Nitric Oxide Nasal Spray for Sinus Infections

(NONS-RARS-01 Trial)

Not currently recruiting at 9 trial locations

Overseen By Jonathan Leemhuis, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanotize Research and Development corp.

Must not be taking: Oral corticosteroids

Disqualifiers: Severe asthma, COPD, Cystic fibrosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nasal spray with nitric oxide to determine if it can help people with recurrent sinus infections recover more quickly. The goal is to compare this spray to a simple saline spray and assess whether it reduces the need for other treatments like steroids or antibiotics. The trial seeks participants who have experienced at least three sinus infections in the past year, with some episodes requiring antibiotic treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that nitric oxide nasal spray (NONS) has been tested in people before. In earlier studies, the spray proved both effective and safe. For instance, it helped reduce the virus load in COVID-19 patients. These studies reported that participants tolerated the treatment well, with no major side effects.

It's important to note that the nasal spray has already undergone testing in at least one human trial, confirming its safety in people. Since this current trial is in a middle phase, it indicates the treatment has shown some safety in earlier stages. However, further testing is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sinus infections?

Unlike the standard treatments for sinus infections, which often involve antibiotics or corticosteroids, the Nitric Oxide Nasal Spray (NONS) introduces a novel mechanism by releasing nitric oxide directly into the nasal passages. This active ingredient is known for its antimicrobial properties, potentially targeting the infection more directly and effectively. Researchers are excited about this approach because it may offer a quicker and more targeted relief for sinus infections without the systemic effects associated with antibiotics or steroids. Additionally, the nasal spray format allows for easy and frequent administration, maximizing the therapeutic benefits right at the source of the infection.

What evidence suggests that this treatment might be an effective treatment for sinus infections?

Research has shown that a nasal spray containing nitric oxide (NONS) might help people recover from sinus infections more quickly. In this trial, participants will receive either the Nitric Oxide Releasing Solution or a placebo. Studies have indicated that NONS can reduce symptoms of respiratory infections and quickly lower the amount of virus in the body. For sinus infections, NONS aims to ease symptoms faster and reduce the need for steroids and antibiotics. It releases nitric oxide, which can help fight infections. Although more research is needed, early results are encouraging for those with frequent sinus problems. ^{1 2 5 6 7}

Who Is on the Research Team?

Keith Moore, PharmD

Principal Investigator

Sanotize Research and Development corp.

Are You a Good Fit for This Trial?

This trial is for individuals experiencing repeated episodes of acute sinusitis, who are starting to show symptoms again. Participants should not have used intranasal corticosteroids or oral antibiotics shortly before the trial.

Inclusion Criteria

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

I've had at least three sinus infections in the last year, two needed antibiotics.

Exclusion Criteria

Participants whose participation in the study, in the opinion of the Investigator, have a condition which would interfere with their ability to adhere to the protocol (e.g., participants whom are mentally or neurologically disabled and whom are considered not fit to their participation in the study), interfere with the assessment of the investigational product, or compromise the safety of the participant or the quality of the data

I have severe allergies or hay fever that need steroids to manage.

I have had issues with my sinuses before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 2-week course of nitric oxide nasal spray (NONS) or saline nasal spray, administered five times daily.

2 weeks

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptom resolution and use of additional medications.

2 weeks

Daily symptom monitoring

Extended Follow-up

Participants continue to be monitored for up to 4 months or until their next recurrence of RARS.

Up to 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Nitric Oxide Nasal Spray (NONS)

Trial Overview The study tests if a nitric oxide nasal spray can speed up recovery and reduce the need for steroids and antibiotics in recurrent sinus infections compared to a saline (saltwater) nasal spray placebo.

How Is the Trial Designed?

Group I: Nitric Oxide Releasing Solution Active Control 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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%

Who Is Running the Clinical Trial?

Sanotize Research and Development corp.

Lead Sponsor

Trials

9

Recruited

2,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06264141

Evaluation of Nitric Oxide Nasal Spray (NONS) for ... The goal of NONS therapy is to accelerate the time to achieve RARS symptoms resolution, defined as a clinical success (cured or much improved sinusitis symptoms ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8117664/

Clinical efficacy of nitric oxide nasal spray (NONS) for the ... A rapid reduction (95%) in the SARS-CoV-2 viral load was observed within 24 hours, with a 99% reduction observed within 72 hours with NONS ...

3. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(23)01365-X/fulltext

Two Randomized Controlled Trials (ReOpen1 and ReOpen2) Acute disease exacerbations were reduced by 56% to 66% with EDS-FLU versus EDS-placebo (P = .001). There were significant, and similar magnitude ...

4. withpower.com withpower.com/trial/phase-2-sinusitis-2024-0dbeb

Nitric Oxide Nasal Spray for Sinus Infections Trial Overview The study tests if a nitric oxide nasal spray can speed up recovery and reduce the need for steroids and antibiotics in recurrent sinus ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06264141/evaluation-of-nitric-oxide-nasal-spray-nons-for-treatment-of-recurrent-acute-rhinosinusitis

Evaluation of Nitric Oxide Nasal Spray (NONS) for ... This is a multicenter, randomized, double-blind placebo-controlled, two-arm, parallel-group, phase 2 clinical trial to determine the efficacy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9969373/

Nasal sprays for treating COVID-19: a scientific note - PMC A nitric oxide nasal spray (NONS) manufactured by SaNOtize was found to reduce COVID-19 viral loads to significant levels in patients [56, 57].

7. isrctn.com isrctn.com/editorial/retrieveFile/a36fee2f-b667-4887-8c80-c832ebc5cd74/42703

USUAL CARE + NITRIC OXIDE NASAL SPRAY 1. ... Nitric oxide nasal spray (NONS) is a nitric oxide (NO) donor that has been found to be effective and safe in reducing viral load and.