Natural oil spray may allow lower steroid doses for sinusitis sufferers
NCT ID NCT07787494
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This trial tests whether adding a nasal spray made from Pistacia lentiscus oil (Bactorinol®) can help people with chronic rhinosinusitis maintain their quality of life when their steroid nasal spray dose is reduced. Participants first use a full dose of mometasone for 12 weeks, then switch to a half dose combined with the oil spray for another 12 weeks. The study measures changes in sinus symptoms and quality of life to see if the oil spray can compensate for the lower steroid dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mometasone furoate nasal spray and Bactorinol® nasal spray (a medical device containing Pistacia lentiscus oil)
- What this could lead to
- If successful, this could allow people with chronic rhinosinusitis to use a lower dose of steroids while maintaining symptom control, potentially reducing steroid-related side effects.
- What could go wrong
- This is a small, single-arm trial without a placebo group, so results may not be definitive. The oil spray may not fully compensate for the reduced steroid dose, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Age ≥18 years. * Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) or without nasal polyposis (CRSsNP). * Clinical indication for treatment with an intranasal corticosteroid (mometasone furoate). * Ability to understand and sign informed consent. * Willingness to comply with the study protocol and follow-up visits. Exclusion Criteria: * Neoplastic pathologies of all degrees. * Neurological or psychiatric disorders that may impair adherence to treatment and/or understanding of the informed consent form. * Pregnancy or lactation. * Chronic drug and/or alcohol use. * Immunosuppression, including primary immunodepression, oncological pathology undergoing active chemotherapy/immunotherapy, or autoimmune pathology undergoing immunosuppressive treatment. * Known or suspected allergy to one or more excipients/components of the preparation under study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Armonia Centro Polispecialistico
Armonia Centro Polispecialistico, Porto Mantovano, 46047, Italy
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