Recurrent Acute RhinosinusitisPhase 2NONS-RARS-01NCT06264141
Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis
A Phase 2 study testing Nitric Oxide Releasing Solution and Nasal spray with isotonic saline in people with Recurrent Acute Rhinosinusitis, run by Sanotize Research and Development corp. at 7 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Acute Rhinosinusitis
- What is being tested?
- Nitric Oxide Releasing Solution and Nasal spray with isotonic saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 7 sitesCanada
- Study dates
- 16 Jan 2024to 22 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Participants who have conditions that participation is not in their best interest.
- 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.
- Participants who are unable to sign the informed consent.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Intermed Groupe Santé
Chicoutimi, Quebec, G7H 7Y8
Okanegan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9
Cliantha Research
Mississauga, Ontario, L4W 1V7
Alpha Recherche Clinique LeBourneuf
Québec, Quebec, G2J 0C4
Alpha Recherche Clinique Val-Belair
Québec, Quebec, G3K 2P8
Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site)
Richmond, British Columbia, V6V 2L1
Clinical Research of Ontario
Scarborough Village, Ontario, M1S 4T7
About this study
Official title: Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 2 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) Compared to Saline Nasal Spray as an Early Treatment for Recurrent Acute Rhinosinusitis (RARS)
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.
Read the detailed description
Study Design:
This is a multicenter, randomized, double-blind placebo-controlled, two-arm, parallel-group, phase 2 clinical trial to determine the efficacy and safety of NONS to treat recurrent acute (bacterial) rhinosinusitis (RARS).
Nitric oxide-releasing solution (NORS) therapy administered as NONS, has the potential to shorten RARS episodes and may reduce the concomitant use of INCS, oral non-steroidal anti-inflammatory drugs (NSAIDS) and oral ATBs used to manage this condition. Suitable candidates will be randomized to a 2-week course of nitric oxide nasal spray (NONS) compared to saline nasal spray (1:1 ratio, administered as five doses daily). RARS symptoms efficacy response will be measured twice daily, after initiation of study medication (Day 1 to Day 15), then once daily to the end of the study (Day 16 to Day 29). 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; primary endpoint assessment at Day 8), minimize the use of INCS and the avoidance of rescue oral ATBs (both secondary endpoints) over the study period (Day 1 to Day 29). Participants will be enrolled between RARS episodes while asymptomatic, and on study for up to 4 months or until their next recurrence of RARS at which time study procedures and medication begin.
Adults (18 years or older) presenting with a history of mild to severe RARS symptoms (nasal obstruction (congestion), purulent nasal discharge, postnasal drip, headache, facial pain), signs (such as facial swelling), and other nonspecific signs/symptoms of fever and malaise are eligible.
The primary endpoint is is the time to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success) after 7 days of therapy,
- Conditions
- Recurrent Acute Rhinosinusitis
- Being tested
- Nitric Oxide Releasing Solution, Nasal spray with isotonic saline
- Keywords
- Sinusitis, Nitric oxide, RARS, NONS, Nasal spray, Rhinosinusitis, Recurrent, Acute
- Medical subject headings
- Sinusitis, Rhinosinusitis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide Releasing SolutionDrug
Also called Nitric Oxide Nasal Spray
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.
Nasal spray with isotonic salineDevice
Also called Normal saline, 0.9% 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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% Receives: Device: Nasal spray with isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days
Secondary outcomes (13)
Time (days) to full recovery from sinusitis (participant reported)
To record the rate of recovery for study participants.
Measured: 29 days
Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success)
To record the improvement of symptoms among study participants.
Measured: 29 days
Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure
To record the frequency of study participants receiving rescue antibiotics.
Measured: 29 days
Time (days) to initiation of INCS
To record the rate of study participants starting corticosteroids.
Measured: 29 days
Proportion of participants requiring INCS
To record the fraction of study participants requiring corticosteroids.
Measured: Day 5, 8, 15 & 29
Proportion of participants requiring rescue oral ATBs
To record the fraction of study participants requiring antibiotics.
Measured: Day 5, 8, 15 & 29
Proportion of participants recovered from sinusitis
To record the fraction of study participants who recover
Measured: Day 5, 8, 15 & 29
Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs
To record the fraction of study participants whose symptoms required corticosteroids and antibiotics.
Measured: 29 days
Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22
To record the fraction of study participants who show improvement in survey scores.
