Nitric Oxide Nasal Spray for Sinus Infections

(NONS-RARS-01 Trial)

Recruiting at 6 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

162 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Keith Moore, PharmD

Principal Investigator

Sanotize Research and Development corp.

Eligibility Criteria

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

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

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 had issues with my sinuses before.

Timeline

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

Treatment Details

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.

Participant Groups

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+