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ACTIVE NOT RECRUITING
NCT06264141
PHASE2

Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis

Sponsor: Sanotize Research and Development corp.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DEVICE

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