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

NCT06264141 | Completed Phase 2

• 1 other identifier: NONS-RARS-01
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Sinusitis; Nitric oxide; RARS; NONS; Nasal spray; Rhinosinusitis; Recurrent; Acute

Outcome Measures

Primary Outcomes (1)

• Primary endpoint is the time to sinus symptoms resolution

  To demonstrate superior efficacy of NONS compared to saline nasal spray in the early treatment of RARS. The primary objective is to demonstrate that NONS accelerates the time to achieve clinical success as determined by a higher percentage of participants having resolved or much improved sinusitis symptoms after 7 days of therapy.

  8 days

Secondary Outcomes (13)

• Time (days) to full recovery from sinusitis (participant reported)

  29 days

• Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success)

  29 days

• Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure

  29 days

• Time (days) to initiation of INCS

  29 days

• Proportion of participants requiring INCS

  Day 5, 8, 15 & 29

Other Outcomes (6)

• Number of ATB courses required as a rescue treatment

  29 days

• Time (days) to the initiation of NSAIDs

  29 days

• Proportion of participants requiring NSAIDs

  29 days

Study Arms (2)

Nitric Oxide Releasing Solution

ACTIVE COMPARATOR

Nasal spray with nitric oxide releasing solution (NORS) delivered five times per day spaced 1 to 4 hours between each dose while awake. Maximum volume delivered: 0.56 mL NORS @ 0.11ppm\*hrs

Drug: Nitric Oxide Releasing Solution

Placebo

PLACEBO COMPARATOR

Nasal spray with isotonic saline delivered five times per day spaced 1 to 4 hours between each dose while awake. Maximum volume delivered: 0.56 mL Saline @ 0.9%

Device: Nasal spray with isotonic saline

Interventions

Nitric Oxide Releasing Solution DRUG

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.

Also known as: Nitric Oxide Nasal Spray

Nitric Oxide Releasing Solution

Nasal spray with isotonic saline DEVICE

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.

Also known as: Normal saline, 0.9% saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least aged 18 years old at the time of consent (19 years depending on the age of majority in the Canadian province/territory).
• History of recurrent acute bacterial sinusitis (ABS) with at least three episodes in the previous 12 months with at least two episodes requiring ATB therapy (with symptom-free periods between infections).
• History of at least two moderately severe symptoms of acute rhinosinusitis (anterior (nasal) and posterior (postnasal drip) secretions, nasal obstruction (congestion), headache or facial pain/pressure during a typical RARS episode.
• If female, be surgically sterile or post-menopausal (no menses for at least 12 months), or if of childbearing potential, must be using an acceptable method of contraception such as a combination estrogen/progestin hormonal contraceptive (oral or injected) for at least 1 month prior to Screening, or such items as an intrauterine device (IUD), intrauterine system (IUS), transdermal hormonal implant, vaginal hormonal ring, or 2 forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge. Total abstinence is permitted. Must agree to agree continue using contraception for the duration of the study medication treatment.
• If male, be surgically sterile, or agree to use appropriate contraception (latex condom with spermicide) when engaging in sexual activity and agree to not donate sperm for the duration of the study medication treatment.
• Be reasonable stable health (i.e., diagnosed chronic illnesses that are not deemed stable by the participant's primary care physician), or in the opinion of the Investigator, based on medical history (i.e., absence of any clinically relevant abnormality) during Screening.
• Be able to understand and provide written, informed consent.
• Must be able to attend on-site and virtual study visits.

You may not qualify if:

• Complicated RARS (orbital or intracranial involvement).
• Symptoms attributed to sinus disease for longer than 4 weeks.
• RARS with multiple courses of antimicrobial therapy failures (in previous 2 years, 3 or more episodes treated with 2 or more ATBs).
• Disease history consistent with severe allergic or seasonal rhinitis (requiring oral cortico-steroids to manage intractable nasal symptoms).
• Isolated frontal and sphenoidal clinical disease (given the different pathophysiology and etiologic pathogens).
• History of nasal polyposis.
• History of abnormal sinus pathology.
• Previous sinus surgery.
• Participants with cystic fibrosis.
• Recurrent moderate epistaxis.
• Participants with chronic obstructive pulmonary disease (COPD).
• Participants with severe asthma (per European Respiratory Society (ERS)/American Thoracic Society (ATS) 2014).
• Immunocompromised participants or participants with other medical conditions that may affect interpretation of the effect of trial drugs.
• Allergic to any of the trial drugs.
• Females who are breastfeeding, pregnant, or attempting to become pregnant.

Sponsors & Collaborators

• Sanotize Research and Development corp.: lead

Study Sites (7)

Okanegan Clinical Trials

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site)

Richmond, British Columbia, V6V 2L1, Canada

Location

Cliantha Research

Mississauga, Ontario, L4W 1V7, Canada

Location

Clinical Research of Ontario

Scarborough Village, Ontario, M1S 4T7, Canada

Location

Intermed Groupe Santé

Chicoutimi, Quebec, G7H 7Y8, Canada

Location

Alpha Recherche Clinique LeBourneuf

Québec, Quebec, G2J 0C4, Canada

Location

Alpha Recherche Clinique Val-Belair

Québec, Quebec, G3K 2P8, Canada

Location

MeSH Terms

Conditions

Sinusitis; Rhinosinusitis; Recurrence

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keith Moore, PharmD

  Sanotize Research and Development corp.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A blinded participant number will be assigned to each randomized participant. Site staff/ physician will then dispense a kit labelled with the authorization number generated during randomization to the individual participant. No study investigators, associates performing assessments or participants will be aware of the study medication in the assigned treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A two-week therapy of NONS vs Placebo (saline nasal spray) initiated immediately after the onset of a new RARS episode to assess the acceleration to clinical success (cured/much-improved symptoms), lack of use of INCS (Day 5, or thereafter) and rescue oral antibiotics (ATBs) (Day 8, or thereafter) after initiation of nitric oxide-releasing solution (NORS) platform therapy.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 16, 2024
• Study Start: January 16, 2024
• Primary Completion: February 22, 2025
• Study Completion: November 22, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CA (7)