← Back to Search

Virus Therapy

Nitric Oxide Releasing Solution for Acute Sinusitis (NONS-RARS-01 Trial)

Phase 2
Recruiting
Research Sponsored by Sanotize Research and Development corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
At least aged 18 years old at the time of consent (19 years depending on the age of majority in the Canadian province/territory)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 5, 8, 15 & 29
Awards & highlights

NONS-RARS-01 Trial Summary

"This trial compares a nasal spray with nitric oxide to a saline nasal spray for treating recurrent acute rhinosinusitis. The study aims to see if the nitric oxide nasal spray can help patients recover

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include irritation inside the nose, sneezing, or a runny nose due to the ingredients in the nasal sprays.

NONS-RARS-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had at least three sinus infections in the last year, two needed antibiotics.
Select...
I am at least 18 years old, or 19 depending on where I live in Canada.

NONS-RARS-01 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 5, 8, 15 & 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 5, 8, 15 & 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary endpoint is the time to sinus symptoms resolution
Secondary outcome measures
Number of participants with clinically significant changes from Baseline in physical examinations
Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22
Proportion of participants recovered from sinusitis
+10 more
Other outcome measures
Number of ATB courses required as a rescue treatment
Proportion of participants achieving at least a 50% reduction in sinusitis symptoms (by MRSS)
Proportion of participants being cured or much improved for each symptom
+3 more

NONS-RARS-01 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Nitric Oxide Releasing SolutionActive Control1 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: PlaceboPlacebo Group1 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%

Find a Location

Who is running the clinical trial?

Sanotize Research and Development corp.Lead Sponsor
8 Previous Clinical Trials
1,964 Total Patients Enrolled
Keith Moore, PharmDStudy DirectorSanotize Research and Development corp.
1 Previous Clinical Trials
190 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"As indicated on clinicaltrials.gov, this research investigation is presently seeking eligible individuals. The trial was initially disclosed on January 16th, 2024, and the most recent revision occurred on February 9th of the same year."

Answered by AI

What is the upper limit for patient participation in this medical investigation?

"Yes, the details available on clinicaltrials.gov website indicate that this investigation is presently enrolling participants. The trial was first listed on January 16th, 2024, and its most recent modification was made on February 9th, 2024. A total of 186 individuals will be enrolled across seven designated locations."

Answered by AI

At how many distinct locations is this clinical trial currently being conducted?

"Among the 7 active sites for this research, notable locations include Okanegan Clinical Trials in Kelowna and its satellite site in Richmond, along with Intermed Groupe Santé in Chicoutimi."

Answered by AI

What are the potential risks associated with the Nitric Oxide Releasing Solution for individuals?

"Based on our assessment for this Phase 2 trial, the safety rating of Nitric Oxide Releasing Solution is considered a 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis
2024. "Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06264141.
~46 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top