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Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis
Sponsor: Sanotize Research and Development corp.
Summary
A two-week therapy of nitric oxide nasal spray (NONS) vs Placebo (saline nasal spray) initiated immediately after the onset of a new Recurrent Acute Rhinosinusitis (RARS) episode to assess the acceleration to clinical success (cured/much improved symptoms), lack of use of intranasal corticosteroids (INCS) (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide releasing solution (NORS) platform therapy.
Official title: Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 2 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) Compared to Saline Nasal Spray as an Early Treatment for Recurrent Acute Rhinosinusitis (RARS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2024-01-16
Completion Date
2025-02-24
Last Updated
2025-01-06
Healthy Volunteers
No
Conditions
Interventions
Nitric Oxide Releasing Solution
The Sponsor designed a dual chamber nasal spray bottle for NORS administration. Components are mixed from two chambers to create the final NO-producing formulation. The liquid contains NO at 0.11 ppm\*hour, which acts as a viricidal agent. Instructions for storing, preparing, and administering the study treatment will be provided to participants.
Nasal spray with isotonic saline
The Sponsor designed a dual-chamber nasal spray bottle for NORS administration. The bottle will be filled with normal saline before being provided to the participant.
Locations (7)
Okanegan Clinical Trials
Kelowna, British Columbia, Canada
Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site)
Richmond, British Columbia, Canada
Cliantha Research
Mississauga, Ontario, Canada
Clinical Research of Ontario
Scarborough Village, Ontario, Canada
Intermed Groupe Santé
Chicoutimi, Quebec, Canada
Alpha Recherche Clinique LeBourneuf
Québec, Quebec, Canada
Alpha Recherche Clinique Val-Belair
Québec, Quebec, Canada