Measured: Day 8 & 15
Tolerability and safety of NONS
Number of participants with clinically significant changes from baseline in Adverse events
Measured: 29 days
Proportion of participants with clinically significant changes from baseline in vital signs
Vital sign measurements includes systolic/diastolic blood pressures, pulse rate, respiratory rate and body temperature
Measured: 29 days
Proportion of participants with clinically significant changes from baseline in laboratory parameters
Laboratory investigation includes hematology and chemistry panels
Measured: 29 days
Number of participants with clinically significant changes from Baseline in physical examinations
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start16 Jan 2024
- Primary completion22 Feb 2025
- Study completion22 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Acute RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanotize Research and Development corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Moore, PharmD, Study director, Sanotize Research and Development corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264141
- Sponsor's protocol ID
- NONS-RARS-01
- Acronym
- NONS-RARS-01
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blinded, Placebo-controlled, Phase 2 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) Compared to Saline Nasal Spray as an Early Treatment for Recurrent Acute Rhinosinusitis (RARS)
- ClinicalTrials.gov ID
- NCT06264141
- Acronym / sponsor ID
- NONS-RARS-01 / NONS-RARS-01
- Conditions
- Recurrent Acute Rhinosinusitis
- Keywords
- Sinusitis, Nitric oxide, RARS, NONS, Nasal spray, Rhinosinusitis, Recurrent, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Sanotize Research and Development corp.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 22 Nov 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
This is a multicenter, randomized, double-blind placebo-controlled, two-arm, parallel-group, phase 2 clinical trial to determine the efficacy and safety of NONS to treat recurrent acute (bacterial) rhinosinusitis (RARS).
Nitric oxide-releasing solution (NORS) therapy administered as NONS, has the potential to shorten RARS episodes and may reduce the concomitant use of INCS, oral non-steroidal anti-inflammatory drugs (NSAIDS) and oral ATBs used to manage this condition. Suitable candidates will be randomized to a 2-week course of nitric oxide nasal spray (NONS) compared to saline nasal spray (1:1 ratio, administered as five doses daily). RARS symptoms efficacy response will be measured twice daily, after initiation of study medication (Day 1 to Day 15), then once daily to the end of the study (Day 16 to Day 29). 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; primary endpoint assessment at Day 8), minimize the use of INCS and the avoidance of rescue oral ATBs (both secondary endpoints) over the study period (Day 1 to Day 29). Participants will be enrolled between RARS episodes while asymptomatic, and on study for up to 4 months or until their next recurrence of RARS at which time study procedures and medication begin.
Adults (18 years or older) presenting with a history of mild to severe RARS symptoms (nasal obstruction (congestion), purulent nasal discharge, postnasal drip, headache, facial pain), signs (such as facial swelling), and other nonspecific signs/symptoms of fever and malaise are eligible.
The primary endpoint is is the time to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success) after 7 days of therapy,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide Releasing Solution | Active comparator | Drug: Nitric Oxide Releasing SolutionNasal 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 |
| Placebo | Placebo comparator | Device: Nasal spray with isotonic salineNasal 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric Oxide Releasing SolutionAlso: Nitric Oxide Nasal SprayThe 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. | Drug | Nitric Oxide Releasing Solution |
| Nasal spray with isotonic salineAlso: Normal saline, 0.9% salineThe 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. | Device | Placebo |
Primary outcome
Primary endpoint is the time to sinus symptoms resolution
Time frame: 8 days
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.
13 secondary outcomes
Time (days) to full recovery from sinusitis (participant reported)
Time frame: 29 days
Time (days) to sinus symptoms resolution, i.e., being cured or much improved (participant reported clinical success)
Time frame: 29 days
Time (days) to the initiation of rescue oral ATB(s), i.e., treatment failure i.e., treatment failure
Time frame: 29 days
Time (days) to initiation of INCS
Time frame: 29 days
Proportion of participants requiring INCS
Time frame: Day 5, 8, 15 & 29
Proportion of participants requiring rescue oral ATBs
Time frame: Day 5, 8, 15 & 29
Proportion of participants recovered from sinusitis
Time frame: Day 5, 8, 15 & 29
Proportion of participants with rapidly worsening symptoms requiring the use of INCS and oral ATBs
Time frame: 29 days
Proportion of participants achieving at least a 9-point improvement change from baseline in Sinonasal Outcome Test (SNOT)-22
Time frame: Day 8 & 15
Tolerability and safety of NONS
Time frame: 29 days
Proportion of participants with clinically significant changes from baseline in vital signs
Time frame: 29 days
Proportion of participants with clinically significant changes from baseline in laboratory parameters
Time frame: 29 days
Number of participants with clinically significant changes from Baseline in physical examinations
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Moore, PharmD study director
Sanotize Research and Development corp.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide Releasing Solution and Nasal spray with isotonic saline in people with Recurrent Acute Rhinosinusitis, run by Sanotize Research and Development corp. at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint is the time to sinus symptoms resolution (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.