S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps (RESOLVE_II)

Intersect ENT

Status and phase: Completed; Phase 3

Conditions: Nasal Polyposis; Chronic Sinusitis

Treatments: Drug: S8 Sinus Implant; Procedure: Sham; Drug: Mometasone furoate nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT02291549

P500-1113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria:

• 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

Exclusion criteria:

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 2 patient groups

Treatment

Experimental group

Description:

In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses Mometasone furoate nasal spray (200mcg) once daily

Treatment:

Drug: Mometasone furoate nasal spray

Drug: S8 Sinus Implant

Control

Sham Comparator group

Description:

In-office bilateral sham procedure Mometasone furoate nasal spray (200mcg) once daily

Treatment:

Drug: Mometasone furoate nasal spray

Procedure: Sham