S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
Condition: Chronic Sinusitis; Nasal Polyposis
MeSH terms: Sinusitis; Nasal Polyps; Chronic Disease
Intervention: S8 Sinus Implant; Mometasone furoate nasal spray; Sham
Intervention 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; 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.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Participants were blindfolded and earmuffed during the baseline procedure and follow-up endoscopic examinations. Implants were removed at Day 60 to allow blinded assessment of bilateral polyp grade at Day 90 by a centralized videoendoscopy review by a panel of 3 independent sinus surgeons.
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: endoscopic sinus surgery; corticosteroid; chronic rhinosinusitis; mometasone furoate; polyposis

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.
    

Eligibility 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