A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis

ClinicalTrials.gov identifier: NCT02734849

Summary: This is a phase 2 study to evaluate multiple doses of AK001 (a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis) across 2 active doses. Pharmacodynamic activity will also be evaluated.

Inclusion Criteria:

  • 18 – 65 yr patient with chronic rhinosinusitis with nasal polyps
  • TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale
  • History of sinusitis symptoms
  • SNOT-22 ≥30
  • No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings

Exclusion Criteria:

  • Use of systemic corticosteroids within 6 weeks of screening
  • Chronic use of antibiotic therapy within 3 months prior to Screening
  • Nasal surgery (including polypectomy) within 6 months prior to Screening
  • Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half‑lives, whichever is longer

Contact: Amber Luong, MD, PhD

Randomized Double-blinded Controlled Trial of Oral Anti-fungal for the Treatment of Fungal Sensitive Chronic Rhinosinusitis with Nasal Polyps

ClinicalTrials.gov identifier: NCT02285283

Summary: The purpose of this randomized controlled double-blinded trial is to determine if the addition of an oral antifungal to typical post-operative medical therapy can prevent or reduce the incidence of recurrence of nasal polyps in fungal sensitive patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Inclusion Criteria:

  • 18 – 75 yr patient with chronic rhinosinusitis with nasal polyps scheduled to undergo medically-indicated endoscopic sinus surgery
  • Meet criteria for diagnosis of CRS with nasal polyps undergoing medically indicated sinus surgery

Exclusion Criteria:

  • cystic fibrosis
  • aspirin exacerbated respiratory disease
  • uncontrolled or unstable chronic diseases such as uncontrolled diabetes
  • active or history of cancer
  • HIV positive
  • history of liver or kidney disease
  • history of disease with effects on immune system
  • pregnant
  • allergy to triazole antifungals

Contact: Amber Luong, MD, PhD

RESOLVE II Clinical Evaluation of Safety and Efficacy of S8 Sinus Implant in Chronic Sinusitis Patients

ClinicalTrials.gov identifier: NCT02291549

Summary: The RESOLVE II Study will assess the safety and efficacy of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who present with recurrent sinus obstruction. This randomized, single-blind, parallel arm, concurrently controlled, multicenter study that will enroll 300 patients.

Adult patients (age ≥ 18 years) diagnosed with chronic sinusitis who underwent prior bilateral total ethmoidectomy but are currently indicated for repeat Endoscopic Sinus Surgery because they present with recurrent symptoms and ethmoid sinus obstruction due to bilateral polyposis (minimum grade 2 on each side), with or without obstructive mucosal edema and/or scarring/adhesions, and in whom placement of the S8 Sinus Implant is both feasible and medically appropriate.

Key Eligibility Criteria:

  • Confirmed diagnosis of chronic sinusitis
  • Previous endoscopic sinus surgery (ESS) including bilateral total ethmoidectomy
  • Nasal obstruction/congestion symptoms despite use of intranasal steroid irrigations or sprays
  • 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 (e.g. oral, parenteral, injection into polyps) and/or sinus steroid irrigations within the preceding 1 year

Contact: Amber Luong, MD, PhD

Evaluation of Novel Bacterial Rapid Diagnostic Test Kit for Acute Bacterial Rhinosinusitis Compared to Bacterial Culture

Summary: The goal of this proposal is to determine the comparative efficacy of the new rapid point-of-care test to bacterial culture as the current optimal diagnostic tool for acute bacterial rhinosinusitis.

Inclusion: Patient complaining of symptoms consistent with acute rhinosinusitis (ARS). All ARS subjects will have anterior or posterior purulent nasal drainage with nasal obstruction or facial pain/pressure/fullness less than 10 days in duration. Subjects must be >18 years of age and have a documented primary care physician.

Exclusion: Subjects with a prior history of sinus surgery will be excluded due to the modification of sinonasal anatomy with surgery.

Contact: William Yao, MD

An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

ClinicalTrials.gov identifier: NCT02600559

Summary: This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.

Inclusion Criteria include, but are not limited to:

  • Subject is a male or female aged 6 months to 17 years, inclusive
  • Subject has a history of otitis media requiring bilateral tympanostomy tube placement
  • Subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria include, but are not limited to:

  • Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement
  • Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
  • Subject has a history of sensorineural hearing loss

Contact: Soham Roy, MD