Natural oil spray may allow lower steroid doses for sinusitis sufferers

NCT ID NCT07787494

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Armonia Centro Polispecialistico

    Armonia Centro Polispecialistico, Porto Mantovano, 46047, Italy

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