg)
  • Patient has closed angle (with or without the presence of peripheral anterior synechiae on gonioscopy)
  • Patient has presence in either eye of: (i) posterior subcapsular cataract, (ii) nuclear sclerosis of Grade +3 or higher; or (iii) cortical cataract of Grade +3 or higher.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Albany ENT & Allergy Services

    Albany, New York, 12206

  • California Sinus Centers

    Atherton, California, 94027

  • ENT of Georgia

    Atlanta, Georgia, 30342

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Bethlehem ENT Specialty Physicians Associates

    Bethlehem, Pennsylvania, 18017

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University, Department of Otolaryngology-Head & Neck Surgery

    Chicago, Illinois, 60611

  • Colorado Ear, Nose, Throat & Allergy

    Colorado Springs, Colorado, 80909

  • ENT and Allergy Associates

    Lake Success, New York, 11042

  • Cedars-Sinai Medical Center, Sinus Center of Excellence

    Los Angeles, California, 90048

  • Advanced ENT & Allergy

    Louisville, Kentucky, 40207

  • South Florida ENT Associates

    Miami, Florida, 33176

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53266

  • Eastern Virginia Medical School Department of Otolaryngology

    Norfolk, Virginia, 23507

  • University of Pennsylvania, Dept of Otolaryngology-Head & Neck Surgery

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Science University-Dept. of Otolaryngology Head and Neck Surgery

    Portland, Oregon, 97239

  • Sacramento Ear, Nose and Throat

    Sacramento, California, 95815

  • Intermountain Ear, Nose & Throat Center

    Salt Lake City, Utah, 84102

  • Piedmont Ear, Nose & Throat Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction

The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.

Read the detailed description

RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days, with the majority of drug released within 60 days.

Being tested
S8 Sinus Implant, Sham procedure, Mometasone furoate nasal spray
Keywords
corticosteroid-eluting sinus implant, chronic rhinosinusitis, mometasone furoate, polyposis
Medical subject headings
Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S8 Sinus ImplantDrug

    Also called SINUVA (mometasone furoate) sinus implant

    In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

  • Sham procedureProcedure or surgery

    In-office bilateral sham procedure

  • Mometasone furoate nasal sprayDrug

    Also called Nasonex Nasal Spray

    Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Study groups in NCT01732536
Study groupRoleWhat they receive
S8 Sinus ImplantExperimentalIn-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily
Receives: Drug: S8 Sinus Implant; Drug: Mometasone furoate nasal spray
ControlSham comparatorIn-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily
Receives: Procedure: Sham procedure; Drug: Mometasone furoate nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nasal Obstruction/Congestion Score

    Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in

    Measured: 90 days

  2. Bilateral Polyp Grade

    Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.

    Measured: 90 days

Secondary outcomes (4)

  1. Ethmoid Sinus Obstruction

    Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.

    Measured: 90 days

  2. Bilateral Polyp Grade

    Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.

    Measured: 90 days, 6 months

  3. Nasal Obstruction Symptom Evaluation (NOSE) Score

    NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.

    Measured: 6 months

  4. Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)

    To be indicated for RESS, the following criteria had to be met:

    • Continued to use topical intranasal steroids daily;
    • Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use
    • Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and
    • Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade >=2 on at least one side)

    Measured: 90 days, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionNov 2013
  4. Study completionMay 2014

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01732536
Sponsor's protocol ID
P500-1012
Acronym
RESOLVE
Status last verified
Jul 2018
First submitted
14 Nov 2012
Last updated
20 Jul 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No plan

Publications

  • Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.

    PubMed 25266981

  • Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.

    PubMed 26992115

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing S8 Sinus Implant and Mometasone furoate nasal spray in people with Chronic Sinusitis and Nasal Polyps, run by Intersect ENT at 19 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 15 inclusion and 26 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 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 Jul 2018). 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?

Nasal Obstruction/Congestion Score (time frame: 90 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 NCT01732536, which also lists 2 linked publications.

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 20 Jul 2018.

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