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Chronic SinusitisPhase 3RESOLVE_IINCT02291549

S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

A Phase 3 study testing S8 Sinus Implant and Mometasone furoate nasal spray in people with Chronic Sinusitis and Nasal Polyposis, run by Intersect ENT at 40 sites in United States.

Completed

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

Official record
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Trial summary

The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Sinusitis, Nasal Polyposis
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
300 participants
Where
40 sitesUnited States
Study dates
Dec 2014to Oct 2016
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

  • Confirmed diagnosis of chronic sinusitis
  • Patient has undergone bilateral total ethmoidectomy at least 90 days prior to screening
  • Patient has Nasal Obstruction/Congestion score of at least 2 (scale from 0 to 3) on at least 5 days during the 7 days following informed consent, despite use of topical intranasal steroid irrigations or sprays for at least 14 days preceding scoring, as documented in medication records
  • Indication for repeat ESS:
  • Complaints of at least 2 symptoms of chronic sinusitis: nasal obstruction/congestion, post-nasal discharge, thick nasal discharge, facial pain/pressure, or decreased sense of smell
  • Endoscopic evidence of bilateral sinus obstruction due to polyposis (minimum grade 2 on each side)
  • History of high-dose steroid use and/or sinus steroid irrigations within the preceding 1 year

Who cannot join

  • Patient has presence of polyposis grade 1, 1.5 or 4 on either side
  • Patient has presence of adhesions/synechiae grades 3 or 4
  • Patient has known history of immune deficiency
  • Patient has concurrent condition such as cancer or HIV requiring active chemotherapy and/or immunotherapy management for the disease
  • Patient has oral-steroid dependent condition such as COPD, asthma or other condition
  • Patient has known history of allergy or intolerance to corticosteroids or mometasone furoate
Show all 16Show fewer
  • Patient has presence of physical obstruction that would preclude access to either ethmoid sinus for implant 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
  • Patient has clinical evidence or suspicion of invasive fungal sinusitis
  • Patient has evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments during the 90-day follow-up period
  • Patient is currently participating in another clinical trial or has already participated in this clinical trial
  • Patient has history of insulin dependent diabetes mellitus
  • Patient has previously undergone ESS and experienced a cerebrospinal fluid (CSF) leak or has residual compromised vision as a result of a complication in a prior ESS procedure
  • Patient has known dehiscence of the lamina papyracea
  • Patient has evidence of active viral illness
  • Patient has known history or diagnosis of glaucoma or ocular hypertension (prior ocular exam with IOP>21 mm Hg and pressure lowering medication given) or posterior subcapsular cataract

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Albany ENT & Allergy

    Albany, New York, 12206

  • Breathe America/NM Sinus

    Albuquerque, New Mexico, 87109

  • ENT of Georgia

    Atlanta, Georgia, 30342

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Bethlehem Ear, Nose and Throat Associates

    Bethlehem, Pennsylvania, 18017

  • The University of Alabama Birmingham

    Birmingham, Alabama, 35233

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern Medical Faculty Foundation, Department of Otolaryngology

    Chicago, Illinois, 60611

  • Colorado ENT and Allergy

    Colorado Springs, Colorado, 80909

  • Charlotte Eye, Ear, Nose and Throat Associates

    Concord, North Carolina, 29025

  • Associated Surgical Specialists

    Covington, Louisiana, 70433

  • University of Texas

    Houston, Texas, 77030

  • Kaiser Permanente Orange County Irvine Medical Center

    Irvine, California, 92618

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Ear, Nose and Throat Consultants of Nevada

    Las Vegas, Nevada, 89128

  • Advanced ENT and Allergy

    Louisville, Kentucky, 40207

  • University of Miami

    Miami, Florida, 33136

  • South Florida ENT

    Miami, Florida, 33176

  • Medical College of Wisconsin - Greenway Clinic

    Milwaukee, Wisconsin, 53227

  • DuPage Medical Group

    Naperville, Illinois, 60540

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • Madison ENT & Facial Plastic Surgery

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10029

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Cache Valley ENT

    North Logan, Utah, 84341

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Reston ENT

    Reston, Virginia, 20190

  • Virginia ENT

    Richmond, Virginia, 23233

  • & Facial Plastic Surgery

    Riverview, Florida, 33578

  • Rontal Akervall Clinic

    Royal Oak, Michigan, 48073

  • Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.

    Sacramento, California, 95815

  • Intermountain/ENT Center of UT

    Salt Lake City, Utah, 84102

  • University of Utah

    Salt Lake City, Utah, 84132

  • GW Medical Facility Associates

    Washington D.C., District of Columbia, 20037

  • Iowa ENT Center

    West Des Moines, Iowa, 50265

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 in Chronic Sinusitis Patients With Recurrent Sinus Obstruction

The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.

Read the detailed description

The RESOLVE II Study is a randomized, sham-controlled, double-blind, parallel arm multicenter trial conducted in up to 45 clinical centers (academic and private) across the United States in 300 adults with chronic sinusitis, who are indicated for revision surgery because of recurring nasal obstruction/congestion symptoms and bilateral ethmoid polyposis.

Being tested
S8 Sinus Implant, Mometasone furoate nasal spray, Sham
Keywords
endoscopic sinus surgery, corticosteroid, 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

  • Mometasone furoate nasal sprayDrug

    Also called Nasonex

    Mometasone furoate nasal spray (200mcg) once daily

  • ShamProcedure or surgery

    Also called Sham procedure

    In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.

Study groups in NCT02291549
Study groupRoleWhat they receive
TreatmentExperimentalIn-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: Drug: Mometasone furoate nasal spray; Procedure: Sham

What is being measured

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

  1. Nasal Obstruction/Congestion Score

    Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.

    Measured: Day 30

  2. Bilateral Polyp Grade

    Polyp grade was determined by an independent panel of 3 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 indicated reduction (improvement) in bilateral polyp grade.

    Measured: Day 90

Secondary outcomes (5)

  1. Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)

    Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade >= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy.

    Measured: Day 90

  2. Ethmoid Sinus Obstruction

    Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 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 indicated reduction (improvement) in ethmoid sinus obstruction.

    Measured: Day 90

  3. Nasal Obstruction/Congestion Score

    Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms.

    Measured: Day 90

  4. Decreased Sense of Smell Score

    Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell.

    Measured: Day 90

  5. Facial Pain/Pressure Score

    Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms.

    Measured: Day 90

Timeline

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

  1. First posted14 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionOct 2016
  4. Study completionOct 2016

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02291549
Sponsor's protocol ID
P500-1113
Acronym
RESOLVE_II
Status last verified
Jul 2018
First submitted
11 Nov 2014
Last updated
15 Aug 2018
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kern RC, Stolovitzky JP, Silvers SL, Singh A, Lee JT, Yen DM, Iloreta AMC Jr, Langford FPJ, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK; RESOLVE II study investigators. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018 Apr;8(4):471-481. doi: 10.1002/alr.22084. Epub 2018 Jan 19.

    PubMed 29350840

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing S8 Sinus Implant and Mometasone furoate nasal spray in people with Chronic Sinusitis and Nasal Polyposis, run by Intersect ENT at 40 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 7 inclusion and 16 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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 9 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: Day 30). 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 NCT02291549, 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 15 Aug 2018.

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