Could a simple nasal spray replace antibiotics for sinusitis?
NCT ID NCT06264141
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a nitric oxide nasal spray against a saline placebo in 162 adults with recurrent acute sinusitis. Participants used the spray at the first sign of a new episode for two weeks. The goal was to see if the nitric oxide spray speeds up symptom relief and reduces the need for steroid sprays or antibiotics.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nitric oxide nasal spray
- What this could lead to
- If it works, this could offer a fast-acting, drug-free option to ease sinusitis symptoms and cut down on antibiotic use.
- What could go wrong
- This is a small Phase 2 study, so results may not hold up in larger trials. The spray is compared to saline, not standard care, and benefits may be modest.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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162 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At least aged 18 years old at the time of consent (19 years depending on the age of majority in the Canadian province/territory). 2. 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). 3. 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. 4. 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. 5. 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. 6. 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. 7. Be able to understand and provide written, informed consent. 8. Must be able to attend on-site and virtual study visits. Exclusion Criteria: 1. Complicated RARS (orbital or intracranial involvement). 2. Symptoms attributed to sinus disease for longer than 4 weeks. 3. RARS with multiple courses of antimicrobial therapy failures (in previous 2 years, 3 or more episodes treated with 2 or more ATBs). 4. Disease history consistent with severe allergic or seasonal rhinitis (requiring oral cortico-steroids to manage intractable nasal symptoms). 5. Isolated frontal and sphenoidal clinical disease (given the different pathophysiology and etiologic pathogens). 6. History of nasal polyposis. 7. History of abnormal sinus pathology. 8. Previous sinus surgery. 9. Participants with cystic fibrosis. 10. Recurrent moderate epistaxis. 11. Participants with chronic obstructive pulmonary disease (COPD). 12. Participants with severe asthma (per European Respiratory Society (ERS)/American Thoracic Society (ATS) 2014). 13. Immunocompromised participants or participants with other medical conditions that may affect interpretation of the effect of trial drugs. 14. Allergic to any of the trial drugs. 15. Females who are breastfeeding, pregnant, or attempting to become pregnant. 16. Participants who have conditions that participation is not in their best interest. 17. 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. 18. Participants who are unable to sign the informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alpha Recherche Clinique LeBourneuf
Québec, Quebec, G2J 0C4, Canada
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Alpha Recherche Clinique Val-Belair
Québec, Quebec, G3K 2P8, Canada
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Cliantha Research
Mississauga, Ontario, L4W 1V7, Canada
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Clinical Research of Ontario
Scarborough Village, Ontario, M1S 4T7, Canada
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Intermed Groupe Santé
Chicoutimi, Quebec, G7H 7Y8, Canada
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Okanegan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
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Richmond Clinical Trials (Okanagan Clinical Trials Satelite Site)
Richmond, British Columbia, V6V 2L1, Canada