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

NCT06264141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Recurrent Acute Rhinosinusitis

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.

Sponsors & Collaborators

  • Sanotize Research and Development corp.

    lead INDUSTRY

Principal Investigators

  • Keith Moore, PharmD · Sanotize Research and Development corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2025-02-22
Completion
2025-11-22

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264141 on ClinicalTrials.gov